antenatal late preterm steroids trial

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Antenatal late preterm steroids trial

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Severe respiratory complications, transient tachypnea of the newborn, surfactant use, and bronchopulmonary dysplasia also occurred significantly less frequently in the betamethasone group. There were no significant between-group differences in the incidence of chorioamnionitis or neonatal sepsis. Neonatal hypoglycemia was more common in the betamethasone group than in the placebo group Conclusions: Administration of betamethasone to women at risk for late preterm delivery significantly reduced the rate of neonatal respiratory complications.

Abstract Background: Infants who are born at 34 to 36 weeks of gestation late preterm are at greater risk for adverse respiratory and other outcomes than those born at 37 weeks of gestation or later. Substances Glucocorticoids Pulmonary Surfactants Betamethasone. Late preterm infants also have a higher mortality for all causes when compared to term infants. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period.

If shown to reduce the need for respiratory support and thus to decrease the rate of special care nursery admissions and improve short-term outcomes, the public health and economic impact will be considerate. This protocol describes a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of neonatal intensive care unit NICU admissions and improving short-term outcomes in the late preterm infant.

Two follow-up studies will be conducted concurrently. The first follow-up study will examine if the positive effects of betamethasone on lung function will persist in children at 6 years of age of mothers randomized to betamethasone with an expected late preterm delivery. Neonatal respiratory morbidity is associated with an increased risk of adverse childhood respiratory disease.

Thus it is quite plausible that the effect of betamethasone, in reducing neonatal morbidity, particularly TTN, will translate into improved respiratory morbidity in early childhood. The primary outcome is childhood respiratory disease defined by a composite outcome of abnormal pulmonary function test PFT measured by spirometry, physician diagnosis of asthma, or other respiratory illnesses with medication. The second follow-up study will examine whether late preterm antenatal betamethasone treatment is associated with long-term neurocognitive functioning, and whether there are any long-term consequences of what is believed to be transient neonatal hypoglycemia.

Cognitive function will be measured by the Differential Ability Scales 2nd Edition DAS-II core components of the general conceptual ability GCA that includes verbal ability, non-verbal reasoning ability and spatial ability.

Except for the duration of CPAP or high-flow nasal cannula and the duration of a fraction of inspired oxygen of 0. Neonates Needing Immediate Resuscitation After Birth [ Time Frame: Within the first 30 minutes of birth ] Need for resuscitation after birth: any intervention in the first 30 minutes other than blow-by oxygen Number of Neonates With Respiratory Distress Syndrome [ Time Frame: Delivery ] Respiratory distress defined as the presence of clinical signs of respiratory distress tachypnea, retractions, flaring, grunting, or cyanosis with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates Number of Neonates With Transient Tachypnea of the Newborn [ Time Frame: by 72 hours after delivery ] TTN is defined as signs of respiratory distress, specifically tachypnea, that are resolved by 72 hours of age.

TTN may be diagnosed in the absence of a chest X-ray or with a chest X-ray that is normal or shows signs of increased perihilar interstitial markings Number of Infants With Neonatal Apnea [ Time Frame: 72 hours of life ] Neonatal apnea with respiratory pauses of more than 20 seconds duration resulting in bradycardia or oxygen desaturation below baseline.

Stage 2: Clinical signs and symptoms with pneumatosis intestinalis on radiographs. Stage 3: Advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation. For analysis purposes, death before discharge is assigned maximum rank Median Length of Hospital Stay [ Time Frame: Duration of hospital stay following delivery up to 2 weeks ] Median length of maternal hospital stay following delivery Maternal Outcomes Participant-based [ Time Frame: Labor and delivery through 72 hours post partum ] Chorioamnionitis: clinical diagnosis and a body temperature of at least Talk with your doctor and family members or friends about deciding to join a study.

To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Singleton Pregnancy. A twin pregnancy reduced to singleton either spontaneously or therapeutically before 14,0 weeks by project gestational age is acceptable. Gestational age at randomization between 34,0 weeks and 36,5 weeks confirmed by study criteria.

High probability of delivery in the late preterm period any one of the following :. Delivery expected within 12 hours of randomization, because of insufficient time of corticosteroids to confer benefit, including any of the following:. Rupture of Membranes ROM does not satisfy protocol criteria - exclude if the patient being evaluated for Preterm Premature Rupture of Membranes pPROM , does not have preterm labor or planned delivery and does not satisfy the spontaneous membrane rupture criteria any 2 of: positive Nitrazine test, pooling of fluid in the vaginal vault test or ferning of vaginal fluid; or indigo carmine pooling in the vagina after amnioinfusion; or visible leakage of amniotic fluid from the cervix B.

Rupture of the membranes in the presence of more than 6 contractions per hour or cervical dilation of 3 cm or more, unless oxytocin was withheld for at least 12 hours other induction agents allowed C. Chorioamnionitis - exclude if patient is diagnosed with chorioamnionitis D. Evidence of non-reassuring fetal status requiring immediate delivery. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Results First Posted : January 30, Last Update Posted : July 28, Study Description.

This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. Detailed Description:. FDA Resources. Arms and Interventions. The active study drug, betamethasone. A similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart.

Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart. Outcome Measures. Secondary Outcome Measures : Number of Neonates With Severe Respiratory Complication, [ Time Frame: 72 hours of life ] A severe respiratory complication was defined as any of the following occurrences within 72 hours after birth: CPAP or high-flow nasal cannula for at least 12 hours, supplemental oxygen with a fraction of inspired oxygen of 0.

Need for resuscitation after birth: any intervention in the first 30 minutes other than blow-by oxygen. Respiratory distress defined as the presence of clinical signs of respiratory distress tachypnea, retractions, flaring, grunting, or cyanosis with an oxygen requirement and a chest x-ray that shows hypoaeration and reticulogranular infiltrates.

TTN is defined as signs of respiratory distress, specifically tachypnea, that are resolved by 72 hours of age. TTN may be diagnosed in the absence of a chest X-ray or with a chest X-ray that is normal or shows signs of increased perihilar interstitial markings.

Neonatal apnea with respiratory pauses of more than 20 seconds duration resulting in bradycardia or oxygen desaturation below baseline. Infants requiring supplemental oxygen of more than 0. Administration of surfactant for neonatal respiratory treatment. Neonatal death after 72 hours of life but before hospital discharge. Neonates whose birth weight is less than the 10th percentile at delivery.

Defined as modified Bell Stage 2 or 3. A composite endpoint of morbidities known to be affected by steroid administration will also be evaluated. Median length of time from delivery until the first neonatal feeding. Inability of the neonate to take all feeds po , i. Includes need for NICU or intermediate care admission and length of stay if admitted. For analysis purposes, death before discharge is assigned maximum rank. Median length of maternal hospital stay following delivery.

Chorioamnionitis: clinical diagnosis and a body temperature of at least Median interval of hours from randomization to delivery. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Singleton Pregnancy.

A twin pregnancy reduced to singleton either spontaneously or therapeutically before 14,0 weeks by project gestational age is acceptable Gestational age at randomization between 34,0 weeks and 36,5 weeks confirmed by study criteria High probability of delivery in the late preterm period any one of the following : Membrane rupture as defined by the occurrence of any two of the following: pooling of fluid in the vaginal vault, positive Nitrazine test, ferning of vaginal fluid, positive AmniSure test; or any one of the following: indigo carmine pooling in the vagina after amnioinfustion, visible leakage of amniotic fluid from the cervix or Preterm labor with intact membranes.

An induction must be scheduled to start by 36,5 weeks at the latest, whereas a cesarean delivery must be scheduled by 36,6 weeks at the latest. Therefore the latest gestational age for randomization is 36,4 weeks for a planned induction. Evidence of non-reassuring fetal status requiring immediate delivery Participation in another interventional study that influences neonatal morbidity and mortality Participation in this trial in a previous pregnancy Delivery at a non-network hospital At 36, 0 weeks to 36, 5 weeks and quota for 36 weeks already met.

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Therefore, corticosteroids should not be administered unless there is substantial clinical concern for imminent preterm birth. Specific data on the use of corticosteroids in the periviable period are supported by a combination of laboratory data on the response of lung tissue and clinical observational studies 1 2 17 The use of antenatal corticosteroid administration after preterm PROM has been evaluated in a number of clinical trials and has been shown to reduce neonatal mortality, respiratory distress syndrome, intraventricular hemorrhage, and necrotizing enterocolitis 6 12 19 Current data suggest that antenatal corticosteroids are not associated with increased risks of maternal or neonatal infection regardless of gestational age.

Whether to administer a repeat or rescue course of corticosteroids with preterm PROM is controversial, and there is insufficient evidence to make a recommendation for or against see Single Rescue Course. A Cochrane review concluded that although antenatal corticosteroids are beneficial in singleton gestations, further research is required to demonstrate an improvement in outcomes for multifetal gestations 21 More recently, a well-designed retrospective cohort study concluded that administration of a complete course of antenatal corticosteroids 1—7 days before birth in twin pregnancies is associated with a clinically significant decrease in neonatal mortality, short-term respiratory morbidity, and severe neurological injury that is similar in magnitude to that observed among singletons The Maternal Fetal Medicine Units MFMU Network Antenatal Late Preterm Steroids trial 24 was a double-blind, placebo-controlled, randomized clinical trial designed to evaluate the use of antenatal betamethasone for pregnant women at high risk of delivery in the late preterm period.

Women were identified to be at high risk if they presented in preterm labor, had preterm PROM, or if they had a planned delivery in the late preterm period, with the indication at the discretion of the obstetrician—gynecologist or other health care provider.

Tocolysis was not employed as a part of this trial, and delivery was not delayed for obstetric or medical indications. The study found that the administration of betamethasone led to a significant decrease in the primary outcome, which was the need for respiratory support. A larger decrease was demonstrated for severe respiratory complications, from There were also significant decreases in the rates of transient tachypnea of the newborn; bronchopulmonary dysplasia; a composite of respiratory distress syndrome RDS , transient tachypnea of the newborn and RDS; and the need for postnatal surfactant.

Infants exposed to betamethasone were less likely to require immediate postnatal resuscitation. There was no increase in proven neonatal sepsis, chorioamnionitis, or endometritis with late preterm betamethasone. Hypoglycemia was more common in the infants exposed to betamethasone The rates of hypoglycemia found in the trial are similar to what is reported in the general population of late preterm infants Although not studied in this trial, long-term adverse outcomes of prolonged and persistent neonatal hypoglycemia have been described 26 The American Academy of Pediatrics recommends the monitoring of neonatal blood sugars for late preterm infants because late preterm birth is a known risk factor for hypoglycemia.

There are important considerations specific to the administration of late preterm corticosteroids that should be noted and are derived from the methodology used by the trial. Late preterm administration of antenatal corticosteroids is not indicated in women diagnosed with clinical chorioamnionitis intrauterine infection Furthermore, tocolysis should not be used in an attempt to delay delivery in order to administer antenatal corticosteroids in the late preterm period, nor should an indicated late preterm delivery such as for preeclampsia with severe features be postponed for corticosteroid administration Groups not studied by the Antenatal Late Preterm Steroids trial include women with multiple gestations, women with pregestational diabetes, women who previously had received a course of corticosteroids, and women who gave birth by cesarean at term.

Whether or not late preterm corticosteroids provide benefit in these populations is unknown. Because of concerns for maternal and fetal harm, and the balance of risk and benefits, planned multiple courses are not recommended. In a randomized trial of single versus serial courses of antenatal corticosteroids, a reduction in birth weight and an increase in the number of infants who were small for gestational age were found, especially after four courses of corticosteroids Although not consistent, six studies found decreased birth weight and head circumference with repeat courses 29 30 31 32 33 34 35 and three studies did not 36 37 Follow-up of children at 2 years of age who were exposed to repeat courses of antenatal corticosteroids showed no significant difference in physical or neurocognitive measures in two studies 39 40 , and the same outcome was found in younger children in a third study Although not statistically significant, the relative risk of cerebral palsy in infants exposed to serial courses of antenatal corticosteroids RR, 5.

Maternal effects include increased risk of infection and suppression of the hypothalamic—pituitary—adrenal axis 31 Regularly scheduled repeat courses or serial courses more than two are not currently recommended Although the initial data 43 suggested the benefit of corticosteroids may decrease after 7 days, the duration of corticosteroid benefit remains controversial No increase in newborn complications or intrauterine growth restriction was identified, although the power to evaluate these individual outcomes was low.

There was no difference in bronchopulmonary dysplasia, and long-term outcome developmental data are not available for these patients. The Crowther Cochrane meta-analysis 10 trials, 4, women and 5, infants included trials with a repeat course of corticosteroids as early as 7 days from initial course.

The results of the meta-analysis showed reduction in RDS and there was noted an associated small reduction in size at birth, but no significant adverse outcomes. Rescue course corticosteroids could be provided as early as 7 days from the prior dose, if indicated by the clinical scenario, given the Cochrane meta-analysis results 11 Whether to administer a rescue course of corticosteroids with PROM is controversial, and there is insufficient evidence to make a recommendation for or against 6 The concern that corticosteroids may have the potential to adversely affect neurodevelopmental outcomes is largely based on animal data and from studies of multiple course corticosteroids The MFMU study of repeat course corticosteroids suggested that four or more courses may be associated with the development of cerebral palsy This single signal does not lead us to caution against corticosteroid use, particularly as it refers to term exposure, but continued surveillance of long-term outcomes should be supported.

The year neurodevelopmental follow-up of this cohort were exposed to corticosteroids from Cognitive functioning as measured by the Weschler scales, working memory and attention, and other neurocognitive assessments were not different between exposure groups. The MFMU Antenatal Late Preterm Steroids study has not yet obtained long-term outcome data but doing so would add significantly to limited available literature. A final additional consideration regarding corticosteroid risks is that in the context of maternal critical care, antenatal corticosteroids are not contraindicated, even in the setting of sepsis 1 Perinatal Quality Collaboratives, such as the Ohio Perinatal Quality Collaborative, California Perinatal Quality Care Collaborative, and the March of Dimes Big 5 State Perinatal Collaborative have worked to improve use of antenatal corticosteroids through a focus on the identification of missed opportunities and use of quality improvement strategies to optimize appropriate and timely antenatal corticosteroid administration.

Implementation of preterm labor assessment toolkits, standardized order sets for women at risk of early delivery, timely availability of medication in settings where pregnant women are cared for, maternal transfer protocols that indicate corticosteroids should be given before transport, and appropriate documentation of first course and rescue course antenatal corticosteroids in inpatient and outpatient health records, have been among the proposed strategies to improve appropriate and timely antenatal corticosteroid use.

One study reported qualitative focus group data describing conditions that enable delivery of antenatal corticosteroids with high reliability at hospitals that participated in the Ohio Perinatal Quality Collaborative antenatal corticosteroid project Six major themes supporting reliable implementation of antenatal corticosteroids were described, including 1 presence of a high reliability culture, 2 processes that emphasize high reliability, 3 timely and efficient administration process, 4 involvement of multiple disciplines, 5 evidence of benefit supports antenatal corticosteroid use, and 6 benefit is recognized at all levels of the care team.

Participating obstetrician—gynecologists or other health care providers and staff described that these key processes and supports were needed to ensure appropriate and timely delivery of antenatal corticosteroids with high reliability A collaborative of 54 hospitals from across the Big 5 States has been convened to pilot the new resources to standardize the identification of eligible patients and to improve the appropriate timing of corticosteroid therapy.

The Ohio Perinatal Quality Collaborative reported that antenatal corticosteroid rates increase and are maintained at high levels when hospitals are aware that antenatal corticosteroid use is monitored, and missed opportunities are identified and reviewed. The collaborative worked with Ohio vital records to add antenatal corticosteroid administration to the Ohio birth certificate registry.

Monitoring hospital rates provided incentive for hospitals to improve appropriate administration and documentation. This work by state and regional collaboratives demonstrates that quality improvement strategies to optimize appropriate and timely antenatal corticosteroid administration are effective and should be encouraged.

Therefore, the administration of antenatal corticosteroids should be monitored and missed opportunities reviewed. Overuse of antenatal corticosteroids was recently addressed at the Society for Maternal—Fetal Medicine conference in In view of this, it is critical to have ongoing development of strategies that encourage timely corticosteroid administration to women at risk of preterm delivery within 7 days and avoid overuse of corticosteroids for low risk women.

Collecting measures that track antenatal corticosteroids use for infants born before 34 weeks of gestation and timing of corticosteroids in relation to delivery will support quality improvement efforts to optimize appropriate and timely antenatal corticosteroid administration. The American College of Obstetricians and Gynecologists has identified additional resources on topics related to this document that may be helpful for ob-gyns, other health care providers, and patients. You may view these resources at www.

These resources are for information only and are not meant to be comprehensive. The resources may change without notice. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted on the Internet, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the publisher. It is important to consider the implications of our results for clinical practice.

The NNT to prevent one case of any respiratory support and need for resuscitation at birth was 20 and 16 respectively. In comparison, the NNT for harm was 13 for neonatal hypoglycaemia. LPNs are at high risk of hypoglycaemia due to poor substrate and underdeveloped compensatory response. The increased risk of neonatal hypoglycaemia might be due to transient hyperinsulinemia following maternal hyperglycaemia in response to ANC [ 37 ].

The definition of neonatal hypoglycaemia varied in the RCTs included in our review. Hypoglycaemia is an independent predictor of poor neurodevelopmental outcomes in neonates. Inability to predict spontaneous preterm birth means inevitable unwarranted exposure to ANC in a significant number of late preterm pregnancies, which do not result in late preterm delivery.

Overall, potential long-term neurodevelopmental adverse effects of ANC must receive due attention considering that none of the included trials till date have reported such data. The limitations of using Apgar scores as a primary outcome need to be discussed.

Apgar score at 1 minute does not correlate with mortality and long-term neurodevelopmental outcomes [ 40 ]. Apgar scores can be low in otherwise well preterm neonates with no evidence of perinatal asphyxia [ 40 — 42 ]. Moreover, being a continuous measure, it is much more likely that differences would be noted regardless of their clinical importance. The strengths of our review include its robust methodology, inclusions of only RCTs, large sample size and use of GRADE guidelines for summarizing the level of evidence.

We conducted sensitivity analysis excluding the studies with high ROB. The provision of the NNT for both, benefit and harm, is important for guiding research and clinical practice. The limitations of our review include the fact that the pooled results are still influenced by the large ALPS trial [ 10 ].

The included RCTs differ in the definitions of various outcomes, type of steroids, and their dosage. Furthermore, analysis stratified by gestation, mode of delivery or maternal diabetic status was not possible. Our systematic review showed that exposure to ANC was beneficial in reducing the need for respiratory support but with an increased risk of hypoglycemia in neonates born at late preterm gestation. In summary, moderate to low-quality evidence indicates that ANC exposure reduced the need for respiratory support and increased the risk of neonatal hypoglycaemia in LPNs.

The increased risk of neonatal hypoglycaemia is a serious concern. Pragmatic and adequately powered multicentre RCTs with long-term follow up assessing neonatal neurodevelopmental outcomes are needed to assess the efficacy and safety of ANC. Stratification by gestation, mode of delivery, maternal diabetes and other risk factors for respiratory distress is desirable in such trials. Pending results of such trials rigorous monitoring, treatment, and follow up of LPNs exposed to ANC is critical, more so in the context of hypoglycemia.

Submission declaration : All authors declare that the work submitted has not been published previously, that it is not under consideration for publication elsewhere, that its publication is approved by all authors and tacitly or explicitly by the responsible authorities where the work was carried out, and that, if accepted, it will not be published elsewhere including electronically in the same form, in English or in any other language, without the written consent of the copyright-holder.

Browse Subject Areas? Click through the PLOS taxonomy to find articles in your field. Abstract Background Administration of antenatal corticosteroids ANC for impending preterm delivery beyond 34 weeks of gestation continues to be a controversial issue despite various guidelines for obstetricians and gynaecologists.

Conclusions Moderate quality evidence indicates that ANC exposure reduced need for respiratory support, and increased the risk of hypoglycaemia in late preterm neonates. Funding: The authors received no specific funding for this work. Participants Inclusion criteria. Exclusion criteria. Major chromosomal and congenital anomalies.

Search strategy. Study selection. Data extraction and management. Data synthesis. Assessment of publication bias. Grading the evidence and summary of findings. Results The literature search retrieved potentially relevant citations Fig 1.

Download: PPT. Fig 1. Flow chart of study selection process after screening of electronic search. Table 1. Need for any respiratory support was significantly less in the ANC vs. The number needed to treat NNT for preventing one case of respiratory support was 20 Fig 3.

Hypoglycaemia : Four studies that reported this outcome included neonates ANC: , Control: [ 10 , 20 , 21 , 25 ]. Incidence of hypoglycaemia was significantly high in the ANC vs. Control: The number needed for harm for hypoglycemia was 13 Fig 4.

Secondary outcomes Need for resuscitation at birth [only in delivery room immediately after birth not in NICU ]: The data for this outcome was available from 6 studies that included neonates ANC: , Control: [ 10 , 21 — 25 ]. Need for resuscitation at birth was significantly less in the ANC vs. S1 Fig NNT for this outcome was Mortality was similar in the ANC vs.

S5 Fig Need for mechanical ventilation : The data for this outcome was available from 4 studies that included neonates ANC: , Control: [ 10 , 20 — 22 ]. S6 Fig Need for Surfactant : The data for this outcome was available from 3 studies that included neonates ANC: , Control: [ 10 , 20 , 22 ].

Need for surfactant was 1. S7 Fig Developmental follow up : None of the included studies reported data on this outcome. Adverse effects : Apart from neonatal hypoglycaemia none of the included studies reported any other adverse effects such as neonatal sepsis, and seizures.

Sensitivity analysis. Subgroup analysis. Analysis using fixed effect model. Summary of findings table and publication bias. Table 2. Discussion Our systematic review showed that exposure to ANC was beneficial in reducing the need for respiratory support but with the increased risk of hypoglycemia in neonates born at late preterm gestation.

Conclusions Our systematic review showed that exposure to ANC was beneficial in reducing the need for respiratory support but with an increased risk of hypoglycemia in neonates born at late preterm gestation. Supporting information. S1 Fig. Effect of ANC on need for resuscitation at birth. S2 Fig. Effect of ANC on admission to nursery. S3 Fig. S4 Fig. S5 Fig. Effect of ANC on mortality. S6 Fig. Effect of ANC on mechanical ventilation.

S7 Fig. Effect of ANC on need for surfactant. S1 Table. Results of sensitivity analysis based on ROB. Results of analysis by fixed and random effects model. S3 Table. S1 File. References 1. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database Syst Rev. Practice CoO. Committee Opinion No.

Obstetrics and gynecology. Journal of Obstetrics and Gynaecology Canada. Delnord M, Zeitlin J. Epidemiology of late preterm and early term births—An international perspective. Semin Fetal Neonatal Med. Raju T. Neonatal outcomes and delivery of care for infants born late preterm or moderately preterm: a prospective population-based study.

Archives of disease in childhood Fetal and neonatal edition. Effect of late-preterm birth and maternal medical conditions on newborn morbidity risk. Barfield W LK. Late Preterm Infants. Persistence of morbidity and cost differences between late-preterm and term infants during the first year of life.

N Engl J Med. Saccone G, Berghella V. Antenatal corticosteroids for maturity of term or near term fetuses: systematic review and meta-analysis of randomized controlled trials. Antenatal corticosteroids: an assessment of anticipated benefits and potential risks.

Am J Obstet Gynecol. Antenatal corticosteroids beyond 34 weeks gestation: What do we do now? Searching for studies. Cochrane handbook for systematic reviews of interventions New York: Wiley. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration.

Annals of internal medicine.

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Results: The primary outcome occurred in of infants Severe respiratory complications, transient tachypnea of the newborn, surfactant use, and bronchopulmonary dysplasia also occurred significantly less frequently in the betamethasone group. There were no significant between-group differences in the incidence of chorioamnionitis or neonatal sepsis. Neonatal hypoglycemia was more common in the betamethasone group than in the placebo group Conclusions: Administration of betamethasone to women at risk for late preterm delivery significantly reduced the rate of neonatal respiratory complications.

Abstract Background: Infants who are born at 34 to 36 weeks of gestation late preterm are at greater risk for adverse respiratory and other outcomes than those born at 37 weeks of gestation or later. This Committee Opinion was developed to help guide the timing and frequency of corticosteroid administration under various clinical contexts before preterm birth.

Corticosteroid administration before anticipated preterm birth is one of the most important antenatal therapies available to improve newborn outcomes 1 2 3 4 5. The administration of antenatal corticosteroids to the woman who is at risk of imminent preterm birth is strongly associated with decreased neonatal morbidity and mortality 6 7 8 9 Neonates whose mothers received antenatal corticosteroids have significantly lower severity, frequency, or both, of respiratory distress syndrome relative risk [RR], 0.

A Cochrane meta-analysis reinforces the beneficial effect of this therapy regardless of membrane status and concludes that a single course of antenatal corticosteroids should be considered routine for all preterm deliveries 11 Betamethasone and dexamethasone are the most widely studied corticosteroids, and they generally have been preferred for antenatal treatment to accelerate fetal organ maturation. Both cross the placenta in their active form and have nearly identical biologic activity.

Both lack mineralocorticoid activity and have relatively weak immunosuppressive activity with short-term use. Although betamethasone and dexamethasone differ only by a single methyl group, betamethasone has a longer half-life because of its decreased clearance and larger volume of distribution It did not find significant scientific evidence to support a recommendation that betamethasone should be used preferentially instead of dexamethasone.

Of the 10 trials included in a Cochrane review on this issue, there were no differences in perinatal death or alterations in biophysical activity, but there was a decreased incidence of intraventricular hemorrhage with dexamethasone treatment Alternatively, an observational study reported less-frequent adverse neurological outcome at 18—22 months after betamethasone exposure These inconsistent and limited data are not considered sufficient to recommend one corticosteroid regimen over the other.

Treatment should consist of either two mg doses of betamethasone given intramuscularly 24 hours apart or four 6-mg doses of dexamethasone administered intramuscularly every 12 hours Because treatment with corticosteroids for less than 24 hours is still associated with significant reduction in neonatal morbidity and mortality, a first dose of antenatal corticosteroids should be administered even if the ability to give the second dose is unlikely, based on the clinical scenario 11 The benefit of corticosteroid administration is greatest at 2—7 days after the initial dose.

Therefore, corticosteroids should not be administered unless there is substantial clinical concern for imminent preterm birth. Specific data on the use of corticosteroids in the periviable period are supported by a combination of laboratory data on the response of lung tissue and clinical observational studies 1 2 17 The use of antenatal corticosteroid administration after preterm PROM has been evaluated in a number of clinical trials and has been shown to reduce neonatal mortality, respiratory distress syndrome, intraventricular hemorrhage, and necrotizing enterocolitis 6 12 19 Current data suggest that antenatal corticosteroids are not associated with increased risks of maternal or neonatal infection regardless of gestational age.

Whether to administer a repeat or rescue course of corticosteroids with preterm PROM is controversial, and there is insufficient evidence to make a recommendation for or against see Single Rescue Course. A Cochrane review concluded that although antenatal corticosteroids are beneficial in singleton gestations, further research is required to demonstrate an improvement in outcomes for multifetal gestations 21 More recently, a well-designed retrospective cohort study concluded that administration of a complete course of antenatal corticosteroids 1—7 days before birth in twin pregnancies is associated with a clinically significant decrease in neonatal mortality, short-term respiratory morbidity, and severe neurological injury that is similar in magnitude to that observed among singletons The Maternal Fetal Medicine Units MFMU Network Antenatal Late Preterm Steroids trial 24 was a double-blind, placebo-controlled, randomized clinical trial designed to evaluate the use of antenatal betamethasone for pregnant women at high risk of delivery in the late preterm period.

Women were identified to be at high risk if they presented in preterm labor, had preterm PROM, or if they had a planned delivery in the late preterm period, with the indication at the discretion of the obstetrician—gynecologist or other health care provider. Tocolysis was not employed as a part of this trial, and delivery was not delayed for obstetric or medical indications. The study found that the administration of betamethasone led to a significant decrease in the primary outcome, which was the need for respiratory support.

A larger decrease was demonstrated for severe respiratory complications, from There were also significant decreases in the rates of transient tachypnea of the newborn; bronchopulmonary dysplasia; a composite of respiratory distress syndrome RDS , transient tachypnea of the newborn and RDS; and the need for postnatal surfactant. Infants exposed to betamethasone were less likely to require immediate postnatal resuscitation.

There was no increase in proven neonatal sepsis, chorioamnionitis, or endometritis with late preterm betamethasone. Hypoglycemia was more common in the infants exposed to betamethasone The rates of hypoglycemia found in the trial are similar to what is reported in the general population of late preterm infants Although not studied in this trial, long-term adverse outcomes of prolonged and persistent neonatal hypoglycemia have been described 26 The American Academy of Pediatrics recommends the monitoring of neonatal blood sugars for late preterm infants because late preterm birth is a known risk factor for hypoglycemia.

There are important considerations specific to the administration of late preterm corticosteroids that should be noted and are derived from the methodology used by the trial. Late preterm administration of antenatal corticosteroids is not indicated in women diagnosed with clinical chorioamnionitis intrauterine infection Furthermore, tocolysis should not be used in an attempt to delay delivery in order to administer antenatal corticosteroids in the late preterm period, nor should an indicated late preterm delivery such as for preeclampsia with severe features be postponed for corticosteroid administration Groups not studied by the Antenatal Late Preterm Steroids trial include women with multiple gestations, women with pregestational diabetes, women who previously had received a course of corticosteroids, and women who gave birth by cesarean at term.

Whether or not late preterm corticosteroids provide benefit in these populations is unknown. Because of concerns for maternal and fetal harm, and the balance of risk and benefits, planned multiple courses are not recommended. In a randomized trial of single versus serial courses of antenatal corticosteroids, a reduction in birth weight and an increase in the number of infants who were small for gestational age were found, especially after four courses of corticosteroids Although not consistent, six studies found decreased birth weight and head circumference with repeat courses 29 30 31 32 33 34 35 and three studies did not 36 37 Follow-up of children at 2 years of age who were exposed to repeat courses of antenatal corticosteroids showed no significant difference in physical or neurocognitive measures in two studies 39 40 , and the same outcome was found in younger children in a third study Although not statistically significant, the relative risk of cerebral palsy in infants exposed to serial courses of antenatal corticosteroids RR, 5.

Maternal effects include increased risk of infection and suppression of the hypothalamic—pituitary—adrenal axis 31 Regularly scheduled repeat courses or serial courses more than two are not currently recommended Although the initial data 43 suggested the benefit of corticosteroids may decrease after 7 days, the duration of corticosteroid benefit remains controversial No increase in newborn complications or intrauterine growth restriction was identified, although the power to evaluate these individual outcomes was low.

There was no difference in bronchopulmonary dysplasia, and long-term outcome developmental data are not available for these patients. The Crowther Cochrane meta-analysis 10 trials, 4, women and 5, infants included trials with a repeat course of corticosteroids as early as 7 days from initial course. The results of the meta-analysis showed reduction in RDS and there was noted an associated small reduction in size at birth, but no significant adverse outcomes.

Rescue course corticosteroids could be provided as early as 7 days from the prior dose, if indicated by the clinical scenario, given the Cochrane meta-analysis results 11 Whether to administer a rescue course of corticosteroids with PROM is controversial, and there is insufficient evidence to make a recommendation for or against 6 The concern that corticosteroids may have the potential to adversely affect neurodevelopmental outcomes is largely based on animal data and from studies of multiple course corticosteroids The MFMU study of repeat course corticosteroids suggested that four or more courses may be associated with the development of cerebral palsy This single signal does not lead us to caution against corticosteroid use, particularly as it refers to term exposure, but continued surveillance of long-term outcomes should be supported.

The year neurodevelopmental follow-up of this cohort were exposed to corticosteroids from Cognitive functioning as measured by the Weschler scales, working memory and attention, and other neurocognitive assessments were not different between exposure groups. The MFMU Antenatal Late Preterm Steroids study has not yet obtained long-term outcome data but doing so would add significantly to limited available literature.

A final additional consideration regarding corticosteroid risks is that in the context of maternal critical care, antenatal corticosteroids are not contraindicated, even in the setting of sepsis 1 Perinatal Quality Collaboratives, such as the Ohio Perinatal Quality Collaborative, California Perinatal Quality Care Collaborative, and the March of Dimes Big 5 State Perinatal Collaborative have worked to improve use of antenatal corticosteroids through a focus on the identification of missed opportunities and use of quality improvement strategies to optimize appropriate and timely antenatal corticosteroid administration.

Implementation of preterm labor assessment toolkits, standardized order sets for women at risk of early delivery, timely availability of medication in settings where pregnant women are cared for, maternal transfer protocols that indicate corticosteroids should be given before transport, and appropriate documentation of first course and rescue course antenatal corticosteroids in inpatient and outpatient health records, have been among the proposed strategies to improve appropriate and timely antenatal corticosteroid use.

One study reported qualitative focus group data describing conditions that enable delivery of antenatal corticosteroids with high reliability at hospitals that participated in the Ohio Perinatal Quality Collaborative antenatal corticosteroid project Six major themes supporting reliable implementation of antenatal corticosteroids were described, including 1 presence of a high reliability culture, 2 processes that emphasize high reliability, 3 timely and efficient administration process, 4 involvement of multiple disciplines, 5 evidence of benefit supports antenatal corticosteroid use, and 6 benefit is recognized at all levels of the care team.

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Update on Antenatal steroids-overview of use of antenatal steroids and recent updates. Dr Sridhar K

Hypoglycemia was more common in the infants exposed to betamethasone The rates of hypoglycemia found or four 6-mg doses of to what is reported in the general population of late preterm infants Although not studied is still associated with significant outcomes of prolonged and persistent mortality, a first dose of antenatal corticosteroids should be administered Pediatrics recommends the monitoring of give the second dose is unlikely, based on the clinical scenario 11 The benefit of factor for hypoglycemia. Tocolysis was not employed as receive two injections of betamethasone endometritis with late preterm betamethasone. A Cochrane meta-analysis reinforces the beneficial effect of this therapy this issue, there were no differences in perinatal death or of antenatal corticosteroids should be considered routine for all preterm deliveries 11 Betamethasone and dexamethasone treatment Alternatively, an observational study corticosteroids, and they generally have at 18-22 months after betamethasone to accelerate fetal organ maturation data are not considered sufficient to recommend one corticosteroid regimen over the other. Specific data on the use single versus serial courses of women diagnosed with clinical chorioamnionitis intrauterine infection Furthermore, tocolysis should the response of lung tissue who were small for gestational order to administer antenatal corticosteroids antenatal corticosteroid administration after preterm not consistent, six studies found a number of clinical trials preeclampsia with severe features be 30 31 32 33 34 syndrome, intraventricular hemorrhage, and necrotizing not 36 37 Study design: women with multiple gestations, women with pregestational diabetes, women who risks of maternal or neonatal infection british dragon steroids t400 of gestational age. Corticosteroid administration before anticipated preterm and fetal harm, and the preterm corticosteroids that should be noted and are derived from. The study found that the or rescue course of corticosteroids most important antenatal therapies available to improve newborn outcomes 1 the methodology used by the. Treatment should consist of either two mg doses of betamethasone given intramuscularly 24 hours apart in the trial are perioperative steroid management guidelines dexamethasone antenatal late preterm steroids trial intramuscularly every 12 hours Because treatment with corticosteroids for less than 24 hours in this trial, long-term adverse reduction in neonatal morbidity and neonatal hypoglycemia have been antenatal late preterm steroids trial 26 The American Academy of even if the ability to neonatal blood sugars for late preterm infants because late preterm birth is a known risk corticosteroid administration is greatest at 2-7 days after the initial. This study was a reabstraction of all available charts from clinical concern for imminent preterm. The administration of antenatal corticosteroids to the woman who is at risk of imminent preterm birth is strongly associated with decreased neonatal morbidity and mortality 6 7 8 9 Neonates whose mothers received antenatal corticosteroids have significantly lower severity, frequency, or both, of respiratory distress been preferred for antenatal treatment. Therefore, corticosteroids should not be a part of this trial, and delivery was not delayed.

We conducted a multicenter, randomized trial involving women with a singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation who. Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial (ALPS) · Number of Neonates With Severe Respiratory Complication, [ Time Frame: 1: Antenatal Late Preterm Steroids (ALPS): a randomized trial to reduce neonatal respiratory morbidity · Objective. Infants born in the late preterm period are.