BACKGROUND AND PURPOSE:Prenatal corticosteroids have been used in fetuses with congenital diaphragmatic hernia (CDH). We tested the utility of steroids by 2 methods. METHODS:Mothers carrying fetuses with CDH were randomized to 3 weekly doses of betamethasone or placebo starting at 34 weeks. Patients were followed until death or discharge. In a separate cohort study, the CDH Registry was used to compare infants who received prenatal steroids to those who had not. RESULTS:Thirty-four patients were enrolled at 7 centers, with 32 completing the trial. There were 15 placebo and 17 steroid patients. There was no difference in survival, length of stay, duration of ventilation, or oxygen use at 30 days. For the cohort study, we looked at infants older than 34 weeks who were born after October 2000 when data on prenatal steroids were collected. There were 1093 patients; 390 were evaluable, with 56 receiving steroids. There was no difference in survival, length of stay, ventilator days, or oxygen use at 30 days. CONCLUSION: Neither the trial nor the CDH Registry suggest that late prenatal corticosteroids benefit fetuses with CDH. More than 1700 mothers and fetuses would need to be enrolled in a trial to show a 10% improvement in survival. It is unlikely that late steroids offer benefit to most fetuses with CDH.
RCT Entities:
BACKGROUND AND PURPOSE: Prenatal corticosteroids have been used in fetuses with congenital diaphragmatic hernia (CDH). We tested the utility of steroids by 2 methods. METHODS: Mothers carrying fetuses with CDH were randomized to 3 weekly doses of betamethasone or placebo starting at 34 weeks. Patients were followed until death or discharge. In a separate cohort study, the CDH Registry was used to compare infants who received prenatal steroids to those who had not. RESULTS: Thirty-four patients were enrolled at 7 centers, with 32 completing the trial. There were 15 placebo and 17 steroidpatients. There was no difference in survival, length of stay, duration of ventilation, or oxygen use at 30 days. For the cohort study, we looked at infants older than 34 weeks who were born after October 2000 when data on prenatal steroids were collected. There were 1093 patients; 390 were evaluable, with 56 receiving steroids. There was no difference in survival, length of stay, ventilator days, or oxygen use at 30 days. CONCLUSION: Neither the trial nor the CDH Registry suggest that late prenatal corticosteroids benefit fetuses with CDH. More than 1700 mothers and fetuses would need to be enrolled in a trial to show a 10% improvement in survival. It is unlikely that late steroids offer benefit to most fetuses with CDH.
Authors: Carmen Mesas Burgos; Erik G Pearson; Marcus Davey; John Riley; Huimin Jia; Pablo Laje; Alan W Flake; William H Peranteau Journal: Pediatr Res Date: 2016-07-04 Impact factor: 3.756
Authors: Steffi Mayer; Philipp Klaritsch; Lourenço Sbragia; Jaan Toelen; Holger Till; Jan A Deprest Journal: Pediatr Surg Int Date: 2008-12 Impact factor: 1.827
Authors: Olivier Boucherat; Alexandra Benachi; Bernadette Chailley-Heu; Marie-Laure Franco-Montoya; Caroline Elie; Jelena Martinovic; Jacques R Bourbon Journal: PLoS Med Date: 2007-07-31 Impact factor: 11.069