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Survival without severe neonatal morbidity after antenatal betamethasone dose reduction: a post hoc analysis of a randomized non-inferiority trial

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  • معلومة اضافية
    • Contributors:
      Hôpitaux Universitaires de Genève = University Hospital of Geneva Genève (HUG); Université Paris Cité (UPCité); Université de Genève = University of Geneva (UNIGE); Maladies neurodéveloppementales et neurovasculaires (NeuroDiderot (UMR_S_1141 / U1141)); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité); Centre d'Investigation Clinique 1426 (CIC 1426); Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré Paris; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Centre de Recherche des Cordeliers (CRC (UMR_S_1138 / U1138)); École Pratique des Hautes Études (EPHE); Université Paris Sciences et Lettres (PSL)-Université Paris Sciences et Lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Paris Cité (UPCité); AP-HP Hôpital universitaire Robert-Debré Paris; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Health data- and model- driven Knowledge Acquisition (HeKA); Centre Inria de Paris; Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Centre de Recherche des Cordeliers (CRC (UMR_S_1138 / U1138)); Université Paris Sciences et Lettres (PSL)-Université Paris Sciences et Lettres (PSL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Université Paris Cité (UPCité)-École Pratique des Hautes Études (EPHE); Centre Hospitalier Universitaire de Bordeaux (CHU Bordeaux); Hôpital Femme Mère Enfant CHU - HCL (HFME); Hospices Civils de Lyon (HCL); Université Claude Bernard Lyon 1 (UCBL); Université de Lyon; Hôpital Robert Debré; Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables (ECEVE (U1123 / UMR_S_1123)); Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité); Hôpital Jean Verdier AP-HP; Centre for Research in Epidemiology and Statistics; Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE); Ministère français de la Santé
    • بيانات النشر:
      CCSD
      Elsevier
    • الموضوع:
      2024
    • نبذة مختصرة :
      International audience ; BACKGROUND: Antenatal betamethasone is recommended before preterm delivery to accelerate fetal lung maturation. However, its optimal dose remains unknown. A 50% dose reduction was proposed to decrease the potential dose-related long-term neurodevelopmental side effects, including psychological development, sleep, and emotional disorders. Because noninferiority of the half dose in terms of the need for exogenous surfactant was not shown in the primary analysis, its impact on survival without major neonatal morbidity needs to be investigated. OBJECTIVE: This study aimed to investigate the impact of antenatal betamethasone dose reduction on survival of very preterm infants without severe neonatal morbidity, a factor known to have a strong correlation with long-term outcomes. STUDY DESIGN: We performed a post hoc secondary analysis of a randomized, multicenter, double-blind, placebo-controlled, noninferiority trial, testing half (11.4 mg once; n¼1620) vs full (11.4 mg twice, 24 hours apart; n¼1624) antenatal betamethasone doses in women at risk of preterm delivery. To measure survival without severe neonatal morbidity at hospital discharge among neonates born before 32 weeks of gestation, we used the definition of the French national prospective study on preterm children, EPIPAGE 2, comprising 1 of the following morbidities: grade 3 to 4 intraventricular hemorrhage, cystic periventricular leukomalacia, necrotizing enterocolitis stage !2, retinopathy of prematurity requiring anti-vascular endothelial growth factor therapy or laser, and moderate-to-severe bronchopulmonary dysplasia. RESULTS: After exclusion of women who withdrew consent or had pregnancy termination and of participants lost to follow-up (8 in the halfdose and 10 in the full-dose group), the rate of survival without severe neonatal morbidity among neonates born before 32 weeks of gestation was 300 of 451 (66.5%) and 304 of 462 (65.8%) in the half-dose and fulldose group, respectively (risk difference, þ0.7%; 95% confidence ...
    • Relation:
      info:eu-repo/semantics/altIdentifier/pmid/38341166; PUBMED: 38341166; WOS: 001320185300001
    • الرقم المعرف:
      10.1016/j.ajog.2024.02.002
    • الدخول الالكتروني :
      https://hal.univ-lorraine.fr/hal-04689204
      https://hal.univ-lorraine.fr/hal-04689204v1/document
      https://hal.univ-lorraine.fr/hal-04689204v1/file/Survival%20without%20severe%20neonatal.JMH.pdf
      https://doi.org/10.1016/j.ajog.2024.02.002
    • Rights:
      http://creativecommons.org/licenses/by/ ; info:eu-repo/semantics/OpenAccess
    • الرقم المعرف:
      edsbas.EF4180B