跳至主要内容
临床试验/NCT04869709
NCT04869709Unknown4 期

Timing of Late Preterm Corticosteroid Administration and Neonatal Hypoglycemia

University of Southern California1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2021年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
210
试验地点
1
主要终点
Neonatal Glucose Concentration

研究概览

简要总结

This is a prospective randomized controlled trial investigating the timing of betamethasone administration in late preterm infants in relation to delivery and impact on neonatal hypoglycemia. Previous data has shown that neonatal hypoglycemia is increased in late preterm infants that were exposed to antenatal corticosteroids. The investigators hypothesize that the timing of steroid administration may impact the development of neonatal hypoglycemia.

详细描述

The use of antenatal corticosteroids for women at risk for preterm delivery has become widely adopted as standard of care. The American College of Obstetrics and Gynecologists (ACOG) officially recommends the use of corticosteroids for pregnant women between 24 and 34 weeks of gestation at risk of delivery within 7 days. Since publication of the ALPS trial, the Society of Maternal Fetal Medicine (SMFM) published guidelines supporting the use of late preterm steroids for singleton pregnancies between 34 weeks 0 days and 36 weeks 6 days who are at high risk of preterm birth within 7 days.

A secondary finding of the ALPS trial included the observation that the administration of antenatal betamethasone significantly increased the rate of neonatal hypoglycemia; the authors emphasized that while the long-term risks associated with neonatal hypoglycemia are not fully known, significant hypoglycemia is associated with poor neurodevelopmental outcome.

The optimal interval for administering late preterm steroids before delivery to minimize the risks of hypoglycemia while maximizing the benefits of fetal lung maturity has not been identified. The proposed research study will further investigate this question by randomizing patients to receive late preterm corticosteroids 2 days before delivery versus 7 days before delivery in order to determine if the rates and severity of neonatal hypoglycemia are different.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancy
  • Gestational age 34 0/7 weeks to 36 5/7 weeks
  • Planned delivery in late preterm period

排除标准

  • Prior course of betamethasone during pregnancy
  • Twin gestation
  • Fetal demise
  • Major fetal anomaly
  • Maternal contraindication to betamethasone
  • Pregestational diabetes
  • Expected delivery within 12 hours of randomization

研究组 & 干预措施

Late Preterm Steroids 2 Days

Active Comparator

干预措施: Betamethasone Sodium Phosphate (Drug)

Late Preterm Steroids 7 Days

Active Comparator

干预措施: Betamethasone Sodium Phosphate (Drug)

结局指标

主要结局

Neonatal Glucose Concentration

时间窗: Delivery to 72 hours of life

Glucose reported in mg/dL; Hypoglycemia defined as concentration \< 40 mg/dL

次要结局

  • Stillbirth(From administration of the intervention (betamethasone) to delivery)
  • Neonatal death(Delivery to 30 days of life)
  • Respiratory distress syndrome (RDS)(Delivery to 72 hours of life)
  • Transient Tachypnea of the Newborn(Delivery to 72 hours of life)
  • Length of Hospital Stay(Delivery to discharge from hospital)
  • Use of CPAP or High Flow Nasal Cannula(Delivery to 72 hours of life)
  • Need for supplemental oxygen(Delivery to 72 hours of life)
  • Use of ECMO(Delivery to 72 hours of life)
  • Neonatal pneumonia(Delivery to 72 hours of life)
  • Need for surfactant administration(Delivery to 72 hours of life)
  • Use of mechanical ventilation(Delivery to 72 hours of life)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Sasso

Assistant Professor of Obstetrics & Gynecology

University of Southern California

研究点 (1)

Loading locations...

相似试验