Comparison of Neonatal Outcomes With Two Dexamethasone Regimens (12 mg vs 6 mg Every 12 Hours) for Fetal Lung Maturation in Preterm Birth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Duration of Mechanical Ventilation Support
研究概览
简要总结
The goal of this observational study was to compare two doses of dexamethasone given to pregnant women at risk of preterm birth. Dexamethasone is a medicine used before birth to help a baby's lungs mature.
This study looked at preterm babies born between 26 and 36 weeks of pregnancy. Researchers compared babies whose mothers received dexamethasone 12 mg every 12 hours for 48 hours with babies whose mothers received dexamethasone 6 mg every 12 hours for 48 hours.
The main questions this study aimed to answer were:
- Did the higher dose of dexamethasone help preterm babies need breathing support for a shorter time?
- Did the higher dose help shorten the babies' stay in the Neonatal Intensive Care Unit (NICU)?
- Was the higher dose as safe as the lower dose for babies and mothers?
Researchers reviewed medical records from Stella Maris Women's and Children's Hospital from January 2018 to January 2023. They looked at neonatal outcomes, including breathing support, respiratory distress syndrome, length of NICU stay, low blood sugar in babies, infection in mothers, and developmental problems at 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 26 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born to mothers with gestational age between 26 and 36 weeks
- •Infants whose mothers received antenatal dexamethasone for fetal lung maturation
- •Infants with complete medical records
- •Singleton or multiple gestations, including twins, triplets, or quadruplets
排除标准
- •Stillbirths
- •Term infants
- •Preterm infants with known congenital anomalies
- •Preterm infants with known chromosomal abnormalities
- •Cases with preterm premature rupture of membranes
研究组 & 干预措施
Dexamethasone 12 mg Every 12 Hours
干预措施: Dexamethasone 12 mg Every 12 Hours (Drug)
Dexamethasone 6 mg Every 12 Hours
干预措施: Dexamethasone 6 mg Every 12 Hours (Drug)
结局指标
主要结局
Duration of Mechanical Ventilation Support
时间窗: From initiation of mechanical ventilation until discontinuation of mechanical ventilation, assessed up to NICU discharge or 12 weeks after birth, whichever occurred first
Number of days preterm infants required mechanical ventilation support after birth. This outcome was compared between infants whose mothers received dexamethasone 12 mg every 12 hours and infants whose mothers received dexamethasone 6 mg every 12 hours.
次要结局
- Length of Stay in the Neonatal Intensive Care Unit (LOS-NICU)(From NICU admission until NICU discharge, assessed up to 12 weeks after birth)
- Need for Respiratory Support(From birth until NICU discharge, assessed up to 12 weeks after birth)
- Neonatal Respiratory Distress Syndrome(From birth until NICU discharge, assessed up to 12 weeks after birth)
- Neonatal Sepsis(From birth until NICU discharge, assessed up to 12 weeks after birth)
- Necrotizing Enterocolitis(From birth until NICU discharge, assessed up to 12 weeks after birth)
- Neonatal Intraventricular Hemorrhage(From birth until NICU discharge, assessed up to 12 weeks after birth)
- Neonatal Hypoglycemia(From birth until NICU discharge, assessed up to 12 weeks after birth)
- Neurodevelopmental Disorders at 24 Months(At 24 months of age after birth)
- Maternal Infection(From first dose of antenatal dexamethasone until maternal hospital discharge, assessed up to 7 days after delivery)
研究者
Binarwan Halim
Associate Professor
Stella Maris Women and Children Hospital