Efficacy and Safety of Postnatal Betamethasone for Respiratory Weaning in Extremely Low Gestational Age Neonates (ELGANs) in a Prospective Cohort - Proof of Concept Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The rate of successful respiratory weaning
研究概览
简要总结
The goal of this study is to determine if giving a steroid medication (specifically, betamethasone) after birth can help extremely premature babies (born before 28 weeks) come off breathing machines safely and reduce their risk of chronic lung disease associated with prematurity. Only babies who meet treatment criteria will receive this medication. Babies who do not meet treatment criteria will not receive medication.
The main questions it aims to answer are:
- Does betamethasone make it easier for babies to come off a breathing machine?
- Does betamethasone cause any harmful side effects on growth or development?
All babies in this study will:
- Receive standard NICU care, with or without betamethasone
- Have their progress, growth, and development followed over time
详细描述
Babies born extremely early (before 28 weeks of pregnancy) often have very immature lungs and usually need a breathing machine to stay alive. Many of these babies develop a chronic lung disease associated with prematurity called bronchopulmonary dysplasia, which can cause breathing problems that may last for months or years.
Doctors sometimes use steroid medications after birth to help reduce lung inflammation, make breathing easier, and help babies come off the ventilator sooner. One of these medications is betamethasone. Betamethasone is already commonly given to mothers before preterm birth to help babies' lungs mature.
At our hospital, betamethasone has been given after birth for more than 20 years to help some premature babies breathe better and come off a breathing machine. This study will help us learn how well this medicine works and possible side effects.
All babies born before 28 weeks gestation will be approached for enrollment in this study. Babies with lung disease severe enough according to predetermined criteria will receive betamethasone. Babies who dont have severe lung disease will not receive betamethasone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 28 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born at less than 28 weeks gestation age
- •Admitted to WMC NICU prior to day of life 35
排除标准
- •Infants with major congenital or chromosomal abnormalities.
- •Death prior to DOL
- •Previous exposure to postnatal steroids
研究组 & 干预措施
Betamethasone arm
Infants who meet clinical criteria will receive postnatal betamethasone
干预措施: Betamethasone (Drug)
Comparison
Infants who do not meet criteria to receive treatment
结局指标
主要结局
The rate of successful respiratory weaning
时间窗: From initiation of treatment until 7 days after treatment completion
* Defined by a 20% reduction from baseline in mean airway pressure or FiO2 if patient remains intubated * or successful extubation and maintenance of extubation for 7 days after betamethasone completion
次要结局
- The incidence of adverse events(During betamethasone administration period (5 days))
- The incidence of adverse events(From the time of initiation of betamethasone until the time of NICU discharge or 52 weeks of age, whichever comes first)
- The incidence of adverse events(During betamethasone administration period and up to 72 hours after completion of betamethasone administration)
- The incidence of mortbidities associated with extreme prematurity(From admission until the time of NICU discharge or 52 weeks of age, whichever comes first)
- Anthropometric measurements(From discharge to 24 months corrected age)
- Neurodevelopmental outcomes(at 24 months corrected age)
- Bronchopulmonary dysplasia diagnosis(at 36 weeks corrected age)
研究者
Khang Nguyen
MD
New York Medical College