Outcomes of preterm neonates less than equal to 32 weeks of gestational age with intact cord resuscitation a prospective observational analytical study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Decreased need of invasive or non invasive respiratory support.
研究概览
简要总结
This randomized controlled trial (RCT) aims to evaluate the outcomes of preterm neonates (<32 weeks gestation) undergoing intact cord resuscitation (ICR) compared to the current standard practice of immediate cord clamping during resuscitation. The study is being conducted in the Labour Room and EDEN OT of Medical College and Hospital, Kolkata. Eligible neonates are randomized into intervention and control groups. Primary outcomes include survival and short-term neonatal morbidities (e.g., respiratory distress, need for ventilation, intraventricular hemorrhage). Secondary outcomes assess adaptation parameters and early complications. The trial is designed to generate evidence on the feasibility and benefits of ICR in extremely preterm neonates, with the goal of improving neonatal survival and reducing complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 90.00 Day(s)（—）
- 性别
- All
入选标准
- •Gestational age less than equal to 32 weeks .
- •Inborn neonates delivered at MCH, Kolkata.
- •Neonates receiving resuscitation with intact cord.
排除标准
- •Maternal HIV infection
- •Maternal Hepatitis B infection
- •Rh-negative pregnancy
- •Antepartum hemorrhage, including: a.
- •Placenta previa b.
- •Abruptio placentae
- •Mothers who do not provide informed consent
- •Major congenital anomalies
- •Cord complications such as: a.
- •Cord prolapse
- •True knot of the cord
- •Outborn neonates
- •Hydrops fetalis.
结局指标
主要结局
Decreased need of invasive or non invasive respiratory support.
时间窗: 3 months
次要结局
- 1.Decreased incidence of retinopathy of prematurity.(2.Decreased incidence of intraventricular hemorrhage.)
研究者
Dr Ayan Das
Medical College and Hospital Kolkata