Clinical monitoring based bilirubin assessment versus routine bilirubin assessment in neonates with ABO incompatibility.A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Need for phototherapy
研究概览
简要总结
This study is a randomized,open labelled,parallel group study comparing outcomes in newborns with clinical assessment of jaundice and regular monitoring of bilirubin levels in direct coombs test(DCT) positive infants so that if comparable outcomes are seen in visually inspected infants number of pricks can be decreased.The findings from this study have the potential to eliminate frequent sampling for monitoring of bilirubin levels and can help to alleviate parental anxiety.It gives us a clear picture on the recommended frequency of monitoring without causing any adverse events like significant hyperbilirubinemia causing neurological dysfunction or exchange transfusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Newborn babies ≥35 weeks of gestation who are direct coomb’s test positive at birth due to ABO incompatibility.
排除标准
- •1.Neonates less than 35 weeks gestation , Neonates with major congenital malformations or syndromic features,Neonates who require extensive resuscitation at birth,Neonates who require immediate NICU stay with advanced life support, Neonates who have features of hydrops fetalis on antenatal scans & required Intrauterine Transfusions, Neonates whose parents haven’t given consent for including in the study ,Neonates with perinatal asphyxia,acute cord vascular accident,Severe SGA neonates.
结局指标
主要结局
Need for phototherapy
时间窗: 1 year
次要结局
- Neonates with sepsis
- Neonates with peak bilirubin levels reaching close to exchange transfusion zone(1 year)
- Total duration of phototherapy(1 year)
- Neonates requiring IVIG therapy(1 year)
- Neonates requiring exchange transfusion(1 year)
- Length of hospital stay(1 year)
- Rebound hyperbilirubinemia in neonates treated with phototherapy(1 year)
- Readmission to hospital(1 year)
研究者
Ameyaarjun Arumugam
CHETTINAD HOSPITAL AND RESEARCH INSTITUTE