Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants <33 Weeks: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Hemoglobin during NICU course
研究概览
简要总结
Anemia in preterm neonates is a significant problem encountered frequently in the neonatal intensive care unit. Most preterm neonates born at less than 33 weeks gestation will require at least one blood transfusion during their hospital course and many will require repeated transfusions. Blood transfusions, albeit necessary, carry increased risk of viral infections and transfusion reactions as well as increase the cost of healthcare. The umbilical cord and placenta harbor up to 40% of blood available during fetal life. The current standard of care is immediate umbilical cord clamping. The investigators are performing a randomized controlled trial comparing immediate cord clamping to milking the umbilical cord prior to clamping in neonate born preterm less than 33 weeks gestation. The investigators hypothesize that milking the umbilical cord will demonstrate the same benefits as delayed cord clamping, without delaying neonatal resuscitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates delivered between 24 0/7 and 32 6/7
- •Mother carrying a fetus between 24-32 6/7 weeks estimated gestational age
- •Written parental consent
排除标准
- •Multiple gestation pregnancies (twins or higher order multiples)
- •Rh or other antibody sensitization
- •Hydrops fetalis
- •Known major congenital abnormality
- •Suspected abruptio placentae
研究组 & 干预措施
Immediate umbilical cord clamping
The umbilical cord will be clamped immediately after delivery.
干预措施: Immediate cord clamping (Procedure)
Cord milking group
The umbilical cord will be "milked" in direction towards neonate 4 times over the course of 10 minutes.
干预措施: Milking group (Procedure)
结局指标
主要结局
Hemoglobin during NICU course
时间窗: within 24 hours of birth and through NICU stay
次要结局
- Cord blood pH(within 1 hour of birth)
- Maximum serum bilirubin(1 month)
- Blood Sugar upon admission to NICU(within 1 hour of birth)
- Days requiring ventilation(2 months)
- Neonatal death(6 months)
- 1-min Apgar(at 1 minute of life)
- 5 min Apgar(at 5 minutes of life)
- Temperature on admission to NICU(within 1 hour of birth)
- Blood pressure upon admission to NICU(within 1 hour of birth)
- Number of volume challenges in first 24 hours of life(at 24 hours of birth)
- Length of hospital stay(6 months)
- Intraventricular hemorrhage(6 months)
- Number and volume of blood transfusions(10 units)
- duration of phototherapy(1 month)