Effect of Umbilical Cord Clamping Method on Peripheral Blood Stem Cell Counts in Preterm Newborns: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Neonatal Hemoglobin Level
研究概览
简要总结
This study evaluates the effect of different umbilical cord clamping methods on peripheral blood hematopoietic stem cell counts in preterm newborns.
Preterm infants were randomly assigned to different umbilical cord clamping strategies as part of routine obstetric care. Peripheral blood samples were collected after birth to assess stem cell concentrations.
The aim of the study was to determine whether physiological cord management strategies could influence early hematologic adaptation in preterm infants. The study was conducted using standard clinical procedures without additional intervention beyond routine care.
详细描述
This prospective randomized study was conducted to investigate the impact of different umbilical cord clamping methods on peripheral blood hematopoietic stem cell counts in preterm newborns.
Eligible preterm infants were randomly allocated to one of the predefined umbilical cord clamping strategies according to the study protocol. All procedures were performed as part of standard obstetric and neonatal care, and no experimental intervention outside routine clinical practice was applied.
Peripheral blood samples were obtained following delivery, and hematopoietic stem cell concentrations were analyzed using standard laboratory methods. The primary outcome was the comparison of stem cell counts between the different cord clamping groups.
The study was initiated and completed in 2015, prior to mandatory prospective clinical trial registration requirements. Ethical approval was obtained from the relevant institutional ethics committee, and informed consent was obtained from parents or legal guardians before participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Outcome assessors were blinded to group allocation.
入排标准
- 年龄范围
- 0 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm neonates born between 28+0 and 36+6 weeks of gestation.
- •Infants born at a single tertiary referral center.
- •Written informed consent obtained from parents prior to delivery.
排除标准
- •Major fetal congenital anomalies.
- •Perinatal asphyxia.
- •Requirement for advanced neonatal resuscitation at birth.
- •Undetermined gestational age.
- •Gestational age less than 28 weeks.
研究组 & 干预措施
Immediate Cord Clamping (ICC)
Umbilical cord clamped within 30 seconds after birth.
干预措施: Immediate Cord Clamping (Procedure)
Delayed Cord Clamping (DCC)
Umbilical cord clamped 60 seconds after birth.
干预措施: Delayed Cord Clamping (Procedure)
Umbilical Cord Milking (UCM)
Umbilical cord milked toward the infant before clamping.
干预措施: Umbilical Cord Milking (Procedure)
结局指标
主要结局
Neonatal Hemoglobin Level
时间窗: Within first 24 hours after birth
Comparison of neonatal hemoglobin levels among immediate cord clamping, delayed cord clamping, and umbilical cord milking groups.
次要结局
未报告次要终点
研究者
Era Tufan Benli
Principal Investigator
Dr. Sami Ulus Children's Hospital