Impact of Umbilical Cord Milking in Preterm Neonates With Placental Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Peripheral venous CD34 at admission
研究概览
简要总结
To investigate the effect of umbilical cord milking (UCM) on peripheral hematologic parameters including hematopoietic progenitor cells in premature infants ≤ 34 weeks gestational age with placental insufficiency. We hypothesize that UCM would enhance peripheral CD34 concentration, hemoglobin and reduce prematurity complications like NEC and IVH in preterm infant ≤ 34 week gestational age with placental insufficiency.
详细描述
A pilot prospective randomized controlled study will be conducted among 3 groups, all of them are preterm less than 34 weeks gestational age, in the first group umbilical cord milking will be done for preterm infant with placental insufficiency. Two control groups are present, in the first one umbilical cord milking will be done for preterm infants without placental insufficiency (Insufficiency vs. no insufficiency), another group of immediate cord clamping for preterm infants with placental insufficiency will be added (milking vs. no milking), 30 cases will be recruited in each group.
Umbilical cord milking (UCM) is typically performed by placing the infant below the level of the placenta. The cord is held at 20-25 cm distance from the baby and milked vigorously towards the umbilicus for 3 times at a speed of 10 cm/sec. After completion, the cord is clamped, and the neonate is handed to the resuscitation team.
One milliliter of fetal blood will be taken from peripheral venous blood in the first 30 min of life and CD34 will be assessed by flow cytometry. Secondary outcomes will be documented during NICU stay that include admission CBC, peak bilirubin concentrations, CBC after 2 months, neonatal morbidity such as sepsis, bronchopulmonary dysplasia, necrotizing enterocolitis, retinopathy of prematurity and polycythemia, therapeutic interventions such as need for inotropes, nasal CPAP, mechanical ventilation and phototherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Minutes 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm neonates < 34 weeks gestational age
排除标准
- •Vaginal bleeding due to placental abruption or tears
- •Multiple pregnancies
- •Suspected major fetal anomalies
- •Suspected chromosomal aberration
- •Maternal drug abuse
- •Hydrops fetalis
- •preterm who needed major resuscitative measures
结局指标
主要结局
Peripheral venous CD34 at admission
时间窗: first 24 hours of infants' life
One milliliter of fetal blood will be taken from peripheral venous blood in the first 30 min of life and CD34 will be assessed by flow cytometry.
次要结局
- Polycythemia(first 28 days of life)
- Necrotizing enterocolitis(first 28 days of life)
- Admission WBCs(first 24 hours of infants' life)
- Phototherapy requirements(first 28 days of life)
- Duration of oxygen therapy(first 70 days of life)
- Hemoglobin at 2 months(2 months after umbilical cord milking)
- Need for packed RBCs transfusion(first 28 days of life)
- Retinopathy of prematurity(first 28 days of life)
- Admission hemoglobin(first 24 hours of infants' life)
- Admission platelets(first 24 hours of infants' life)
- Need for nasal CPAP(first 28 days of life)
- Need for mechanical ventilation(first 28 days of life)
- Need for inotropes(first 28 days of life)
- Culture proven sepsis(first 28 days of life)
- Intraventricular hemorrhage(first 28 days of life)
- Bronchopulmonary dysplasia(first 70 days of life)
研究者
Nehad Nasef
Professor of pediatrics/Neonatology
Mansoura University Children Hospital