Effect of Delayed Cord Clamping 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
- 2
- 主要终点
- Peripheral venous CD34 at admission
研究概览
简要总结
To investigate the effect of delayed cord clamping (DCC) on hematopoietic progenitor cells (HPCs), hematological parameters including haemoglobin concentration and hematocrit value in premature infants (34 weeks gestational age or less) with placental insufficiency.We hypothesized that preterm infants with placental insufficiency underwent DDC could have better hematologic parameters and hematopoietic progenitor cells compared to immediate cord clamping.
详细描述
• A prospective randomized controlled study will be performed on preterm infants 34 weeks gestational age or less with placental insufficiency, and those without placental insufficiency where DCC will be performed in both groups. A third group of preterm with placental insufficiency and immediate cord clamping will be performed as a control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Minutes 至 1 Minute（Child）
- 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 minutes of life and CD34 will be assessed by flow cytometry.
次要结局
- Hemoglobin at 2 months(2 months of infants' life)
- Intraventricular hemorrhage(first 28 days of life)
- Retinopathy of prematurity(first 28 days of life)
- Admission hemoglobin(first 24 hours of infants' life)
- Polycythemia(first 28 days of life)
- Necrotizing enterocolitis(first 28 days of life)
- Duration of oxygen therapy(first 28 days of life)
- Bronchopulmonary dysplasia(first 70 days of life)
- Need for nasal CPAP(first 28 days of life)
- Admission platelets(first 24 hours of infants' life)
- Culture proven sepsis(first 28 days of life)
- Need for mechanical ventilation(first 28 days of life)
- Need for inotropes(first 28 days of life)
- Need for packed RBCs transfusion(first 28 days of life)
- Admission WBCs(first 24 hours of infants' life)
- Phototherapy requirements(first 28 days of life)
研究者
Nehad Nasef
Professor of pediatrics/Neonatology
Mansoura University Children Hospital