Influence of Umbilical Cord Clamping Time in the Newborn, Secondary Neonatal Morbidity and Iron Deposits in the Neonate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 195
- 试验地点
- 2
- 主要终点
- haemoglobin
研究概览
简要总结
This study compares two umbilical cord clamping times; the early one, up to a minute (ECC) and the late or delayed one, when the cord stop beating (DCC). The additional blood volume delivered to the newborn from the placenta - placental transference - by delaying umbilical cord ligation, increases the contribution of neonatal iron with increased iron stores in the infant, without increasing neonatal morbidity.
详细描述
It is an intervention study without drugs administration with a longitudinal, prospective comparison and correlational design.
Patients are recruited by simple random sampling to one of the two intervention groups:
Group 1-ECC: Early clamping of the umbilical cord (before the first minute of life).
Group 2-DCC: Delayed clamping of the umbilical cord (when it stops beating).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 35 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •neonates with a gestational age of 35 to 42 weeks and born through normal vaginal delivery.
排除标准
- •monochorionic multiples
- •incarcerated mothers
- •placenta previa
- •concern for abruptions
- •Rh sensitization
- •congenital anomalies
- •the obstetrician declining to perform the intervention
研究组 & 干预措施
Group 1: ECC
In the ECC group, the cord was clamped immediately after delivery, before the first minute of life.
Blood test 6hours after clamping Blood test 24hours after clamping Blood test 48hours after clamping Blood test 28days after clamping
干预措施: ECC (Procedure)
Group 1: ECC
In the ECC group, the cord was clamped immediately after delivery, before the first minute of life.
Blood test 6hours after clamping Blood test 24hours after clamping Blood test 48hours after clamping Blood test 28days after clamping
干预措施: Blood Test 6hours (Procedure)
Group 1: ECC
In the ECC group, the cord was clamped immediately after delivery, before the first minute of life.
Blood test 6hours after clamping Blood test 24hours after clamping Blood test 48hours after clamping Blood test 28days after clamping
干预措施: Blood Test 24hours (Procedure)
Group 1: ECC
In the ECC group, the cord was clamped immediately after delivery, before the first minute of life.
Blood test 6hours after clamping Blood test 24hours after clamping Blood test 48hours after clamping Blood test 28days after clamping
干预措施: Blood Test 48hours (Procedure)
Group 1: ECC
In the ECC group, the cord was clamped immediately after delivery, before the first minute of life.
Blood test 6hours after clamping Blood test 24hours after clamping Blood test 48hours after clamping Blood test 28days after clamping
干预措施: Blood Test 28days (Procedure)
Group 2: DCC
In the DCC group, the cord was clamped when it stops beating. Blood test 6hours after clamping Blood test 24hours after clamping Blood test 48hours after clamping Blood test 28days after clamping
干预措施: DCC (Procedure)
Group 2: DCC
In the DCC group, the cord was clamped when it stops beating. Blood test 6hours after clamping Blood test 24hours after clamping Blood test 48hours after clamping Blood test 28days after clamping
干预措施: Blood Test 6hours (Procedure)
Group 2: DCC
In the DCC group, the cord was clamped when it stops beating. Blood test 6hours after clamping Blood test 24hours after clamping Blood test 48hours after clamping Blood test 28days after clamping
干预措施: Blood Test 24hours (Procedure)
Group 2: DCC
In the DCC group, the cord was clamped when it stops beating. Blood test 6hours after clamping Blood test 24hours after clamping Blood test 48hours after clamping Blood test 28days after clamping
干预措施: Blood Test 48hours (Procedure)
Group 2: DCC
In the DCC group, the cord was clamped when it stops beating. Blood test 6hours after clamping Blood test 24hours after clamping Blood test 48hours after clamping Blood test 28days after clamping
干预措施: Blood Test 28days (Procedure)
结局指标
主要结局
haemoglobin
时间窗: 28 days
haemoglobin level
haematocrit
时间窗: 28 days
haematocrit level
次要结局
- serum ferritin(28days)
- bilirubin(28days)
研究者
Pascual Gregori Roig
Adjunct Pediatrician of University Hospital of La Plana (Spain)
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana