The Effect of Umbilical Cord Milking on Hemodynamic Status of Preterm Infants: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 4-6 hours after birth.
研究概览
简要总结
Very preterm babies frequently develop problems with their blood circulation during the first few days after birth. These circulation problems could affect the oxygen and blood flow to their brain and lead to effects such as bleeding in the head or delayed developmental milestones later in life. Currently the care for such problems may include transfusion of intravenous fluids or blood to the baby and/or giving the baby medications that can help circulation.
The current practice at the delivery of these babies is to immediately clamp their umbilical cords after birth. Recent research studies have shown that giving more of the baby's own blood to them at birth by delayed cord clamping (waiting for clamping the cord for about 30-90 seconds) or by milking the cord, may reduce the number of blood transfusions that these babies may need later on. It may also improve their initial blood pressure and reduce the chances of bleeding in their heads.
More research is needed to prove if either delayed cord clamping or milking the cord at birth will be better in terms of improving these babies' health.
The aim of this study is to find out if adding some blood to these babies' circulation, through milking the cord at birth, could prevent or reduce the possible problems with blood circulation and the reduced blood flow to the brain that some of these babies may have after birth.
The investigators will also investigate if milking the cord at birth could improve their long-term developmental outcome.
Hypothesis: In preterm infants less than 31 weeks' gestation, milking the umbilical cord 3 times prior to clamping, compared to immediate clamping after birth will improve systemic blood flow (as assessed by improving superior vena cava flow measured by heart ultrasound in the first 24 hours after birth)
详细描述
Eligible mothers will be randomized prior to delivery once preterm labour is established (cervical dilatation > 4cm and preterm birth is considered inevitable or delivery is indicated for maternal or fetal indications) to either milking of the umbilical cord of their infants (intervention group) or to clamp the cord as per standard practice (currently it is the immediate cord clamping) after birth (control group). Randomization will be done in variable block sizes and will be concealed by using opaque envelopes prepared ahead of time from a randomization table. Envelopes will be opened before the time of delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 24 Weeks 至 31 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants < 31 weeks' gestation if their mothers fulfill the following inclusion criteria:
- •admitted to the hospital for at least 2 hours before delivery in preterm labor (cervical dilatation >2 cm or having premature rupture of membranes) or if a decision to induce labour has been made by treating physician for a maternal or fetal indications).
- •at 24+0 weeks - 30+6/7 weeks gestation (by best estimate based on date of last menstrual period or early ultrasound)
排除标准
- •monochorionic twin or any higher order multiple pregnancy
- •major fetal congenital or chromosomal anomalies
- •significant placental abruption
- •fetal anemia/transfusion
- •Rh isoimmunization
- •intent to withhold or withdraw treatment of the infant
结局指标
主要结局
Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 4-6 hours after birth.
时间窗: at 4-6 hours of age
次要结局
- Intraventricular hemorrhage (IVH)(during first 2 weeks of life)
- Neurodevelopmental outcome(At 36 months of age)
- low SVC flow (< 40 ml/kg/min), as assessed by echocardiography(at 4-6 and 10-12 hours of age)
- Hyperbilirubinemia and peak bilirubin level recording(during first 2 weeks of age)
- Hypotension(during the first 48 hours of life)
- Number of blood transfusions during hospital stay(at 40 weeks of corrected gestational age)
- Systemic blood flow as reflected by mean SVC flow measured by echocardiographic study at 10-12 hours after birth.(at 10-12 hours of age)
研究者
Walid El-Naggar
Primary Investigator
IWK Health Centre