Efficacy and Safety of Deferred Umbilical Cord Clamping Compared to Umbilical CordMilking in Preterm Infants: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Intraventricular haemorrhage
研究概览
简要总结
For preterm infants, deferred cord clamping has been shown to improve both short term and long-term neonatal outcomes without an established harm for both the mother and her infant.The interference with resuscitative measures for the neonate or the mother is a risk that continued to hamper the implementation of delayed cord clamping in many centers around the world.For that reason, the evidence now is seeking a time-honored, yet not adopted method of placental transfusion that involves milking of the umbilical cord.
详细描述
Contrary to delayed cord clamping, milking of the umbilical cord is done at a faster rate and in shorter time.Recent evidence has demonstrated the efficacy and safety of umbilical cord milking for both term and preterm infants.A newer evidence comparing delayed cord clamping to umbilical cord milking in preterm infants demonstrated a higher initial hemoglobin, blood pressure and systemic blood flow in preterm infants allocated to the umbilical cord milking arm.However, concerns have been raised with regard to rapid infusion of large volume of blood in relatively shorter time predisposing to hyperperfusion injury including intraventricular hemorrhage. This is particularly problematic for preterm neonates as they are at higher risk of neurological injury. It has, though, advantage of shorter timeframe allowing for effective resuscitation of preterm neonates to start as soon as possible. Thus, with countering advantages and disadvantages, the practice has not been adopted at most places. The authors planned to conduct a randomized clinical trail to compare the efficacy and safety of umbilical cord milking to deferred cord clamping in preterm infants less than 32 weeks gestation.
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 (Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants < 32 weeks gestation confirmed by first trimester US
排除标准
- •Any proven or suspected congenital or chromosomal abnormalities
- •Placenta previa or abruption
- •Cord prolapse
- •Known Rh sensitization
- •Fetal hydrops
- •Monochorionic multiples
结局指标
主要结局
Intraventricular haemorrhage
时间窗: twenty eight days
Any IVH diagnosed by cranial ultrasound
次要结局
- Mortality in hospital(one month)
- Need for resuscitation(one hour)
- Apgar score at one minute(one minute after delivery)
- Apgar score at 5 minutes(5 minutes after delivery)
- The need for blood transfusion during hospital stay(one month)
- Venous Hgb(2 days)
- Venous hematocrit(2 days)
- Bilirubin level(24 hours after birth)
- Sepsis(one month)
- Polycythemia(first 48 hours after birth)
- Respiratory distress syndrome(48 hours after birth)
- Oxygen dependency(first 28 days after birth and 36 weeks corrected age)
- Need for volume administration(24 hours after birth)
- Use of inotropes(First 24 hours)
- Necrotizing enterocolitis(one month)
- Maximum bilirubin level(first week of life)
- Maternal mortality(2 weeks)
- Post partum hemorrhage(one day)
- Maternal need for blood transfusion(First 48 hours after delivery)
- Length of third stage(24 hours)
研究者
Heidi Al-Wassia
Assistant Professor
King Abdulaziz University