A Cluster Randomized Clinical Trial of Umbilical Cord Milking Compared to Early Cord Clamping in Preterm Infants Who Are Non-vigorous at Birth
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 18
- 主要终点
- In-hospital mortality
研究概览
简要总结
The goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks and 34 weeks of gestation.
详细描述
Background: Prematurity is the leading cause of death in children younger than 5 years of age. Worldwide, 15 million infants are born premature, and India alone contributes to quarter of them. Approximately 1 million children die each year due to complications of prematurity.
Delayed cord clamping (DCC), one of the methods of transfer of placental blood to neonates (placental transfusion) immediately after birth reduce mortality by 30% in premature infants. But DCC is not recommended in neonates who require immediate resuscitation. Umbilical cord milking (UCM) is an option for placental transfusion in preterm infants who require immediate resuscitation but not currently recommended due to lack of randomized clinical trials.
HYPOTHESIS
UCM will reduce the in-hospital mortality in non-vigorous preterm infants born between 30 weeks to 34 weeks of gestation compared to early cord clamping.
METHODS: This multicenter cluster crossover randomized trial will enroll approximately 800 preterm infants to early cord clamping or milking the intact cord 4 times prior to clamping.
IMPACT: If investigators find that UCM is beneficial, this simple, low-tech, no cost intervention can be used in preventing deaths in preterm infants. This trial will potentially provide evidence to support a change in guidelines making UCM part of standard practice worldwide for preterm infants who require immediate resuscitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 0 Minutes 至 10 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born between 30 0/7 weeks to 34 6/7 weeks of gestation
- •Non-vigorous at birth
排除标准
- •Infants with congenital malformation
- •Major chromosomal abnormalities
- •Complete placental abruption/cutting through the placenta at the time of delivery
- •Cord conditions (umbilical knots, inadequate cord length, cord rupture, non-reducible nuchal cord)
- •Mono-chorionic twins,
- •Twins with no information on amnion/chorion
- •Multiple gestation >2
研究组 & 干预措施
Umbilical Cord Milking
The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk 20-30 centimeters length of the umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for early cord clamping (ECC).
干预措施: Umbilical cord milking (Procedure)
Early Cord Clamping
Umbilical cord will be clamped immediately after birth (within 60 seconds)
结局指标
主要结局
In-hospital mortality
时间窗: From date of birth until the date of discharge from the hospital or date of death from any cause, whichever come first, assessed up to 12 weeks
Death of a baby during birth hospitalization
次要结局
- Hemoglobin at or after 24 hours(Days 1-7)
- Early and late onset culture positive sepsis(From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.)
- Any intraventricular hemorrhage (IVH) and severe IVH (grade 3 or 4)(From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.)
- Need for blood transfusion(From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.)
- Moderate to severe hypoxemic ischemic encephalopathy(From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.)
- Necrotizing enterocolitis (Bell's stage 2 or higher)(From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.)
- Need for medications for hypotension(From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.)
- Need for phototherapy for jaundice(From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.)
- Retinopathy of prematurity (ROP) requiring intervention(From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.)
- Length of hospitalization(From date of birth until the date of discharge from the hospital, assessed up to 12 weeks.)
研究者
Zubair Aghai
Professor of Pediatrics
Nemours Children's Clinic