Umbilical Cord Milking in Non-Vigorous Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,730
- 试验地点
- 20
- 主要终点
- Number of Neonatal Participants Admitted to the NICU for Predefined Criteria
研究概览
简要总结
The investigators will conduct a study of non-vigorous term infants to determine if umbilical cord milking (UCM) results in a lower rate of NICU admissions than early clamping and cutting of the umbilical cord at birth for infants who need resuscitation.
详细描述
At birth, it is critical that an infant begins breathing quickly. The infant has to switch from relying on the placenta for oxygen to using its lungs for the first time. The currently recommended practice for infants who need resuscitation is to immediately clamp the umbilical cord. Animal studies show that clamping the cord before the baby breathes can cause the heart beat to slow and can decrease the amount of blood being pumped out of the heart each minute. This study will test whether infants will benefit from UCM. The cord will be quickly milked four times before cutting and will not delay the resuscitation procedures. This study is important because when there is need for resuscitation, neither UCM or delayed cord clamping, are recommended by national and international organizations due to lack of evidence. Yet, several large studies from around the world have identified that infants needing resuscitation are more likely to develop conditions such as cerebral palsy, autism and other developmental problems.
The trial is a cluster crossover design in which each hospital will be randomly assigned to use either early cord clamping or UCM for any infant needing resuscitation over a period of 12 months. Then sites will change to the other method for an additional 12 months.
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
- 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
- 否
入选标准
- •Non-vigorous newborns born between 35-42 weeks gestation
排除标准
- •Known major congenital or chromosomal anomalies of newborn
- •Known cardiac defects other than small ASD, VSD and PDA
- •Complete placental abruption/cutting through the placenta at time of delivery
- •Monochorionic multiples
- •Cord anomaly (i.e. cord avulsion, true knot)
- •Presence of non-reducible nuchal cord
- •Perinatal providers unaware of the protocol
- •Incomplete delivery data
- •Infants born in extremis, for whom additional treatment will not be offered
结局指标
主要结局
Number of Neonatal Participants Admitted to the NICU for Predefined Criteria
时间窗: Birth to first 48 hours of life.
Number of neonatal participants admitted to the neonatal intensive care unit for study-specific predefined criteria including respiratory distress, oxygen desaturation, hypoglycemia, hypotonia, apnea, lethargy or difficulty arousing, hypertonia or irritability, temperature instability, bradycardia or tachycardia, seizures or seizure-like activity, poor feeding or emesis, hyperbilirubinemia, death before NICU admission.
次要结局
- Median Neonatal Hemoglobin Between 12 to 48 Hours of Life(12-48 hours of life)
- Number of Neonates Treated With Therapeutic Hypothermia ("Cooling")(Birth to 78 hours of life.)
- Number of Neonates Treated With Normal Saline Bolus in the First 24 Hours of Life(Birth through 24 hours of life)
- Median Peak Total Serum Bilirubin in Neonates(First week of life)
- Median Transcutaneous Bilirubin in Neonates(birth to 7 days of life)
- Number of Neonatal Deaths(Birth to discharge, assessed up to 180 days of life.)
研究者
Anup Katheria, M.D.
Director, Neonatal Research Institute
Sharp HealthCare