Umbilical Cord Milking Versus Immediate Cord Clamping in Full Term Neonates (≥ 37 Weeks) Requiring Resuscitation - A RANDOMIZED CONTROL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Incidence of Hypoxic Ischemic Encephalopathy
研究概览
简要总结
The objective of the study is to compare the incidence of Hypoxic ischemic encephalopathy (all stages) among singleton term neonates (≥ 37 weeks) requiring resuscitation who will undergo Umbilical cord milking as compared to Immediate cord clamping.
详细描述
Enrolled participants will be randomly allocated to one of two study groups: 1) Umbilical cord clamping, 2) Immediate cord clamping
Umbilical cord clamping group: In the babies requiring resuscitation during vaginal delivery, the delivering obstetrician will place the infant on the mother's abdomen and about 20 cm of umbilical cord would be milked towards the infant with intact umbilical cord. The cord milking will be done four times by the obstetrical provider or by a second team member at the rate of 20 cm/2 sec. This procedure can be done in 15-20 seconds. Length of 20 cm can be estimated by the length of a sponge holding forceps which is approximately 25 cm. The umbilical cord will then clamped 2 -3 cm from the umbilical stump.
Immediate cord clamping: This will occur by clamping the umbilical cord as soon as possible (average 30 seconds).
Further resuscitation will be done in accordance with NRP 2015 guidelines. Stop watch will be used to calculate the duration after which the cord is clamped and cut, time to first breath, and time required to achieve HR > 100/min
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 37 Weeks 至 41 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vaginally born, Singleton Term gestation (≥ 37 and & < 42 weeks), requiring resuscitation at birth
排除标准
- •Major congenital anomaly (antenatally diagnosed or visible at birth)
- •Rh negative pregnancy
- •Abruptio Placneta/ Placenta previa
- •Fetus with absent and reversal of End Diastolic flow
- •Cord avulsion
- •Refusal of consent
结局指标
主要结局
Incidence of Hypoxic Ischemic Encephalopathy
时间窗: From date of birth until date of death from any cause whichever come first assessed till 1 week of life
any stage as per Sarnat and Sarnat Staging
次要结局
- Proportion requiring NICU admission(Till 1 week of life)
- Neonates requiring Initial steps of resuscitation, Bag and Mask Ventilation, Intubation, chest compression and administration of drugs during resuscitation.(Till 1 minutes of life)
- Proportion of neonates developing polycythemia(Till first 72 hours)
- Proportion of mortality due to any cause(From date of birth until date of death from any cause whichever come first assessed till 4 week of life)
- Hyperbilirubinemia requiring phototherapy(From date of birth until date of death from any cause whichever come first assessed till 4 week of life)
- Level of hypoxic ischemic encephalopathy ( mild, moderate or severe)(From date of birth until date of death from any cause whichever come first assessed till 1 week of life)
- Mean Blood Pressure at 2,6,12,24,48,72 hrs(From date of birth until date of death from any cause whichever come first assessed till 72 hours of life)
- Received blood products or saline bolus or inotropes to support blood pressure(From date of birth until date of death from any cause whichever come first assessed till 1 week of life)
- Length of hospital stay(From date of birth until date of death from any cause whichever come first assessed till 4 week of life)
- Proportion of neonates having APGAR score < 4 at 5 minutes of life(Till 5 minutes of life)
研究者
Sushma Nangia, M.D.
Dr. Sushma Nangia, Director Professor & Head, Department of Neonatology
Lady Hardinge Medical College