Milking of the Cut-Cord During Resuscitation of Preterm Infants: A Randomized Controlled Trial (The MOCC Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Number of adverse events associated with the MOCC intervention
研究概览
简要总结
In this feasibility study, the investigators will randomize preterm infants born at <32 weeks gestation to either the standard practice of delayed cord clamping (DCC) for 30-60 seconds at birth or milking of the long-cut cord (MOCC) while providing resuscitation/stabilization to the infant. The main objectives of the trial are to assess the feasibility of the new approach (MOCC) and to compare the two groups regarding the hemoglobin levels on admission to NICU in addition to neonatal morbidity and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Minute（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants <32 weeks' gestation
排除标准
- •Clinical evidence of interrupted placental circulation (placental abruption or avulsed cord) or bleeding from placenta previa.
- •Monochorionic twins or any higher order multiple pregnancy
- •Major fetal congenital or chromosomal abnormality
- •Documented fetal anemia or in utero red blood cell transfusion
- •Intent to withhold or withdraw treatment of the infant
研究组 & 干预措施
MOCC Group
The OB provider will hold the baby at/below the placenta, provide warmth, stimulate the baby and suction the mouth/nose for 30 secs.S/He will then clamp and cut the cord about 5 cm from the the introitus (vaginal deliveries) or from the abdominal incision (C-Sections) before handing the baby with the long-cut cord to the neonatal team to resuscitate/ stabilize the baby. A member of the neonatal team will milk the long-cut cord slowly 1 time from the cut end toward the infant over 10 secs before clamping and cutting the cord 1-2 cm from the umbilical stump. The neonatal team will provide PPV to the baby (during the milking process) if the baby is not breathing. If the baby is breathing during the milking process the team will continue the stabilization as per standard NRP practice.
干预措施: MOCC Group (Procedure)
DCC group
The OB provider will hold the baby at or below the level of placenta, provide warmth, stimulate the baby to breathe and suction the mouth/nose if needed for the first 30 seconds.
After these initial 30 seconds, if the baby is breathing then the obstetrician will continue DCC for a total of 60 seconds before clamping and cutting the cord close to the umbilicus and handing over the baby to the neonatal team for further stabilization as per standard NRP practice. If the baby is not breathing after the initial 30 seconds of DCC, then the OB provider will clamp and cut the cord close to the umbilicus and hand over the baby to the neonatal team to continue resuscitation of the baby as per the standard NRP guidelines.
干预措施: DCC Group (Procedure)
结局指标
主要结局
Number of adverse events associated with the MOCC intervention
时间窗: Till the participants reach 2 year- corrected age (around 4.5 years)
To investigate any adverse events that could be attributed to the MOCC intervention.
Rate of compliance to the study intervention
时间窗: Two years
to investigate the adherence to the new approach of MOCC during resuscitation/ stabilization following 30 seconds of DCC in preterm infants.
Number of patients completing the study
时间窗: Two years
To evaluate the number of patients who are recruited and completed the study to estimate the sample size needed for the design of a large multi-centre RCT.
次要结局
- Compare hemoglobin (Hgb) concentration(From date of randomization and assessed up to 24 hours of age)
研究者
Walid El-Naggar
Principle Investigator, Associate Professor of Pediatrics
IWK Health Centre