Extrauterine Placental Transfusion In Neonatal Resuscitation (EXPLAIN) of Very Low Birth Weight Infants (VLBW): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hematocrit
研究概览
简要总结
To investigate the effect of extrauterine placental transfusion (EPT) compared to delayed cord clamping (DCC) on the mean hematokrit on the first day of life in very low birth weight infants (VLBW) born by caesarian section. The investigators hypothesize that EPT provides higher blood volume during neonatal transition and improves neonatal outcome of VLBW infants.
详细描述
This prospective randomized controlled study will be conducted among 2 groups, all of them are preterm infants with birth weight less than 1500 g ("very low birth weight" (VLBW)) who are delivered by caesarean section, in the first interventional group an extrauterine placental transfusion (EPT) will be done during neonatal resuscitation with respiratory pressure support. There will be a delayed cord clamping (DCC) of at least 30 - 60 seconds in the control group, before starting neonatal resuscitation with respiratory support.
In EPT approach preterm born infants are delivered by caesarean section with the placenta still attached to the infant via the umbilical cord. Then, placental transfusion is performed up to several minutes by holding the placenta ~40-50cm above the babies' heart level while respiratory support by mask continuous-positive-airway-pressure (CPAP) is initiated simultaneously.
Extrauterine placental transfusion may give more blood in babies delivered by cesarean section and may improve perfusion during the fetal-to-neonatal transition with impact on neonatal outcome.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 24 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight < 1500 gram ("very low birth weight infant")
- •Delivery by caesarean section
- •Gestational age > 23+6 weeks
排除标准
- •Vaginal delivery
- •Fetal or maternal risk (i.e. compromise, emergency c-section)
- •Congenital anomalies and/or major cardiac defects
- •Placental abruption or previa with hemorrhage
- •Placenta accreta or increta
- •Monochorionic multiples (i.e. Di/Mo or Mo/Mo twins)
- •Parents declined study
结局指标
主要结局
Hematocrit
时间窗: 0 - 24 hours of life
Mean Hematocrit in the first 24 hours of life
次要结局
- Mean airway pressure(During first hour of life)
- Heart rate(During first hour of life)
- Admission temperature(Admission to ward is up to 120 minutes of age)
- All Grade Intraventricular Hemorrhage (IVH)(Up to 28 days of life)
- Cerebral tissue oxygen saturation(During first hour of life)
- Mean tidal volume(During first hour of life)
- Blood oxygen saturation(During first hour of life)
- All Grade BPD(At the corrected age of 36 weeks)
- Spontaneous Pneumothorax/Pneumoperitoneum(Between day 7 and day 28 of life)
- NEC/SIP with surgery(During the first 28 days of life)
- Retinopathy of Prematurity (ROP), higher grades(At the corrected age of 40 weeks)
- Death(Until corrected age of 40 weeks)
- Number of participants who received red blood cell (RBC) transfusion(During the first 7 days of life)
- Hyperbilirubinemia(During the first 14 days of life)
- Blood Exchange Transfusion(During the first 14 days of life)
- Intubation and Mechanical Ventilation(During hospitalization)
- Neurodevelopmental Outcome(22-26 month corrected gestational age)
研究者
Andre Oberthür
Principal Investigator
Universitätsklinikum Köln