Hemodynamic Changes With Umbilical Cord Milking in Nonvigorous Newborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Left Ventricular Output
研究概览
简要总结
Non-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing data collection. As part of the data collection, an optional echocardiogram will be performed if the parent consents.
详细描述
Non-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing data collection. As part of the data collection, an optional echocardiogram will be performed if the parent consents. The consent will have a check box to indicate if they consent to the additional test.
Echocardiographic measurements will be performed on all infants at 12 hours +/- 6 hours of age by our research sonographers who are blinded to infant randomization. Measurements will be taken according to a standard operating procedure to assess systemic blood flow, by superior vena cava (SVC) flow (ml/kg/min), right ventricular output (ml/kg/min), left ventricular output (LVO) (ml/kg/min), measures of left and right ventricular tissue Doppler and strain imaging. These measurements will be performed offline at a later time. Data will be entered into REDCap.
If any structural abnormalities are found, the attending pediatrician will be notified of the abnormal echocardiogram. The consent will clearly state that this echo is not for diagnostic purposes. Any additional studies including an official complete echocardiogram and or cardiology consultation will be left to the discretion of the attending pediatrician, as he/she deems necessary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Cardiac research sonographers that obtained study measurements were blinded to the study intervention
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 atrial septal defect (ASD), ventricular septal defect (VSD) and patent ductus arteriosus (PDA).
- •Complete placental abruption/cutting through the placenta at time of delivery.
- •Monochorionic multiples
- •Cord anomaly (i.e. cord avulsion or 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.
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 the entire length of 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 as we have demonstrated in our previous trials.
干预措施: Umbilical Cord Milking (Procedure)
Early Cord Clamping
This will occur by clamping the umbilical cord as soon as possible. Since both Early Cord Clamping and Umbilical Cord Milking will occur after a brief assessment, it is important to note that the cord clamping time will be longer than in previously conducted preterm trials (average 20 seconds) which performed the intervention on all subjects regardless of whether or not they were vigorous. In all cases, the cord clamping time will be documented to ensure consistency.
干预措施: Early Cord Clamping (Procedure)
结局指标
主要结局
Left Ventricular Output
时间窗: 12 ± 6 hours of life
Left ventricular output measurements taken by cardiac ultrasound.
次要结局
- Neonatal Right Ventricular Output(12 ± 6 hours of life)
- Neonatal Superior Vena Cava Flow(12 ± 6 hours of life)
- Neonatal Peak Systolic Strain(12 ± 6 hours of life)
- Neonatal Peak Systolic Velocity(12 ± 6 hours of life)
研究者
Anup Katheria, M.D.
Director, Neonatal Research Institute
Sharp HealthCare