Hemodynamic Changes With Umbilical Cord Milking in Nonvigorous Newborns
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Birth Asphyxia
- 发起方
- Sharp HealthCare
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Left Ventricular Output
- 状态
- 已完成
- 最后更新
- 去年
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
研究者
Anup Katheria, M.D.
Director, Neonatal Research Institute
Sharp HealthCare
入排标准
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.
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)