Delayed Cord Clamping for Intubation and Gentle Ventilation in Infants With Congenital Diaphragmatic Hernia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Proportion of Infants Who Are Intubated Prior to Umbilical Cord Clamping
研究概览
简要总结
Congenital diaphragmatic hernia (CDH) is a congenital anomaly associated with a high risk of mortality and need for life-saving interventions such as extracorporeal membrane oxygenation (ECMO), nitric oxide, and vasopressor support. Although infants with CDH experience significant morbidity and mortality starting immediately after birth, high quality evidence informing delivery room resuscitation in this population is lacking.
Infants with CDH are at risk for pulmonary hypoplasia and pulmonary hypertension and often experience hypoxemia and acidosis during neonatal transition. The standard approach to DR resuscitation is immediate umbilical cord clamping (UCC) followed by intubation and mechanical ventilation. Animal models suggest that achieving lung aeration prior to UCC results in improved pulmonary blood flow and cardiac function compared with immediate UCC before lung aeration is established. Trials of preterm infants demonstrated that initiating respiratory support prior to UCC is safe and feasible. Because infants with CDH are at high risk for pulmonary hypertension and systemic hypotension, they may benefit from the hemodynamic effects of lung aeration before UCC, namely increased pulmonary blood flow, decreased pulmonary vascular resistance, and improved cardiac output. To date, this approach has not been studied in infants with CDH.
详细描述
Congenital diaphragmatic hernia (CDH) is a congenital anomaly associated with a high risk of mortality (29%) and need for life-saving interventions such as ECMO (33%), nitric oxide (62%), and vasopressor support (73%).1 Although infants with CDH experience significant morbidity and mortality starting immediately after birth, high quality evidence informing delivery room resuscitation in this population is lacking.
Infants with CDH are at risk for pulmonary hypoplasia and pulmonary hypertension and often experience hypoxemia and acidosis during neonatal transition. The standard approach to delivery room (DR) resuscitation is immediate UCC followed by intubation and mechanical ventilation. The goals of this strategy are to immediately recruit and aerate the lung for gas exchange and oxygenation, while simultaneously avoiding gaseous distention of the thoracic gastrointestinal contents.
Animal models suggest that achieving lung aeration prior to UCC results in improved pulmonary blood flow and cardiac function compared with immediate UCC before lung aeration is established. Trials of preterm infants demonstrated that initiating respiratory support prior to UCC is safe and feasible. Because infants with CDH are at high risk for pulmonary hypertension and systemic hypotension, they may benefit from the hemodynamic effects of lung aeration before UCC, namely increased pulmonary blood flow, decreased pulmonary vascular resistance, and improved cardiac output.
The investigators hypothesize that a sequence of intubation, gentle ventilation, and then umbilical cord clamping will result in improved cardiovascular transition after birth in infants with CDH. To date, this approach has not been studied in infants with CDH. The DING trial will assess the feasibility and safety of this intervention in infants with CDH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Antenatal diagnosis of CDH, with care in the Center for Fetal Treatment
- •Gestational age ≥ 36 weeks at birth
排除标准
- •Multiple gestation
- •Major anomalies or aneuploidy
- •Enrolled in fetal endoluminal tracheal occlusion (FETO) trial
- •Palliative care planned or considered
- •Maternal diagnosis placenta previa, accreta, or abruption
- •Maternal diagnosis pre-eclampsia requiring Magnesium sulfate therapy at time of delivery
- •Obstetrics (OB) or Neonatal provider concerns for the clinical care of the mother or infant, or study team not available
结局指标
主要结局
Proportion of Infants Who Are Intubated Prior to Umbilical Cord Clamping
时间窗: 3 minutes of life
Infants who are intubated and have ventilation initiated prior to umbilical cord clamping
次要结局
- Presence of Severe Pulmonary Hypertension(Approximately 24 hours of life)
- Proportion of Infants Who Require Extracorporeal Membrane Oxygenation (ECMO) Treatment(7 days of life)
- Mean Partial Pressure of O2 in Arterial Blood (PaO2)(Approximately 1 hour of life)
- Mean Arterial Potential of Hydrogen (pH) in Arterial Blood(Approximately 1 hour of life)
- Oxygenation Index (OI)(First obtained blood gas)
- Proportion of Infants Who Require Vasopressors(First 48 hours of life)
- Mortality in First 7 Days of Life(First 7 days of life)