Delayed Cord Clamping for Congenital Diaphragmatic Hernia
Completed · Not applicable
Conditions studied: Congenital Diaphragmatic Hernia
In brief
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.
Key facts
- Study ID
- NCT03314233
- Run by
- Children's Hospital of Philadelphia
- People needed
- 21
- Starts
- 2017-10-12
- Expected to finish
- 2018-10-09
- Last updated by the study team
- 2020-01-21
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Antenatal diagnosis of CDH, with care in the Center for Fetal Treatment
- Gestational age ≥ 36 weeks at birth
You may not qualify if…
- 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
Where it is running
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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