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N/A N=21 Other

Delayed Cord Clamping for Congenital Diaphragmatic Hernia

Congenital Diaphragmatic Hernia

Enrolled (actual)
21
Serious AEs
15.0%
Results posted
Dec 2019
Primary outcome: Primary: Proportion of Infants Who Are Intubated Prior to Umbilical Cord Clamping — 17 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
DING (Procedure)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
Children's Hospital of Philadelphia
Primary completion
Oct 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Proportion of Infants Who Are Intubated Prior to Umbilical Cord Clamping
17
SECONDARY
Mean Arterial Potential of Hydrogen (pH) in Arterial Blood
7.02
SECONDARY
Mean Partial Pressure of O2 in Arterial Blood (PaO2)
47
SECONDARY
Oxygenation Index (OI)
17.5
SECONDARY
Proportion of Infants Who Require Vasopressors
13
SECONDARY
Presence of Severe Pulmonary Hypertension
12
SECONDARY
Proportion of Infants Who Require Extracorporeal Membrane Oxygenation (ECMO) Treatment
7
SECONDARY
Mortality in First 7 Days of Life

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • Antenatal diagnosis of CDH, with care in the Center for Fetal Treatment
  • Gestational age ≥ 36 weeks at birth

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03314233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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