Delayed Cord Clamping for Congenital Diaphragmatic Hernia

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.

Inclusion Criteria:

1. Antenatal diagnosis of CDH, with care in the Center for Fetal Treatment

2. Gestational age ≥ 36 weeks at birth

Exclusion Criteria:

1. Multiple gestation

2. Major anomalies or aneuploidy

3. Enrolled in fetal endoluminal tracheal occlusion (FETO) trial

4. Palliative care planned or considered

5. Maternal diagnosis placenta previa, accreta, or abruption

6. Maternal diagnosis pre-eclampsia requiring Magnesium sulfate therapy at time of
delivery

7. Obstetrics (OB) or Neonatal provider concerns for the clinical care of the mother or
infant, or study team not available