Delayed Cord Clamping for Congenital Diaphragmatic Hernia (DING)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Congenital Diaphragmatic Hernia

Treatments: Procedure: DING

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03314233

K23HD084727 (U.S. NIH Grant/Contract)

17-014125

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 21 patients

Sex: All

Ages: 1 to 1 day old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

DING intervention

Experimental group

Description:

Delayed Cord Clamping

Treatment:

Procedure: DING