Delayed Cord Clamping for Congenital Diaphragmatic Hernia
Condition: Congenital Diaphragmatic Hernia
MeSH terms: Hernias, Diaphragmatic, Congenital; Hernia; Hernia, Diaphragmatic
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): DING
Intervention type(s): Procedure
Intervention description(s): Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.
Intervention model: Single Group Assignment
Intervention model description: Unblinded single-arm pilot interventional trial. All enrolled infants will receive the DING intervention (Delayed cord clamping for INtubation and Gentle ventilation)
Masking: None (Open Label)
Primary purpose: Other