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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
21
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.
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Proportion of Infants Who Are Intubated Prior to Umbilical Cord Clamping
Infants who are intubated and have ventilation initiated prior to umbilical cord clamping
Time frame: 3 minutes of life
Mean Arterial Potential of Hydrogen (pH) in Arterial Blood
Arterial pH on first blood gas
Time frame: Approximately 1 hour of life
Mean Partial Pressure of O2 in Arterial Blood (PaO2)
Arterial PaO2 on first blood gas
Time frame: Approximately 1 hour of life
Oxygenation Index (OI)
Oxygenation index \[OI\] with first obtained blood gas
Time frame: First obtained blood gas
Proportion of Infants Who Require Vasopressors
Proportion of infants who require vasopressors in first 48 hours of life
Time frame: First 48 hours of life
Presence of Severe Pulmonary Hypertension
Presence of severe pulmonary hypertension on first echocardiogram
Time frame: Approximately 24 hours of life
Proportion of Infants Who Require Extracorporeal Membrane Oxygenation (ECMO) Treatment
Proportion of infants who require ECMO treatment in first 7 days of life
Time frame: 7 days of life
Mortality in First 7 Days of Life
Proportion of infants with mortality in the first 7 days of life
Time frame: First 7 days of life
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.