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Completed

NCT Number: NCT03314233

Delayed Cord Clamping for Congenital Diaphragmatic Hernia

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.

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Key information

Conditions

Congenital Diaphragmatic Hernia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Diaphragmatic Hernias, Diaphragmatic, Congenital Internal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

1 day–1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DING

Procedure

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.

Primary outcomes

  1. Proportion of Infants Who Are Intubated Prior to Umbilical Cord Clamping

    Time frame: 3 minutes of life

    Infants who are intubated and have ventilation initiated prior to umbilical cord clamping

Secondary outcomes

  1. Mean Arterial Potential of Hydrogen (pH) in Arterial Blood

    Time frame: Approximately 1 hour of life

    Arterial pH on first blood gas

  2. Mean Partial Pressure of O2 in Arterial Blood (PaO2)

    Time frame: Approximately 1 hour of life

    Arterial PaO2 on first blood gas

  3. Oxygenation Index (OI)

    Time frame: First obtained blood gas

    Oxygenation index [OI] with first obtained blood gas

  4. Proportion of Infants Who Require Vasopressors

    Time frame: First 48 hours of life

    Proportion of infants who require vasopressors in first 48 hours of life

  5. Presence of Severe Pulmonary Hypertension

    Time frame: Approximately 24 hours of life

    Presence of severe pulmonary hypertension on first echocardiogram

  6. Proportion of Infants Who Require Extracorporeal Membrane Oxygenation (ECMO) Treatment

    Time frame: 7 days of life

    Proportion of infants who require ECMO treatment in first 7 days of life

  7. Mortality in First 7 Days of Life

    Time frame: First 7 days of life

    Proportion of infants with mortality in the first 7 days of life

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Delayed Cord Clamping for Intubation and Gentle Ventilation in Infants With Congenital Diaphragmatic Hernia

Acronym: DING

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 19, 2017
Registry last updated
Jan 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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