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Trial record 3 of 29 for:    Recruiting, Not yet recruiting, Available Studies | "Hernia, Diaphragmatic"

Delayed Cord Clamping for Congenital Diaphragmatic Hernia (DING)

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ClinicalTrials.gov Identifier: NCT03314233
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief 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.


Condition or disease Intervention/treatment Phase
Congenital Diaphragmatic Hernia Procedure: DING Not Applicable

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 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  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Official Title: Delayed Cord Clamping for Intubation and Gentle Ventilation in Infants With Congenital Diaphragmatic Hernia
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019


Arm Intervention/treatment
Experimental: DING intervention
Delayed Cord Clamping
Procedure: DING
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 Outcome Measures :
  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 Outcome Measures :
  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 24 hours of life ]
    Oxygenation index [OI] in first 24 hours of life

  4. Proportion of infants who require vasopressors [ Time Frame: First 24 hours of life ]
    Proportion of infants who require vasopressors in first 24 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



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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314233


Contacts
Contact: Elizabeth Foglia, MD 215-590-1653 foglia@email.chop.edu
Contact: Aasma Chaudhary 215-662-3228 chaudharya@email.chop.edu

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Elizabeth Foglia, MD    215-590-1653    foglia@email.chop.edu   
Contact: Aasma Chaudhary    215-662-3228    chaudharya@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Institutes of Health (NIH)
Investigators
Principal Investigator: Elizabeth Foglia, MD Childrens Hospital of Philadelphia

Publications:
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03314233     History of Changes
Other Study ID Numbers: 17-014125
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hernia
Hernia, Diaphragmatic
Hernias, Diaphragmatic, Congenital
Pathological Conditions, Anatomical
Congenital Abnormalities