Early Childhood Follow-up of Congenital Diaphragmatic Hernia Survivors (CDH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01029665
Recruitment Status : Completed
First Posted : December 10, 2009
Last Update Posted : March 11, 2013
Information provided by (Responsible Party):
Duke University

Brief Summary:
The primary objective of this study is to determine the medical and neurodevelopmental outcomes of congenital diaphragmatic hernia (CDH) survivors at school-age (4-6 years) follow-up. It is generally assumed that older CDH survivors have normal daily function and are able to live normal lives, but this has not been adequately studied.

Condition or disease
Hernia, Diaphragmatic

Detailed Description:

Congenital diaphragmatic hernia (CDH) is a relatively rare malformation, seen in approximately 1 in 3000-5000 live births. The overall survival for infants born with CDH ranges from 50-70% despite continuing advances in prenatal diagnosis and post-natal medical and surgical care. Infants with CDH remain one of the most complex groups of patients to care for - both in the intensive care nursery and after hospital discharge.

Several studies have shown that CDH survivors have predictable pulmonary, gastrointestinal, cardiac, and neurologic morbidities. In particular, CDH survivors are at an increased risk for growth and nutrition difficulties, including feeding problems, symptomatic gastroesophageal reflux, and failure to thrive. They are also more likely to suffer from chronic lung disease, bronchial hyperreactivity, and pulmonary hypertension. In addition, a significant number of CDH survivors show evidence of neurocognitive delay, hearing impairment, and behavioral disorders in follow-up studies.

Most outcome studies of CDH survivors have focused on the 18-36 month follow-up period. However, there is a paucity of literature on longer-term, school-age outcomes of these children. In order that we might better understand the impact of our current CDH management protocols, it is imperative to determine whether the cognitive delays and other morbidities noted in these patients at an early age are of a transient nature, or persist throughout childhood. It is also crucial to develop a predictive model to understand which patients with CDH will undoubtedly develop long-term neurodevelopmental impairment. Collecting and sharing knowledge with the broader community of Neonatal Intensive Care providers who manage infants with CDH will ultimately help guide therapeutic strategies in the intensive care nursery so that parents can make informed decisions about aggressiveness of care and we may optimize the outcomes of this unique patient population.

Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Childhood Follow-up of Congenital Diaphragmatic Hernia Survivors
Study Start Date : September 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2010

CDH survivors
School age (ages 4-6) Congenital Diaphragmatic Hernia survivors treated at Duke University Medical Center.

Primary Outcome Measures :
  1. Persistent medical morbidities and/or neurodevelopmental impairment at school age (ages 4-6). [ Time Frame: Visit 1 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All infants with Congenital Diaphragmatic Hernia (CDH) born between 2001 and 2005 who were managed at Duke University Medical Center will be eligible for inclusion in the study.

Inclusion Criteria:

  • Survivors of CDH who are at least 4 years old at the time of the study will be eligible for inclusion in the follow-up portion of the study.

Exclusion Criteria:

  • Spanish-speaking only children and families.

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 identifier (NCT number): NCT01029665

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Principal Investigator: Jennifer R Benjamin, MD Duke University

Responsible Party: Duke University Identifier: NCT01029665     History of Changes
Other Study ID Numbers: Pro00006486
392-1577 ( Other Grant/Funding Number: Discovery Labs )
First Posted: December 10, 2009    Key Record Dates
Last Update Posted: March 11, 2013
Last Verified: March 2013

Keywords provided by Duke University:
Hernia, Diaphragmatic
Feeding and Eating Disorders of Childhood
Growth & Development

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