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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01029665
First received: November 19, 2009
Last updated: March 7, 2013
Last verified: March 2013

November 19, 2009
March 7, 2013
September 2008
November 2009   (final data collection date for primary outcome measure)
Persistent medical morbidities and/or neurodevelopmental impairment at school age (ages 4-6). [ Time Frame: Visit 1 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01029665 on ClinicalTrials.gov Archive Site
Not Provided
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Early Childhood Follow-up of Congenital Diaphragmatic Hernia Survivors
Early Childhood Follow-up of Congenital Diaphragmatic Hernia Survivors

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Not Provided
Non-Probability Sample

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.

Hernia, Diaphragmatic
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CDH survivors
School age (ages 4-6) Congenital Diaphragmatic Hernia survivors treated at Duke University Medical Center.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2010
November 2009   (final data collection date for primary outcome measure)

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.
Both
4 Years to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01029665
Pro00006486, 392-1577
No
Duke University
Duke University
Not Provided
Principal Investigator: Jennifer R Benjamin, MD Duke University
Duke University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP