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

March 7, 2013 updated by: Duke University
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.

Study Overview

Status

Completed

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

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Jennifer R Benjamin, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 19, 2009

First Submitted That Met QC Criteria

December 9, 2009

First Posted (Estimate)

December 10, 2009

Study Record Updates

Last Update Posted (Estimate)

March 11, 2013

Last Update Submitted That Met QC Criteria

March 7, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hernia, Diaphragmatic

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