Early Childhood Follow-up of Congenital Diaphragmatic Hernia Survivors

Hernia, Diaphragmatic Clinical Trial

— CDH  

Official title:

Early Childhood Follow-up of Congenital Diaphragmatic Hernia Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029665
• Other study ID #: Pro00006486
• Secondary ID: 392-1577
• Status: Completed
• Start date: September 2008
• Est. completion date: December 2010

Study information

• Verified date: March 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persistent medical morbidities and/or neurodevelopmental impairment at school age (ages 4-6).		Visit 1