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.|
|ClinicalTrials.gov Identifier: NCT01029665|
Recruitment Status : Completed
First Posted : December 10, 2009
Last Update Posted : March 11, 2013
|Condition or disease|
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|
|Official Title:||Early Childhood Follow-up of Congenital Diaphragmatic Hernia Survivors|
|Study Start Date :||September 2008|
|Primary Completion Date :||November 2009|
|Study Completion Date :||December 2010|
School age (ages 4-6) Congenital Diaphragmatic Hernia survivors treated at Duke University Medical Center.
- Persistent medical morbidities and/or neurodevelopmental impairment at school age (ages 4-6). [ Time Frame: Visit 1 ]
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): NCT01029665
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Jennifer R Benjamin, MD||Duke University|