Status:
COMPLETED
The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Gastroesophageal Reflux Disease
Bronchopulmonary Dysplasia
Eligibility:
All Genders
24-1 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy of fundoplication in premature infants with GERD and BPD.
Detailed Description
Gastroesophageal reflux disease (GERD) has been postulated to result in chronic aspiration contributing to the development of chronic lung disease, otherwise known as bronchopulmonary dysplasia (BPD) ...
Eligibility Criteria
Inclusion
- Must meet all inclusion criteria for Initial Evaluation of GERD
- Positive pH-MII test for GERD
- Upper GI contrast radiograph to evaluate for associated congenital gastrointestinal anomalies
- \> or = 2 kg (due to technical limitations of fundoplication)
Exclusion
- Previous intra-abdominal surgery except for gastrostomy
- Those deemed not surgical candidates
- Infants with associated congenital gastrointestinal anomalies
- \> or = 1 year of age at time of Initial Evaluation of GERD
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00926276
Start Date
June 1 2009
End Date
May 1 2013
Last Update
December 11 2014
Active Locations (1)
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1
UT-Houston Pediatric Surgery & Memorial Hermann Children's Hospital
Houston, Texas, United States, 77030