The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia

Completed · Phase 4

Conditions studied: Gastroesophageal Reflux Disease, Bronchopulmonary Dysplasia

In brief

The purpose of this study is to evaluate the efficacy of fundoplication in premature infants with GERD and BPD.

Key facts

Study ID

NCT00926276

Run by

The University of Texas Health Science Center, Houston

People needed

2

Starts

2009-06-01

Expected to finish

2013-05-01

Last updated by the study team

2014-12-11

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• UT-Houston Pediatric Surgery & Memorial Hermann Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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