Bronchopulmonary Dysplasia, Gastroesophageal Reflux Disease
Conditions
Keywords
Gastroesophageal Reflux Disease (GERD), Bronchopulmonary Dysplasia (BPD), Fundoplication
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) in premature infants. This association has been indirectly based on anecdotal improvement in the respiratory status of infants with BPD after anti-reflux therapy, but the direct causal relationship has been difficult to prove. In addition, the historical evidence for infants with GERD has been based on acid reflux only which is diagnosed by 24 hour intra-esophageal pH monitoring, the gold standard. However, with the introduction of multi-channel intraluminal impedance (MII), GERD can now include non-acid reflux. The contribution of non-acid reflux to the development of BPD in premature infants is unknown. As our understanding of GERD has improved, previous assumptions regarding the efficacy of therapy may no longer be valid. The utilization of anti-reflux surgery (fundoplication) for the treatment of BPD in premature infants with GERD has not been rigorously studied. The efficacy of fundoplication in this patient population has yet to be determined.
Interventions
PROCEDUREFundoplication
Fundoplication
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 1 Years
Healthy volunteers
No
Inclusion criteria
1. Must meet all inclusion criteria for Initial Evaluation of GERD 2. Positive pH-MII test for GERD 3. Upper GI contrast radiograph to evaluate for associated congenital gastrointestinal anomalies 4. \> or = 2 kg (due to technical limitations of fundoplication)
Exclusion criteria
1. Previous intra-abdominal surgery except for gastrostomy 2. Those deemed not surgical candidates 3. Infants with associated congenital gastrointestinal anomalies 4. \> or = 1 year of age at time of Initial Evaluation of GERD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of fundoplication in premature infants with GERD and BPD. | Three months |
Secondary
| Measure | Time frame |
|---|---|
| Establish preliminary data regarding the correlation between acid and non-acid GERD and pepsin from tracheal aspirates as a marker of chronic aspiration in premature infants with BPD. | Six months |
Countries
United States
Outcome results
None listed