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

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

Detailed Description
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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.

Official Title
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The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia (BPD).

Conditions
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Gastroesophageal Reflux Disease, Bronchopulmonary Dysplasia

Intervention / Treatment
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* Procedure: Fundoplication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgical Treatment Group-Fundoplication<br>Re-evaluated 1 month post-op Re-evaluated 2 months post-op | Procedure: Fundoplication<br>* Fundoplication<br>|
| Active Comparator: Medical Therapy<br>Treated by primary clinician for GERD Re-evaluated 1 month Proceed to Fundoplication if GERD persist by pH-MII Re-evaluated at 2 months (1 month post-op) Worsening BPD will be given option of immediate surgery | Procedure: Fundoplication<br>* Fundoplication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of fundoplication in premature infants with GERD and BPD. |  | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal Reflux Disease (GERD), Bronchopulmonary Dysplasia (BPD), Fundoplication