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

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Gastroesophageal Reflux Disease; Bronchopulmonary Dysplasia

Treatments: Procedure: Fundoplication

Study type: Interventional

Funder types: Other

Identifiers

NCT00926276

GERD-BPD

Details and patient eligibility

About

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

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 24 weeks to 1 year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Surgical Treatment Group-Fundoplication

Active Comparator group

Description:

Re-evaluated 1 month post-op Re-evaluated 2 months post-op

Treatment:

Procedure: Fundoplication

Medical Therapy

Active Comparator group

Description:

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

Treatment:

Procedure: Fundoplication