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

Gastroesophageal Reflux Disease Clinical Trial

— GERD-BPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00926276
• Other study ID #: GERD-BPD
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2009
• Last updated: December 9, 2014
• Start date: June 2009
• Est. completion date: May 2013

Study information

• Verified date: December 2014
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Weeks to 1 Year

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Procedure:
• Fundoplication
Fundoplication

Locations

Country	Name	City	State
United States	UT-Houston Pediatric Surgery & Memorial Hermann Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the efficacy of fundoplication in premature infants with GERD and BPD.		Three months	No
Secondary	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	No