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

NCT ID: NCT00926276

Last Updated: 2014-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-05-31

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.

Conditions

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Gastroesophageal Reflux Disease Bronchopulmonary Dysplasia

Keywords

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Gastroesophageal Reflux Disease (GERD) Bronchopulmonary Dysplasia (BPD) Fundoplication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical Treatment Group-Fundoplication

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

Group Type ACTIVE_COMPARATOR

Fundoplication

Intervention Type PROCEDURE

Fundoplication

Medical Therapy

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

Group Type ACTIVE_COMPARATOR

Fundoplication

Intervention Type PROCEDURE

Fundoplication

Interventions

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Fundoplication

Fundoplication

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

24 Weeks

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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KuoJen Tsao

Assistant Professor - Pediatric Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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KuoJen Tsao, M.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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UT-Houston Pediatric Surgery & Memorial Hermann Children's Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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GERD-BPD

Identifier Type: -

Identifier Source: org_study_id