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

Primary Purpose

Gastroesophageal Reflux Disease, Bronchopulmonary Dysplasia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fundoplication
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring Gastroesophageal Reflux Disease (GERD), Bronchopulmonary Dysplasia (BPD), Fundoplication

Eligibility Criteria

24 Weeks - 1 Year (Child)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Surgical Treatment Group-Fundoplication

Medical Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Evaluate the efficacy of fundoplication in premature infants with GERD and BPD.

Secondary Outcome Measures

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.

Full Information

First Posted
June 19, 2009
Last Updated
December 9, 2014
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT00926276
Brief Title
The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia
Acronym
GERD-BPD
Official Title
The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia (BPD).
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Bronchopulmonary Dysplasia
Keywords
Gastroesophageal Reflux Disease (GERD), Bronchopulmonary Dysplasia (BPD), Fundoplication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical Treatment Group-Fundoplication
Arm Type
Active Comparator
Arm Description
Re-evaluated 1 month post-op Re-evaluated 2 months post-op
Arm Title
Medical Therapy
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Fundoplication
Intervention Description
Fundoplication
Primary Outcome Measure Information:
Title
Evaluate the efficacy of fundoplication in premature infants with GERD and BPD.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
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.
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KuoJen Tsao, M.D.
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT-Houston Pediatric Surgery & Memorial Hermann Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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