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

This study is currently recruiting participants.
Verified November 2010 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00926276
First received: June 19, 2009
Last updated: November 9, 2010
Last verified: November 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Gastroesophageal Reflux Disease
Bronchopulmonary Dysplasia
 Procedure: Fundoplication
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia (BPD).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Evaluate the efficacy of fundoplication in premature infants with GERD and BPD. [ Time Frame: Three months ] [ Designated as safety issue: No ]

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. [ Time Frame: Six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Surgical Treatment Group-Fundoplication
Re-evaluated 1 month post-op Re-evaluated 2 months post-op
 Procedure: Fundoplication
Fundoplication
Active Comparator: 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
 Procedure: Fundoplication
Fundoplication

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.

  Eligibility

Ages Eligible for Study:   24 Weeks to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00926276

Contacts
Contact: KuoJen Tsao, M.D. 713 500-7327 KuoJen.Tsao@uth.tmc.edu
Contact: Marcia L. Kerr, R.N. 713 500-7363 Marcia.L.Kerr@uth.tmc.edu

Locations
United States, Texas
UT-Houston Pediatric Surgery & Memorial Hermann Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: KuoJen Tsao, M.D.     713-500-7327     KuoJen.Tsao@uth.tmc.edu    
Contact: Marcia L Kerr, R.N.     713 500-7363     Marcia.L.Kerr@uth.tmc.edu    
Principal Investigator: KuoJen Tsao, M.D.            
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: KuoJen Tsao, M.D. The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: KuoJen Tsao, MD, Assistant Professor of Pediatric Surgery, University of Texas Medical School at Houston
ClinicalTrials.gov Identifier: NCT00926276     History of Changes
Other Study ID Numbers: GERD-BPD
Study First Received: June 19, 2009
Last Updated: November 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Gastroesophageal Reflux Disease (GERD)
Bronchopulmonary Dysplasia (BPD)
Fundoplication

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Gastroesophageal Reflux
Hyperplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
 Infant, Newborn, Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013