Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by The University of Texas Health Science Center, Houston.
Recruitment status was  Recruiting
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

June 19, 2009
November 9, 2010
June 2009
June 2012   (final data collection date for primary outcome measure)
Evaluate the efficacy of fundoplication in premature infants with GERD and BPD. [ Time Frame: Three months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00926276 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia
The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia (BPD).

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastroesophageal Reflux Disease
  • Bronchopulmonary Dysplasia
Procedure: Fundoplication
Fundoplication
  • Active Comparator: Surgical Treatment Group-Fundoplication
    Re-evaluated 1 month post-op Re-evaluated 2 months post-op
    Intervention: Procedure: 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
    Intervention: Procedure: Fundoplication
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
June 2013
June 2012   (final data collection date for primary outcome measure)

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
Both
24 Weeks to 1 Year
No
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
United States
 
NCT00926276
GERD-BPD
No
KuoJen Tsao, MD, Assistant Professor of Pediatric Surgery, University of Texas Medical School at Houston
The University of Texas Health Science Center, Houston
Not Provided
Principal Investigator: KuoJen Tsao, M.D. The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP