The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia (GERD-BPD)
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 19, 2009 | ||||||||
| Last Updated Date | November 9, 2010 | ||||||||
| Start Date ICMJE | June 2009 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Evaluate the efficacy of fundoplication in premature infants with GERD and BPD. [ Time Frame: Three months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00926276 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia | ||||||||
| Official Title ICMJE | The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia (BPD). | ||||||||
| Brief Summary | The purpose of this study is to evaluate the efficacy of fundoplication in premature infants with GERD and BPD. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Fundoplication
Fundoplication |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 24 Weeks to 1 Year | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00926276 | ||||||||
| Other Study ID Numbers ICMJE | GERD-BPD | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | KuoJen Tsao, MD, Assistant Professor of Pediatric Surgery, University of Texas Medical School at Houston | ||||||||
| Study Sponsor ICMJE | The University of Texas Health Science Center, Houston | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | The University of Texas Health Science Center, Houston | ||||||||
| Verification Date | November 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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