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Completed

NCT Number: NCT00926276

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fundoplication

Procedure

Fundoplication

Primary outcomes

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

    Time frame: Three months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Acronym: GERD-BPD

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 23, 2009
Registry last updated
Dec 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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