Clinical trial NCT00926276: The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia
Official title: The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia (BPD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Bronchopulmonary Dysplasia
Keywords: Gastroesophageal Reflux Disease (GERD)
Bronchopulmonary Dysplasia (BPD)
Fundoplication
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2009-06-23
Enrollment: 2
Sex: ALL
Minimum age (years): 24
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Evaluate the efficacy of fundoplication in premature infants with GERD and BPD.
timeFrame: Three months
Secondary outcomes:
measure: 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.
timeFrame: Six months
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT-Houston Pediatric Surgery & Memorial Hermann Children's Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: KuoJen Tsao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: