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



Status:Completed
Conditions:Bronchitis, Gastroesophageal Reflux Disease , Hematology
Therapuetic Areas:Gastroenterology, Hematology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any - 1
Updated:2/7/2015
Start Date:June 2009
End Date:June 2013
Contact:KuoJen Tsao, M.D.
Email:KuoJen.Tsao@uth.tmc.edu
Phone:713 500-7327

Use our guide to learn which trials are right for you!

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.

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
We found this trial at
1
site
?
mi
from
Houston, TX
Click here to add this to my saved trials