UT-Houston Pediatric Surgery & Memorial Hermann Children's Hospital
Houston, Texas, 77030, United States
NCT Number: NCT00926276
The purpose of this study is to evaluate the efficacy of fundoplication in premature infants with GERD and BPD.
Looking for future studies?
Notify Me24 week–1 year
All sexes
Interventional
Phase 4
Houston, Texas, 77030, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fundoplication
Time frame: Three months
Time frame: Six months
The University of Texas Health Science Center, Houston
Other
The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia (BPD).
Acronym: GERD-BPD
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.
Published trials that share one or more normalized conditions with this study.
NCT07560787
Body Weight, Deglutition Disorders
Van, Turkey (Türkiye)
View Trial DetailsNCT05107219
Barrett Esophagus, Deglutition Disorders
Scottsdale, Arizona, United States
View Trial DetailsNCT06585176
Deglutition Disorders, Digestive System Diseases
Xiamen, Fujian, China
View Trial DetailsNCT06945237
Deglutition Disorders, Digestive System Diseases
Shanghai, Shanghai Municipality, China
View Trial Details