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

NCT00926276 | Completed Phase 4

• 1 other identifier: GERD-BPD
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastroesophageal Reflux Disease; Bronchopulmonary Dysplasia

Keywords

Gastroesophageal Reflux Disease (GERD); Bronchopulmonary Dysplasia (BPD); Fundoplication

Outcome Measures

Primary Outcomes (1)

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

  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.

  Six months

Study Arms (2)

Surgical Treatment Group-Fundoplication

ACTIVE COMPARATOR

Re-evaluated 1 month post-op Re-evaluated 2 months post-op

Procedure: Fundoplication

Medical Therapy

ACTIVE COMPARATOR

Treated by primary clinician for GERD Re-evaluated 1 month Proceed to Fundoplication if GERD persist by pH-MII Re-evaluated at 2 months (1 month post-op) Worsening BPD will be given option of immediate surgery

Procedure: Fundoplication

Interventions

Fundoplication PROCEDURE

Fundoplication

Medical Therapy; Surgical Treatment Group-Fundoplication

Eligibility Criteria

• Age: 24 Weeks - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

UT-Houston Pediatric Surgery & Memorial Hermann Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Bronchopulmonary Dysplasia

Interventions

Fundoplication

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• KuoJen Tsao, M.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Pediatric Surgery

Study Record Dates

• First Submitted: June 19, 2009
• First Posted: June 23, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: December 11, 2014

Record last verified: 2014-12

Locations

US (1)