Overview

Medical Treatment for Gastroesophageal Reflux Disease (GERD) in Preterm Infants

Status:
Completed
Trial end date:
2008-03-01
Target enrollment:
0
Participant gender:
All
Summary
Study Question: In premature infants with apnea and/or bradycardia attributed to gastroesophageal reflux disease (GERD), does treatment with medications (acid blockers and motility agents), compared to placebo, reduce the frequency of apnea and bradycardia? Background: Many clinicians believe that apnea and bradycardia in preterm infants may be caused by gastroesophageal reflux (GER), however, studies have failed to demonstrate even a temporal association between episodes of GER and apnea. There have been no prospective randomized trials of treatment for GERD in preterm infants with apnea or other symptoms attributed to GER. Methods: A randomized, cross-over study will be performed. This cross-over design will provide the patient's clinician with unbiased information about the patient's response to treatment. The clinician can use this information in deciding whether or not to continue treatment after the two-week study period.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston
Treatments:
Metoclopramide
Ranitidine
Ranitidine bismuth citrate
Criteria
Inclusion Criteria:

- Premature infants < 37 weeks gestation at birth; currently less than 44 weeks
postmenstrual age.

- Not currently receiving mechanical ventilation

- Clinical diagnosis of GER and apnea/bradycardia suspected by the clinicians to be
related to the GER. (Supporting diagnostic test information, such as upper
gastrointestinal series [UGI] studies and pH probes will be recorded but not required
for study enrollment.)

- Attending physician plan to begin anti-reflux medications

- Infants may be included in the study if they are on continuous positive airway
pressure (CPAP) or methylxanthines for treatment of apnea only if the clinicians are
willing to maintain the same regimen for the two-week duration of the study.

- Stable feeding regimen

Exclusion Criteria:

- History of congenital neurological defect

- Imminent discharge (within 2 weeks)

- Parent refusal