Medical Treatment for Gastroesophageal Reflux Disease (GERD) in Preterm Infants
Status:
Completed
Trial end date:
2008-03-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston