At a glance
ClinicalIndex Comparison Record- ✓Premature birth <37 weeks gestation; currently <44 weeks postmenstrual age
- ✓Not currently on mechanical ventilation
- ✓Clinical diagnosis of GER with apnea/bradycardia suspected to be GER-related
- ✓Attending physician plans to start anti-reflux medications
- ✕History of congenital neurological defect
- ✕Imminent discharge within 2 weeks
- ✕Parental refusal
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cross-over Trial of Medical Treatment for GERD in Preterm Infants
In Brief
A Phase 3 clinical trial evaluating Metaclopramide, Ranitidine, and 1 other intervention for Gastroesophageal Reflux. Completed, enrolled 18 participants across 1 site.
Detailed 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.