Phase 3 N=18 Randomized Double-blind Treatment

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

Gastroesophageal Reflux

Bottom Line

View on ClinicalTrials.gov: NCT00131248 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2014

Primary outcome: Primary: Bradycardia Episodes/Day — 4.6; 3.6 episodes per day

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Metaclopramide (Drug); Ranitidine (Drug); placebo (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Bradycardia Episodes/Day	4.6; 3.6	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00131248). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.