Status:
COMPLETED
Medical Treatment for Gastroesophageal Reflux Disease (GERD) in Preterm Infants
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
1-6 years
Phase:
PHASE3
Brief 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 t...
Detailed Description
Study Question: In premature infants with apnea and/or bradycardia attributed to GERD, does treatment with H2 blockers and prokinetic agents, compared to placebo, reduce the frequency of apnea and bra...
Eligibility Criteria
Inclusion
- 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
- History of congenital neurological defect
- Imminent discharge (within 2 weeks)
- Parent refusal
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00131248
Start Date
April 1 2004
End Date
March 1 2008
Last Update
January 15 2014
Active Locations (1)
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1
Memorial Hermann Children's Hospital
Houston, Texas, United States, 77030