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NCT00131248 · ClinicalTrials.gov registry record · Phase 3
Medical Treatment for Gastroesophageal Reflux Disease (GERD) in Preterm Infants
A Phase 3 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 3
- Development phase
- 18
- Enrollment target
NCT00131248: Completed Phase 3 study, sponsored by The University of Texas Health Science Center, Houston.
NCT00131248 is a Phase 3 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 18 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00131248, a Phase 3 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 18 participants
- Enrollment target
Study 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.
Interventions
- DRUG placebo
- DRUG Ranitidine
- DRUG Metaclopramide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2004-04 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
What the finished NCT00131248 record still lists
NCT00131248 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00131248 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00131248 about?
NCT00131248 is a clinical study titled "Medical Treatment for Gastroesophageal Reflux Disease (GERD) in Preterm Infants". 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 ...
What is the current status of trial NCT00131248?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 18 participants. The study started on 2004-04. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00131248?
The interventions under investigation include: placebo (DRUG), Ranitidine (DRUG), Metaclopramide (DRUG).
Who is sponsoring clinical trial NCT00131248?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00131248's enrollment target sits among peer trials
18 1970th of 2000 higher than 30 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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