Trial · NCT00131248
Medical Treatment for Gastroesophageal Reflux Disease (GERD) in Preterm Infants
NCT00131248, Phase 3, Completed, The University of Texas Health Science Center, Houston; results first posted 2014-01-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Medical Treatment for Gastroesophageal Reflux Disease (GERD) in Preterm Infants. Trials, record NCT00131248. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00131248
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Medical Treatment for Gastroesophageal Reflux Disease (GERD) in Preterm Infants
- NCT number
- NCT00131248
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 18 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Gastroesophageal Reflux
- Interventions
- Metaclopramide, Ranitidine, placebo
- First posted
- 2005-08-17
- Last updated
- 2014-01-15
- Results first posted
- 2014-01-15
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bradycardia Episodes/Day | 7 days |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Bradycardia Episodes/Day | 7 days | 18 participants originally enrolled, 1 withdrew, leaving 17 participants analyzed. | episodes per day | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bradycardia Episodes/Day | Medications | 4.6 | Standard Deviation 3.1 | episodes per day | |
| Bradycardia Episodes/Day | Placebo | 3.6 | Standard Deviation 2.7 | episodes per day |
Source ClinicalTrials.gov
Participant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Intervention 1 (3-day Course) | STARTED | Medications, Placebo, Medications (Group 1) | 9 | |
| Intervention 1 (3-day Course) | STARTED | Placebo, Medications, Placebo (Group 2) | 9 | |
| Intervention 1 (3-day Course) | COMPLETED | Medications, Placebo, Medications (Group 1) | 8 | |
| Intervention 1 (3-day Course) | COMPLETED | Placebo, Medications, Placebo (Group 2) | 9 | |
| Intervention 1 (3-day Course) | NOT COMPLETED | Medications, Placebo, Medications (Group 1) | 1 | |
| Intervention 1 (3-day Course) | NOT COMPLETED | Placebo, Medications, Placebo (Group 2) | 0 | |
| Washout (24 Hour) | STARTED | Medications, Placebo, Medications (Group 1) | 8 | |
| Washout (24 Hour) | STARTED | Placebo, Medications, Placebo (Group 2) | 9 | |
| Washout (24 Hour) | COMPLETED | Medications, Placebo, Medications (Group 1) | 8 | |
| Washout (24 Hour) | COMPLETED | Placebo, Medications, Placebo (Group 2) | 9 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Medications | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Medications | 0 | 17 |
| Total, other adverse events | Placebo | 0 | 17 |
| Total, serious adverse events | Medications | 0 | 17 |
| Total, serious adverse events | Placebo | 0 | 17 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19540518 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Medications vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00131248
GET https://conductscience.org/api/trials/v1/NCT00131248/flow?page=2