Trial · NCT01238471
Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity: A Randomized and Prospective Study
NCT01238471, Phase 1, Phase 2, Completed, Rambam Health Care Campus; results first posted 2014-06-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity: A Randomized and Prospective Study. Trials, record NCT01238471. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01238471
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Propranolol Versus Placebo for Early Stages of Retinopathy of Prematurity: A Randomized and Prospective Study
- NCT number
- NCT01238471
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Rambam Health Care Campus
- Conditions
- Retinopathy of Prematurity
- Interventions
- propranolol, sucrose 5%
- First posted
- 2010-11-10
- Last updated
- 2014-06-26
- Results first posted
- 2014-06-10
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Regression of Retinopathy of Prematurity (ROP) in Premature Infants by Propranolol Therapy | propranolol therapy for up 4 weeks | If ROP regresses without the need for treatment (laser and/or CRYO), this will be considered a favorable outcome. On the other hand, if ROP progresses to require treatment, it will be regarded as an unfavorable outcome. Evidence for regression of ROP was observed by serial retinal examinations performed by ophthalmologists as well as by reduction for the need of invasive interventions such as laser photocoagulation of disease areas in the retina. |
| Secondary | Safety of Propranolol Therapy in Premature Infants | 4 weeks of propranolol therapy in premature infants | Close monitoring for possible side effects of propranolol in premature infants |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Regression of Retinopathy of Prematurity (ROP) in Premature Infants by Propranolol Therapy | propranolol therapy for up 4 weeks | cases | NUMBER | |
| SECONDARY | Safety of Propranolol Therapy in Premature Infants | 4 weeks of propranolol therapy in premature infants |
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 |
|---|---|---|---|---|---|
| Regression of Retinopathy of Prematurity (ROP) in Premature Infants by Propranolol Therapy | Propranolol | 4 | cases | ||
| Regression of Retinopathy of Prematurity (ROP) in Premature Infants by Propranolol Therapy | Oral Sucrose 5% | 8 | cases |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Propranolol | 10 | |
| Overall Study | STARTED | Oral Sucrose 5% | 10 | |
| Overall Study | COMPLETED | Propranolol | 10 | |
| Overall Study | COMPLETED | Oral Sucrose 5% | 10 | |
| Overall Study | NOT COMPLETED | Propranolol | 0 | |
| Overall Study | NOT COMPLETED | Oral Sucrose 5% | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | bradycardia | Cardiac disorders | Propranolol | 0 | 10 | 0 |
| serious | bradycardia | Cardiac disorders | Oral Sucrose 5% | 0 | 10 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Propranolol | ||
| Total, all-cause mortality | Oral Sucrose 5% | ||
| Total, other adverse events | Propranolol | 0 | 10 |
| Total, other adverse events | Oral Sucrose 5% | 0 | 10 |
| Total, serious adverse events | Propranolol | 0 | 10 |
| Total, serious adverse events | Oral Sucrose 5% | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| Propranolol vs Oral Sucrose 5%: 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/NCT01238471
GET https://conductscience.org/api/trials/v1/NCT01238471/registered