Inositol to Reduce Retinopathy of Prematurity
Public ClinicalTrials.gov record NCT01954082. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
INS-3: A Phase 3, Randomized, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Myo-Inositol 5% Injection to Increase Survival Without Severe Retinopathy of Prematurity (Reduce-ROP) in Extremely Premature Infants
Study identification
- NCT ID
- NCT01954082
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- NICHD Neonatal Research Network
- Network
- Enrollment
- 638 participants
Conditions and interventions
Conditions
Interventions
- Placebo Drug
- myo-Inositol 5% Injection Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Hours to 72 Hours
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 16, 2014
- Primary completion
- Dec 30, 2016
- Completion
- Dec 30, 2016
- Last update posted
- Mar 21, 2019
2014 – 2016
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| University of California - Los Angeles | Los Angeles | California | 90025 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| Emory University | Atlanta | Georgia | 30303 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Wayne State University | Detroit | Michigan | 48201 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| RTI International | Durham | North Carolina | 27705 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| Cincinnati Children's Medical Center | Cincinnati | Ohio | 45267 | — |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | — |
| Research Institute at Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Univeristy of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | — |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75235 | — |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01954082, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 21, 2019 · Synced May 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01954082 live on ClinicalTrials.gov.