Adults 12 Hours to 72 Hours, any sex, with Retinopathy of Prematurity (ROP). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Unfavorable Outcome, Defined as Severe Retinopathy of Prematurity (ROP) or Death Prior to Reaching Acute/Final ROP StatusPrimary· by 55 weeks PMA
Death is defined as from any cause before Acute/Final ROP status is determined. ROP was identified by routine ophthalmologic examinations beginning at the latter of 31 weeks PMA or 4-6 weeks chronologic age. The favorable ROP endpoint requires that no ROP, or only mild ROP has occurred in both eyes and the eyes have matured beyond the risk of developing Type 1 ROP (severity meeting criteria for surgical intervention). The unfavorable ROP endpoint requires that one or both eyes reach Type 1 ROP. When ROP did not resolve by the time of discharge, participants were followed as outpatients until r
Group
Value
95% CI
Myo-Inositol 5% Injection
91
5% Glucose(Dextrose)
66
Number of Participants With Bronchopulmonary Dysplasia (BPD)Secondary· 36 weeks PMA
BPD is defined as supplemental oxygen required to maintain an oxygenation saturation of \>90% at 36 weeks postmenstrual age (PMA) (NICHD physiologic definition).
Group
Value
95% CI
Myo-Inositol 5% Injection
159
5% Glucose(Dextrose)
165
Number of Participants With Bronchopulmonary Dysplasia (BPD) or Death From BPDSecondary· prior to 37 weeks PMA
BPD is defined as supplemental oxygen required to maintain an oxygenation saturation of \>90% at 36 weeks PMA (NICHD physiologic definition). Death from BPD prior to 37 weeks postmenstrual age (PMA) is defined when the cause of death is certified by the Center PI as BPD being the primary cause, or a significant co-contributing cause of death.
Group
Value
95% CI
Myo-Inositol 5% Injection
203
5% Glucose(Dextrose)
195
Number of Participants With All Cause Death Before Retinopathy of Prematurity (ROP) EndpointSecondary· by 55 weeks PMA age
Defined as death from any cause following randomization through primary study follow-up (up to 55 weeks postmenstrual age (PMA))
Group
Value
95% CI
Myo-Inositol 5% Injection
50
5% Glucose(Dextrose)
33
Number of Participants With Any Retinopathy of Prematurity (ROP)Secondary· by 55 weeks PMA
ROP was identified by routine ophthalmologic examinations beginning at the latter of 31 weeks PMA or 4-6 weeks chronologic age. Any ROP is defined as ROP of any severity that is observed on at least 2 independent examinations in either eye through the time that Acute/Final ROP status is reached (up to 55 weeks postmenstrual age (PMA)).
Group
Value
95% CI
Myo-Inositol 5% Injection
171
5% Glucose(Dextrose)
183
Number of Participants With Type 2 or More Severe Retinopathy of Prematurity (ROP)Secondary· by 55 weeks PMA
Defined as one or both eyes reaching Type 2 ROP (ETROP 2003) or the more severe Type 1 ROP (as defined previously) through the time that Acute/Final ROP status is reached (up to 55 weeks postmenstrual age (PMA)). Type 2 ROP is defined as (ETROP 2003): Stage 3 ROP without Plus Disease (i.e. Zone II) or Stage 1 or 2 ROP without Plus Disease (i.e. Zone I).
Group
Value
95% CI
Myo-Inositol 5% Injection
125
5% Glucose(Dextrose)
142
Number of Participants With Severe Intraventricular Hemorrhage (IVH)Secondary· by 28 days PMA
Severe IVH is defined as IVH Grades 3 or 4 on either side of the brain. The evaluation for IVH occurs early (within 28 days from birth) via a cranial sonogram and is classified as described by Papile.
Group
Value
95% CI
Myo-Inositol 5% Injection
51
5% Glucose(Dextrose)
50
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events will be recorded from treatment initiation until 7 days after the last dose of study drug, up to the earliest of 34 weeks post-menstrual age (PMA), 10 weeks chronologic age (CA), or discharge..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a Phase 3, randomized, double-masked, placebo-controlled study designed to determine the effectiveness of myo-Inositol 5% Injection to increase the incidence of survival without severe Retinopathy of Prematurity (ROP) through acute/final ROP determination up to 55 weeks postmenstrual age (PMA) in premature infants \<28 0/7 weeks' gestation.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Other recruiting trials for Retinopathy of Prematurity (ROP)
Currently open trials in the same condition.
NCT06717412 — Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy
· NA
· recruiting
NCT06694103 — The Effect of Two Non-Pharmacological Methods on Pain During Retinopathy Examination
· NA
· recruiting
NCT03253263 — A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
· Phase 2
· recruiting
Other NICHD Neonatal Research Network trials
Trials by the same sponsor.
NCT07417111 — Continued Pressure for Alveolar Protection (CPAP Trial)
· NA
· not yet recruiting
NCT06679855 — Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial
· Phase 3
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NICHD Neonatal Research Network
Last refreshed: 22 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01954082.