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Inositol to Reduce Retinopathy of Prematurity
Recruiting
I'm InterestedTrial ID: NCT01954082
Purpose
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.
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
Eligibility
Inclusion Criteria:
- Inborn or out born infants of either gender or any race with best obstetrical estimate
of gestation <28 weeks (27 6/7 weeks and younger). Gestational age will be determined
by best obstetrical estimate using the hierarchy of best obstetrical estimate using
early ultrasound dating, maternal menstrual dating confirmed by examination, or
neonatal gestational age assessment by physical examination.
- Alive at 12 hours.
- Age in hours up to 72 hours, although we will seek enrollment as early as feasible
after consent and 12 hours.
- Informed consent signed and dated by parent and/or guardian, which includes likelihood
of completing follow-up ophthalmic examinations as an outpatient, and long-term
follow-up.
Exclusion Criteria
- Major congenital malformations
- Congenital malformations of the eye identified prior to randomization.
- Overt evidence of intrauterine congenital infections ("TORCH") or life threatening
impairment of renal, hepatic, or cardiac function (considered moribund).
Intervention(s):
drug: Placebo
drug: myo-Inositol 5% Injection
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Krisa P. Van Meurs, MD
650-723-5711