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Inositol to Reduce Retinopathy of Prematurity (INS-3)

N

NICHD Neonatal Research Network

Status and phase

Terminated
Phase 3

Conditions

Retinopathy of Prematurity (ROP)

Treatments

Drug: Placebo
Drug: myo-Inositol 5% Injection

Study type

Interventional

Funder types

NETWORK
NIH

Identifiers

NCT01954082
U10HD053109 (U.S. NIH Grant/Contract)
U10HD021373 (U.S. NIH Grant/Contract)
U10HD027853 (U.S. NIH Grant/Contract)
U10HD068270 (U.S. NIH Grant/Contract)
U10HD021364 (U.S. NIH Grant/Contract)
U10HD027880 (U.S. NIH Grant/Contract)
U10HD036790 (U.S. NIH Grant/Contract)
U10HD027856 (U.S. NIH Grant/Contract)
U10HD053089 (U.S. NIH Grant/Contract)
NICHD-NRN-0053
U10HD040492 (U.S. NIH Grant/Contract)
U10HD027851 (U.S. NIH Grant/Contract)
U10HD068244 (U.S. NIH Grant/Contract)
U10HD040689 (U.S. NIH Grant/Contract)
U10HD068284 (U.S. NIH Grant/Contract)
U10HD068263 (U.S. NIH Grant/Contract)
U10HD034216 (U.S. NIH Grant/Contract)
U10HD021385 (U.S. NIH Grant/Contract)
U10HD027904 (U.S. NIH Grant/Contract)
U10HD068278 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Approximately 1760 infants are to be enrolled at approximately 18 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network (NRN) Centers (approximately 44 sites) in the United States. Infants meeting the study selection criteria and for whom informed consent is obtained will be randomized to receive either 80 mg inositol/kg/day or placebo, administered in divided doses every 12 hours (40 mg/kg/dose). Study drug will be administered daily, starting within 12 to 72 hours of birth and continued until the earliest of 34 weeks PMA, 10 weeks chronologic age, or the time of hospital discharge or transfer. Inositol or placebo will be administered IV until enteral feedings reach 120ml/kg/day (or sooner if the infant is no longer receiving IV fluids), at which time the same dose and formulation will be administered enterally every 12 hours.

For publication purposes, the analysis of the primary efficacy outcome will consider the entire study population. In support of a new drug application (NDA) for use of myo-Inositol 5% Injection to increase survival without severe ROP through the determination of acute/final ROP status, the analysis of the primary efficacy outcome will be conducted for the entire study population and separately within pre-specified regulatory sub-studies created by administratively splitting infants enrolled at each study center into two sub-studies.

Assessments performed during the study include customary newborn intensive care procedures including repeat eye examinations until ROP status is final (which often extends after discharge), measurements of growth, cranial ultrasounds or other imaging per usual practice, and the collection of clinical diagnoses throughout hospitalization to evaluate other common morbidities of extreme preterm birth. Adverse events will be recorded from time of treatment initiation until 7 days after the last dose of study drug, and concurrent medications will be recorded from 24 hours prior to randomization until 7 days after the last dose of study drug or until discharge or transfer if sooner. Using the separate NICHD Follow-up protocol, longer term data will be collected at 22-26 months corrected age, including growth, neurodevelopmental testing, overall health status, rehospitalizations, surgeries and diagnoses, including ophthalmic diagnoses and treatments since discharge.

Enrollment

638 patients

Sex

All

Ages

12 to 72 hours old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

638 participants in 2 patient groups, including a placebo group

myo-Inositol 5% Injection
Experimental group
Description:
Within 12-72 hours of birth, infants will receive 80 mg myo-inositol 5% Injection per kilogram per day, administered in divided doses every 12 hours (40 mg/kg/dose). Study drug will be administered daily and continued until the earliest of 34 completed weeks PMA, 10 weeks (70 days) chronologic age, or the time of discharge. myo-Inositol 5% Injection will be administered IV until enteral feedings are established, at which time the same dose and formulation will be administered enterally every 12 hours.
Treatment:
Drug: myo-Inositol 5% Injection
5% glucose(dextrose)
Placebo Comparator group
Description:
Within 12-72 hours of birth, infants will receive 80 mg 5% glucose(dextrose) USP for intravenous infusion per kilogram per day, administered in divided doses every 12 hours (40 mg/kg/dose). Study drug will be administered daily and continued until the earliest of 34 completed weeks PMA, 10 weeks (70 days) chronologic age, or the time of discharge. myo-Inositol 5% Injection will be administered IV until enteral feedings are established, at which time the same dose and formulation will be administered enterally every 12 hours.
Treatment:
Drug: Placebo

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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