Inositol to Reduce Retinopathy of Prematurity



Status:Terminated
Conditions:Ocular, Ocular, Women's Studies
Therapuetic Areas:Ophthalmology, Reproductive
Healthy:No
Age Range:Any
Updated:3/24/2019
Start Date:April 17, 2014
End Date:December 31, 2016

Use our guide to learn which trials are right for you!

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

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.

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.

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).
We found this trial at
19
sites
?
mi
from
Columbus, OH
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
3040 East Cornwallis RoadTriangle
Durham, North Carolina 27705
?
mi
from
Durham, NC
Click here to add this to my saved trials
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
?
mi
from
Durham, NC
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
?
mi
from
Houston, TX
Click here to add this to my saved trials
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Providence, RI
Click here to add this to my saved trials
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Cincinnati, Ohio 45267
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials