Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-12-31

Brief Summary

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This pilot study was a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following a single intravenous dose of inositol. Based on previous studies, the premise is that maintaining inositol concentrations similar to those occurring naturally in utero will reduce the rates of ROP and bronchopulmonary dysplasia in premature infants. The objective was to evaluate the single-dose pharmacokinetics and safety of different amounts of intravenous myo-inositol (provided by Ross Products Division, Abbott Laboratories) in very low birth weight neonates, in preparation for a future Phase III multi-center randomized controlled trial. This study enrolled 74 infants at high risk for retinopathy at 9 NICHD Neonatal Research Network sites, and randomly assigned them to receive either 60mg/kg of 5% inositol, 120 mg/kg of 5% inositol, 60 mg/kg of 5% glucose (the placebo), or 120 mg/kg of 5% glucose.

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Detailed Description

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Retinopathy of prematurity (ROP) is an abnormal growth of the blood vessels in the eye that occurs primarily in very premature infants. Eye development occurs normally in the womb; in infants born prematurely, however, the blood vessels must finish developing outside the protective environment of the uterus. Retinopathy of prematurity (also known as retrolental fibroplasia) is a leading cause of blindness and other vision impairments (myopia, strabismus, and amblyopia) in children, both in developed and developing countries.

Inositol is a naturally-occurring sugar alcohol produced by the placenta and is present in high levels in fetal blood throughout pregnancy in humans and other animals. Serum levels fall rapidly after birth, although this fall is moderated in infants who receive breast milk. Two randomized trials have shown that intravenous inositol supplementation in the first week significantly reduced death, bronchopulmonary dysplasia (BPD), and retinopathy. One study of oral supplements was less convincing, but also supported reduction of retinopathy.

This pilot study evaluated the half-life pharmacokinetics of a single-dose of myo-inositol (provided by Ross Products Division, Abbott Laboratories) in very low birth weight infants, looking at changes in blood and urine inositol levels. The premise is that maintaining inositol concentrations similar to those occurring naturally in utero will reduce the rates of retinopathy and bronchopulmonary dysplasia in premature infants. Results from this study will be used to select the doses for a subsequent multi-dose pilot study, and for the planned large multi-center trials.

In this study, nine NICHD Neonatal Research Network sites enrolled 74 infants of less than 30 weeks gestation and randomly assigned them to receive either 60mg/kg of 5% inositol, 120 mg/kg of 5% inositol, 60 mg/kg of 5% glucose (the placebo), or 120 mg/kg of 5% glucose. Concentrations of inositol were measured in both blood and urine to determine population pharmacokinetic parameters for these infants.

Stratification: Enrolled infants were stratified by age with 37 infants of 23 0/7 to 26 6/7 weeks in one group and 37 infants of 27 0/7 to 29 6/7 weeks in a second group.

Conditions

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Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Retinopathy of Prematurity Bronchopulmonary Dysplasia (BPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Inositol low volume

Single dose of intravenous inositol 5%, 60 mg/kg (1.2ml/kg) given over 20 minutes

Group Type EXPERIMENTAL

Inositol lower volume

Intervention Type DRUG

60 mg/kg (1.2ml/kg) of myo-inositol 5% given intravenously over 20 minutes.

Inositol high volume

Single dose of intravenous inositol 5%, 120 mg/kg (2.4ml/kg) given over 20 minutes

Group Type EXPERIMENTAL

Inositol higher volume

Intervention Type DRUG

120 mg/kg (2.4ml/kg) of myo-inositol 5% given intravenously over 20 minutes.

Placebo low volume

Placebo (5% glucose) at a volume equal to 60 mg/kg (1.2 ml/kg) given via IV over 20 minutes.

Group Type PLACEBO_COMPARATOR

Placebo lower volume

Intervention Type DRUG

60 mg/kg (1.2ml/kg) of glucose 5% given intravenously over 20 minutes.

Placebo high volume

Placebo (5% glucose) at a volume equal to 120 mg/kg (2.4 ml/kg) given via IV over 20 minutes

Group Type PLACEBO_COMPARATOR

Placebo higher volume

Intervention Type DRUG

120 mg/kg (2.4ml/kg) of glucose 5% given intravenously over 20 minutes.

Interventions

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Inositol lower volume

60 mg/kg (1.2ml/kg) of myo-inositol 5% given intravenously over 20 minutes.

Intervention Type DRUG

Inositol higher volume

120 mg/kg (2.4ml/kg) of myo-inositol 5% given intravenously over 20 minutes.

Intervention Type DRUG

Placebo lower volume

60 mg/kg (1.2ml/kg) of glucose 5% given intravenously over 20 minutes.

Intervention Type DRUG

Placebo higher volume

120 mg/kg (2.4ml/kg) of glucose 5% given intravenously over 20 minutes.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 23 0/7 to 26 6/7 weeks gestational age (36 infants) or
* 27 0/7 to 29 6/7 weeks gestational age (36 infants)
* 600-1500 grams birth weight
* No enteral feedings since birth at enrollment
* 3-6 days (25-132 hours) postnatal age

Note: Because of the high mortality expected in this population (15-20%), the study design (originally for 72 infants) required recruitment of a replacement subject if any infant failed to complete the four blood samples during the first week of the study.

Exclusion Criteria

* Major congenital anomalies
* Moribund or not to be provided continued support
* Renal failure suspected (creatinine \>2.5 with oliguria)
* Exchange transfusion received or expected to receive

Minimum Eligible Age

3 Days

Maximum Eligible Age

6 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abbot R. Laptook, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University, Women & Infants Hospital of Rhode Island

Michele C. Walsh, MD MS

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University, Rainbow Babies and Children's Hospital

Ronald N. Goldberg, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Brenda B. Poindexter, MD MS

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Abhik Das, PhD

Role: PRINCIPAL_INVESTIGATOR

RTI International

Kristi L. Watterberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Dale L. Phelps, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Pablo J. Sanchez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas, Southwestern Medical Center at Dallas

Seetha Shankaran, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Richard A. Ehrenkranz, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Roger G. Faix, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Barbara J. Stoll, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Kurt Schibler, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Krisa P. Van Meurs, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Waldemar A. Carlo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Kathleen A. Kennedy, MD MPH

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Ivan D. Frantz, III, MD

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

RTI International

Durham, North Carolina, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Site Status

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Site Status

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States