Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants

NCT00349726 | Completed Phase 2 DMC FDA Drug

• 21 other identifiers: NICHD-NRN-0036-1U10HD021364U10HD021373U10HD021385U10HD027851U10HD027853U10HD027856U10HD027871U10HD027880U10HD027904U10HD034216U10HD036790U10HD040492U10HD040689U10HD053089U10HD053109U10HD053119U10HD053124UL1RR024139UL1RR025744UL1RR024979
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

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

Keywords

NICHD Neonatal Research Network; Pharmacokinetics; Inositol; Very Low Birth Weight (VLBW); Extremely Low Birth Weight (ELBW); Prematurity

Outcome Measures

Primary Outcomes (1)

• Population pharmacokinetics

  0-100 hours following infusion

Secondary Outcomes (1)

• Adverse events during and following infusion, using a neonatal toxicity classification

  Until discharge

Study Arms (4)

Inositol low volume

EXPERIMENTAL

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

Drug: Inositol lower volume

Inositol high volume

EXPERIMENTAL

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

Drug: Inositol higher volume

Placebo low volume

PLACEBO COMPARATOR

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

Drug: Placebo lower volume

Placebo high volume

PLACEBO COMPARATOR

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

Drug: Placebo higher volume

Interventions

Inositol lower volume DRUG

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

Inositol low volume

Inositol higher volume DRUG

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

Inositol high volume

Placebo lower volume DRUG

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

Placebo low volume

Placebo higher volume DRUG

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

Placebo high volume

Eligibility Criteria

• Age: 3 Days - 6 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• /7 to 26 6/7 weeks gestational age (36 infants) or
• /7 to 29 6/7 weeks gestational age (36 infants)
• grams birth weight
• No enteral feedings since birth at enrollment
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NICHD Neonatal Research Network: lead
• National Eye Institute (NEI): collaborator
• National Center for Research Resources (NCRR): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (11)

Yale University

New Haven, Connecticut, 06504, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

RTI International

Durham, North Carolina, 27705, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

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

Cleveland, Ohio, 44106, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Links

• NICHD Neonatal Research Network

MeSH Terms

Conditions

Premature Birth; Retinopathy of Prematurity; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Abbot R. Laptook, MD

  Brown University, Women & Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

• Michele C. Walsh, MD MS

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

  PRINCIPAL INVESTIGATOR

• Ronald N. Goldberg, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Brenda B. Poindexter, MD MS

  Indiana University

  PRINCIPAL INVESTIGATOR

• Abhik Das, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

• Kristi L. Watterberg, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Dale L. Phelps, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Pablo J. Sanchez, MD

  University of Texas, Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

• Seetha Shankaran, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Richard A. Ehrenkranz, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Roger G. Faix, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Barbara J. Stoll, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Kurt Schibler, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Krisa P. Van Meurs, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Waldemar A. Carlo, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Kathleen A. Kennedy, MD MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Ivan D. Frantz, III, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2006
• First Posted: July 10, 2006
• Study Start: June 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

US (11)