Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants (INS-1)
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| ClinicalTrials.gov Identifier: NCT00349726 |
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Recruitment Status :
Completed
First Posted : July 10, 2006
Last Update Posted : June 20, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Retinopathy of Prematurity Bronchopulmonary Dysplasia (BPD) | Drug: Inositol lower volume Drug: Inositol higher volume Drug: Placebo lower volume Drug: Placebo higher volume | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 74 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants |
| Study Start Date : | June 2006 |
| Actual Primary Completion Date : | December 2007 |
| Actual Study Completion Date : | December 2007 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Inositol low volume
Single dose of intravenous inositol 5%, 60 mg/kg (1.2ml/kg) given over 20 minutes
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Drug: Inositol lower volume
60 mg/kg (1.2ml/kg) of myo-inositol 5% given intravenously over 20 minutes. |
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Experimental: Inositol high volume
Single dose of intravenous inositol 5%, 120 mg/kg (2.4ml/kg) given over 20 minutes
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Drug: Inositol higher volume
120 mg/kg (2.4ml/kg) of myo-inositol 5% given intravenously over 20 minutes. |
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Placebo Comparator: Placebo low volume
Placebo (5% glucose) at a volume equal to 60 mg/kg (1.2 ml/kg) given via IV over 20 minutes.
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Drug: Placebo lower volume
60 mg/kg (1.2ml/kg) of glucose 5% given intravenously over 20 minutes. |
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Placebo Comparator: Placebo high volume
Placebo (5% glucose) at a volume equal to 120 mg/kg (2.4 ml/kg) given via IV over 20 minutes
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Drug: Placebo higher volume
120 mg/kg (2.4ml/kg) of glucose 5% given intravenously over 20 minutes. |
- Population pharmacokinetics [ Time Frame: 0-100 hours following infusion ]
- Adverse events during and following infusion, using a neonatal toxicity classification [ Time Frame: Until discharge ]
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| Ages Eligible for Study: | 3 Days to 6 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349726
| United States, Connecticut | |
| Yale University | |
| New Haven, Connecticut, United States, 06504 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| RTI International | |
| Durham, North Carolina, United States, 27705 | |
| Duke University | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75235 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84108 | |
| Principal Investigator: | 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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NICHD Neonatal Research Network Pharmacokinetics Inositol |
Very Low Birth Weight (VLBW) Extremely Low Birth Weight (ELBW) Prematurity |
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Bronchopulmonary Dysplasia Retinopathy of Prematurity Premature Birth Birth Weight Retinal Diseases Eye Diseases Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Body Weight Ventilator-Induced Lung Injury |
Lung Injury Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases Inositol Vitamin B Complex Vitamins Micronutrients Physiological Effects of Drugs |