Status:
COMPLETED
Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Eye Institute (NEI)
National Center for Research Resources (NCRR)
Conditions:
Infant, Newborn
Infant, Low Birth Weight
Eligibility:
All Genders
3-6 years
Phase:
PHASE2
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) fo...
Detailed Description
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 pre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00349726
Start Date
June 1 2006
End Date
December 1 2007
Last Update
June 20 2017
Active Locations (11)
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1
Yale University
New Haven, Connecticut, United States, 06504
2
Indiana University
Indianapolis, Indiana, United States, 46202
3
Wayne State University
Detroit, Michigan, United States, 48201
4
University of New Mexico
Albuquerque, New Mexico, United States, 87131