Iron Status and Myelination in Premature Infants
Not Applicable
Completed
- Conditions
- Neurodevelopmental Outcome
- Registration Number
- NCT00684697
- Lead Sponsor
- University of Rochester
- Brief Summary
Premature infants with iron deficiency if supplemented with more elemental iron than the routine 2mg/kg/day will have improved brain development.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Babies less than or equal to 33 weeks gestational age
Exclusion Criteria
- Infants with cranio-facial malformations
- Torch infections
- Infants with hearing disorders
- Infants receiving erythropoietin
- Infants with subnormal vitamin E levels
- Infants with severe anemia
- Infants who are not on full feeds
- Infant with in-utero exposure to cocaine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method mean interpeak latency Auditory Neural Myelination 43-45 weeks PMA This will be measured using auditory brain stem response.
mean visual neural myelination 43-45 weeks PMA Visual myelination will be evaluated by visual evoked response.
- Secondary Outcome Measures
Name Time Method number of participants with executed function 3-5 years Using a standardize test.
Trial Locations
- Locations (1)
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of Rochester Medical Center🇺🇸Rochester, New York, United States