Iron Status and Myelination in Premature Infants

University of Rochester100 enrolled

Overview

Premature infants with iron deficiency if supplemented with more elemental iron than the routine 2mg/kg/day will have improved brain development.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

100

Conditions

Neurodevelopmental Outcome

Interventions

ironDIETARY_SUPPLEMENT

High, intermediate and low iron dosage orally for 2 months

Eligibility

Sex: ALLMax age: 32 Weeks

Medical Language ↔ Plain English

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

Locations (1)

University of Rochester Medical Center

Rochester, New York, United States

Outcomes

Primary Outcomes

mean interpeak latency Auditory Neural Myelination

This will be measured using auditory brain stem response.

Time frame: 43-45 weeks PMA

mean visual neural myelination

Visual myelination will be evaluated by visual evoked response.

Time frame: 43-45 weeks PMA

Secondary Outcomes

number of participants with executed function

Using a standardize test.

Time frame: 3-5 years

Data from ClinicalTrials.gov

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