Iron Status and Myelination in Premature Infants

Not Applicable

Completed

• Conditions: Neurodevelopmental Outcome
• Interventions: Dietary Supplement: iron

• 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

Study Timeline

• Study First Submitted: 2008-05-22
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Study Start: 2009-05
• Primary Completion: 2015-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-02

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

Arm && Interventions

Group	Intervention	Description
3	iron	High Iron dose
2	iron	intermediate iron dose
1	iron	low iron dose

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