Iron Status and Myelination in Premature Infants

NCT ID: NCT00684697

Last Updated: 2021-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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Conditions

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Neurodevelopmental Outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

low iron dose

Group Type PLACEBO_COMPARATOR

iron

Intervention Type DIETARY_SUPPLEMENT

High, intermediate and low iron dosage orally for 2 months

2

intermediate iron dose

Group Type ACTIVE_COMPARATOR

iron

Intervention Type DIETARY_SUPPLEMENT

High, intermediate and low iron dosage orally for 2 months

3

High Iron dose

Group Type EXPERIMENTAL

iron

Intervention Type DIETARY_SUPPLEMENT

High, intermediate and low iron dosage orally for 2 months

Interventions

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iron

High, intermediate and low iron dosage orally for 2 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanjiv B Amin, MD MS

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Piron Trial

Identifier Type: -

Identifier Source: org_study_id

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