Iron Status and Myelination in Premature Infants (Piron)

March 1, 2021 updated by: University of Rochester

Double Blind Randomized Placebo Controlled Trial of Iron Supplementation in Premature Infants

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
low iron dose
Dietary supplement: iron
High, intermediate and low iron dosage orally for 2 months
Active Comparator: 2
intermediate iron dose
Dietary supplement: iron
High, intermediate and low iron dosage orally for 2 months
Experimental: 3
High Iron dose
Dietary supplement: iron
High, intermediate and low iron dosage orally for 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean interpeak latency Auditory Neural Myelination
Time Frame: 43-45 weeks PMA
This will be measured using auditory brain stem response.
43-45 weeks PMA
mean visual neural myelination
Time Frame: 43-45 weeks PMA
Visual myelination will be evaluated by visual evoked response.
43-45 weeks PMA

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of participants with executed function
Time Frame: 3-5 years
Using a standardize test.
3-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Investigators

  • Principal Investigator: Sanjiv B Amin, MD MS, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2009

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

May 22, 2008

First Submitted That Met QC Criteria

May 27, 2008

First Posted (Estimate)

May 28, 2008

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Piron Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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