search
Back to results

Iron Status and Myelination in Premature Infants (Piron)

Primary Purpose

Neurodevelopmental Outcome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iron
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neurodevelopmental Outcome focused on measuring premature infants iron neurodevelopment

Eligibility Criteria

undefined - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

1

2

3

Arm Description

low iron dose

intermediate iron dose

High Iron dose

Outcomes

Primary Outcome Measures

mean interpeak latency Auditory Neural Myelination
This will be measured using auditory brain stem response.
mean visual neural myelination
Visual myelination will be evaluated by visual evoked response.

Secondary Outcome Measures

number of participants with executed function
Using a standardize test.

Full Information

First Posted
May 22, 2008
Last Updated
March 1, 2021
Sponsor
University of Rochester
search

1. Study Identification

Unique Protocol Identification Number
NCT00684697
Brief Title
Iron Status and Myelination in Premature Infants
Acronym
Piron
Official Title
Double Blind Randomized Placebo Controlled Trial of Iron Supplementation in Premature Infants
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 2009 (Actual)
Primary Completion Date
December 31, 2015 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Rochester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodevelopmental Outcome
Keywords
premature infants iron neurodevelopment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
low iron dose
Arm Title
2
Arm Type
Active Comparator
Arm Description
intermediate iron dose
Arm Title
3
Arm Type
Experimental
Arm Description
High Iron dose
Intervention Type
Dietary Supplement
Intervention Name(s)
iron
Intervention Description
High, intermediate and low iron dosage orally for 2 months
Primary Outcome Measure Information:
Title
mean interpeak latency Auditory Neural Myelination
Description
This will be measured using auditory brain stem response.
Time Frame
43-45 weeks PMA
Title
mean visual neural myelination
Description
Visual myelination will be evaluated by visual evoked response.
Time Frame
43-45 weeks PMA
Secondary Outcome Measure Information:
Title
number of participants with executed function
Description
Using a standardize test.
Time Frame
3-5 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjiv B Amin, MD MS
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Iron Status and Myelination in Premature Infants

We'll reach out to this number within 24 hrs