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Iron Status and Myelination in Premature Infants (Piron)

This study is currently recruiting participants.
Verified August 2017 by Sanjiv Amin, University of Rochester
Sponsor:
ClinicalTrials.gov Identifier:
NCT00684697
First Posted: May 28, 2008
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanjiv Amin, University of Rochester
  Purpose
Premature infants with iron deficiency if supplemented with more elemental iron than the routine 2mg/kg/day will have improved brain development.

Condition Intervention Phase
Neurodevelopmental Outcome Dietary Supplement: iron Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Double Blind Randomized Placebo Controlled Trial of Iron Supplementation in Premature Infants

Resource links provided by NLM:


Further study details as provided by Sanjiv Amin, University of Rochester:

Primary Outcome Measures:
  • mean interpeak latency Auditory Neural Myelination [ Time Frame: 43-45 weeks PMA ]
    This will be measured using auditory brain stem response.

  • mean visual neural myelination [ Time Frame: 43-45 weeks PMA ]
    Visual myelination will be evaluated by visual evoked response.


Secondary Outcome Measures:
  • number of participants with executed function [ Time Frame: 3-5 years ]
    Using a standardize test.


Estimated Enrollment: 100
Study Start Date: May 2008
Estimated Study Completion Date: May 31, 2020
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684697


Contacts
Contact: Sanjiv B Amin, MD MS 585-273-2696 sanjiv_amin@urmc.rochester.edu

Locations
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Sanjiv B Amin, MD MS    585-273-2696    sanjiv_amin@urmc.rochester.edu   
Sub-Investigator: Mark Orlando, MS         
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Sanjiv B Amin, MD MS University of Rochester
  More Information

Responsible Party: Sanjiv Amin, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00684697     History of Changes
Other Study ID Numbers: Piron Trial
First Submitted: May 22, 2008
First Posted: May 28, 2008
Last Update Posted: August 17, 2017
Last Verified: August 2017

Keywords provided by Sanjiv Amin, University of Rochester:
premature infants iron neurodevelopment

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs