ClinicalTrials.gov
ClinicalTrials.gov Menu

Iron Status and Myelination in Premature Infants (Piron)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00684697
Recruitment Status : Active, not recruiting
First Posted : May 28, 2008
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Sanjiv Amin, 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.

Condition or disease Intervention/treatment Phase
Neurodevelopmental Outcome Dietary Supplement: iron Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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
Study Start Date : May 2008
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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




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

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


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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Sanjiv B Amin, MD MS University of Rochester

Responsible Party: Sanjiv Amin, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00684697     History of Changes
Other Study ID Numbers: Piron Trial
First Posted: May 28, 2008    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

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