Iron Status and Myelination in Premature Infants (Piron)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Rochester
Sponsor:
Information provided by (Responsible Party):
sanjiv amin, University of Rochester
ClinicalTrials.gov Identifier:
NCT00684697
First received: May 22, 2008
Last updated: November 1, 2013
Last verified: November 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 University of Rochester:

Primary Outcome Measures:
  • Auditory Neural Myelination [ Time Frame: 43-45 weeks PMA ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Neurodevelopmental outcome [ Time Frame: 6 - 9 months and 2 years corrected age ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2008
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: October 2014 (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

Ages Eligible for Study:   up to 32 Weeks
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: sanjiv amin, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00684697     History of Changes
Other Study ID Numbers: Piron Trial
Study First Received: May 22, 2008
Last Updated: November 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
premature infants iron neurodevelopment

Additional relevant MeSH terms:
Iron
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on October 23, 2014