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Iron Status and Myelination in Premature Infants (Piron)

This study is currently recruiting participants.
Verified March 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: March 19, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

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: 80
Study Start Date: May 2008
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2013 (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 32 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
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
Contact: AYESHA KHAN, MPH 585-275-5427 ayesha_khan@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    
Contact: Ayesha Khan, MPH     585-275-5427     Ayesha_khan@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: March 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
premature infants iron neurodevelopment

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

ClinicalTrials.gov processed this record on June 18, 2013