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Iron Supplementation of Marginally Low Birth Weight Infants (JOHN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Umeå University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
Jerring Foundation, Sweden
Oskar Foundation
Information provided by (Responsible Party):
Magnus Domellöf, Umeå University
ClinicalTrials.gov Identifier:
NCT00558454
First received: November 14, 2007
Last updated: June 4, 2012
Last verified: June 2012

November 14, 2007
June 4, 2012
March 2004
June 2008   (final data collection date for primary outcome measure)
Neurological developement [ Time Frame: 6 months, 3 years and 7 years ] [ Designated as safety issue: Yes ]
6 mo: Auditory brain stem response (central conduction time) 3 y: CBCL - Parental questionnaire assessing behavioral problems and WIPPSI - test of cognitive functions 7 y: SDQ, 5-15 and CBCL - Parental questionnaires assessing behavioral problems, TeAch - test of behavioral problems and WISC - test of cognitive functions.
Auditory brain stem response (central conduction time) [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00558454 on ClinicalTrials.gov Archive Site
  • Growth (weight, length, head circumference, knee-heel length), Morbidity and Iron status (Hemoglobin, ferritin etc) [ Time Frame: 6 months ]
  • Growth, Iron status, and Morbidity [ Time Frame: 3 years and 7 years ] [ Designated as safety issue: Yes ]
  • Growth (weight, length, head circumference, knee-heel length), Morbidity and Iron status (Hemoglobin, ferritin etc) [ Time Frame: 6 months ]
  • Cognitive development (WPPSI-III) Growth Iron status [ Time Frame: 3 years ]
  • Cognitive development Growth Iron status [ Time Frame: 7 years ]
Not Provided
Not Provided
 
Iron Supplementation of Marginally Low Birth Weight Infants
Randomized, Controlled Study of Iron Supplementation of Infants With Birth Weights 2000-2500 g

Iron is essential for brain development and there is a well established association between iron deficiency in infants and poor neurological development. In Sweden, about 5% of newborns have low birth weight (< 2500 g). Due to small iron stores at birth and rapid postnatal growth, they have increased risk of iron deficiency and it is therefore important to prevent iron deficiency in this population. However, excessive iron supplementation can have adverse effects in infants such as growth impairment. In a randomized, controlled trial, we are investigating the effects of 0, 1 or 2 mg/kg/d of iron on brain myelination, cognitive development and growth in low birth weight infants.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Anemia
  • Iron-Deficiency
  • Child Behavior Disorders
  • Cognitive Manifestations
Drug: Iron
Ferrous succinate mixture
Other Name: Ferromyn S, AstraZeneca, Södertälje, Sweden
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: Iron
  • Experimental: 2
    1 mg/kg/day from age 6 weeks to 6 months
    Intervention: Drug: Iron
  • Experimental: 3
    2 mg/kg/day from age 6 weeks to 6 months
    Intervention: Drug: Iron

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
380
November 2014
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Marginally low birth weight (2000-2500 g)
  • Healthy at inclusion(6 weeks of age)
  • No previous blood transfusion
  • No previous iron supplementation

Exclusion Criteria:

  • Anemia at inclusion
Both
39 Days to 45 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00558454
Iron for LBW infants
Yes
Magnus Domellöf, Umeå University
Umeå University
  • The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
  • Jerring Foundation, Sweden
  • Oskar Foundation
Principal Investigator: Magnus Domellöf, MD, PhD Umeå University, Sweden
Umeå University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP