Randomized Trial of Iron Supplementation to Prevent Anemia in Very-low-birth-weight Infants

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Kathleen Kennedy, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT01224236

First received: October 14, 2010

Last updated: February 23, 2012

Last verified: February 2012

History of Changes

Purpose

The purpose of this study is to determine if iron supplementation in addition to routine iron intake decreases the risk of developing anemia in preterm infants.

Condition	Intervention	Phase
Anemia	Drug: Iron Supplement Drug: control	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: Treatment
Official Title:	Randomized Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight (VLBW) Infants

Resource links provided by NLM:

MedlinePlus related topics: Anemia Birth Weight Iron

Drug Information available for: Ferrous sulfate Ferrous sulfate heptahydrate

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

Plasma hematocrit at 36 weeks postmenstrual age [ Time Frame: 36 weeks postmenstrual age ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	July 2010
Study Completion Date:	February 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: iron supplementation 2 mg/kg/day of elemental iron as a multivitamin with iron solution	Drug: Iron Supplement 2 mg/kg/day elemental iron as multivitamin with iron solution
Sham Comparator: control multivitamin solution without iron	Drug: control multivitamin solution without iron

Eligibility

Ages Eligible for Study:	up to 8 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

birth weight: < 1500 grams
Tolerating iron fortified preterm formula or fortified breast milk at 120cc/kg/day by 8 weeks of age
≤32 weeks adjusted post-menstrual age at the time of enrollment

Exclusion Criteria:

cyanotic heart disease
bowel resection prior to enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224236

Locations

United States, Texas
Children's Memorial Hermann Hospital
Houston, Texas, United States

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

Principal Investigator:

Kennedy Kathleen, MD

The University of Texas Health Science Center, Houston

More Information

No publications provided

Responsible Party:	Kathleen Kennedy, Professor - Pediatrics, Neonatology, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT01224236 History of Changes
Other Study ID Numbers:	RCT of Iron Supplementation
Study First Received:	October 14, 2010
Last Updated:	February 23, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anemia
Birth Weight
Hematologic Diseases
Body Weight
Signs and Symptoms
Iron

Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013

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