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

NCT01224236 | Completed Phase 2 Results

• 1 other identifier: RCT of Iron Supplementation
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Hematocrit (Hct)

  For infants discharged from the hospital before 36 weeks' postmenstrual age (PMA), the last Hct before discharge was used. For infants transferred before 36 weeks PMA, the Hct at 36 weeks was sought from the receiving hospital and used if available. For infants transferred before 36 weeks with no available Hct at 36 weeks, the last Hct before transfer was used. For those who died before 36 weeks PMA, the Hct at 36 weeks was considered to be missing.

  36 weeks postmenstrual age (PMA)

Secondary Outcomes (1)

• Transfusions

  enrollment to 36 weeks postmenstrual age (PMA)

Study Arms (2)

iron supplementation

EXPERIMENTAL

2 mg/kg/day of elemental iron as a multivitamin with iron solution

Drug: Iron Supplement

control

SHAM COMPARATOR

multivitamin solution without iron

Drug: control

Interventions

Iron Supplement DRUG

2 mg/kg/day elemental iron as multivitamin with iron solution

iron supplementation

control DRUG

multivitamin solution without iron

control

Eligibility Criteria

• Age: Up to 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• cyanotic heart disease
• bowel resection prior to enrollment

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Taylor TA, Kennedy KA. Randomized trial of iron supplementation versus routine iron intake in VLBW infants. Pediatrics. 2013 Feb;131(2):e433-8. doi: 10.1542/peds.2012-1822. Epub 2013 Jan 21.

  PMID: 23339225 RESULT

MeSH Terms

Conditions

Anemia

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Kathleen Kennedy
• Organization: University of Texas Health Science Center - Houston

Kathleen.A.Kennedy@uth.tmc.edu

+1 (713) 500-5651

Study Officials

• Kennedy Kathleen, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Pediatrics, Neonatology

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 19, 2010
• Study Start: July 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: June 19, 2015
• Results First Posted: June 19, 2015

Record last verified: 2015-06

Locations

US (1)