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: June 17, 2015
Last verified: June 2015
  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:


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

Primary Outcome Measures:
  • Hematocrit (Hct) [ Time Frame: 36 weeks postmenstrual age (PMA) ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Transfusions [ Time Frame: enrollment to 36 weeks postmenstrual age (PMA) ] [ Designated as safety issue: Yes ]
    # of transfusions infants required after enrollment.


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

Detailed Description:

Objective was to determine if iron supplementation of 2 mg/kg per day, in addition to routine iron-fortified formula or mother's milk, increased the hematocrit (Hct) at 36 weeks' postmenstrual age (PMA).

All infants have a decline in hemoglobin(Hgb) after birth because of increasing PaO2 and Hgb saturation after birth. In very low birth weight (VLBW) infants (birth weight ,1500 g), the nadir at 1 to 3 months after birth is lower than in term infants because of (1) greater phlebotomy losses for blood tests, (2) shortened red blood cell survival, and (3)rapid growth.

VLBW infants may be at increased risk of developing iron deficiency anemia because of (1) low iron stores at birth, (2) rapid depletion of iron stores owing to phlebotomy losses, and (3) inability to regulate iron absorption by the gastrointestinal tract.

  Eligibility

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

Inclusion Criteria:

  1. birth weight: < 1500 grams
  2. Tolerating iron fortified preterm formula or fortified breast milk at 120cc/kg/day by 8 weeks of age
  3. ≤32 weeks adjusted post-menstrual age at the time of enrollment

Exclusion Criteria:

  1. cyanotic heart disease
  2. bowel resection prior to enrollment
  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: NCT01224236

Locations
United States, Texas
Children's Memorial Hermann Hospital
Houston, Texas, United States, 77030
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

Publications:
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
Results First Received: July 3, 2013
Last Updated: June 17, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Iron
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on August 27, 2015