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

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ClinicalTrials.gov Identifier: NCT01224236
Recruitment Status : Completed
First Posted : October 19, 2010
Results First Posted : June 19, 2015
Last Update Posted : June 19, 2015
Sponsor:
Information provided by (Responsible Party):
Kathleen Kennedy, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Anemia Drug: Iron Supplement Drug: control Phase 2 Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight (VLBW) Infants
Study Start Date : July 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Hematocrit (Hct) [ Time Frame: 36 weeks postmenstrual age (PMA) ]
    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 :
  1. Transfusions [ Time Frame: enrollment to 36 weeks postmenstrual age (PMA) ]
    # of transfusions infants required after enrollment.



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Ages Eligible for Study:   up to 8 Weeks   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
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
First Posted: October 19, 2010    Key Record Dates
Results First Posted: June 19, 2015
Last Update Posted: June 19, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Anemia
Birth Weight
Hematologic Diseases
Body Weight
Signs and Symptoms
Pharmaceutical Solutions
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs