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

Primary Purpose

Anemia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Iron Supplement

control

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

undefined - 8 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children's Memorial Hermann Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

iron supplementation

control

Arm Description

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

multivitamin solution without iron

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Transfusions

# of transfusions infants required after enrollment.

Full Information

NCT ID

NCT01224236

First Posted

October 14, 2010

Last Updated

June 17, 2015

Sponsor

The University of Texas Health Science Center, Houston

1. Study Identification

Unique Protocol Identification Number

NCT01224236

Brief Title

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

Official Title

Randomized Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight (VLBW) Infants

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

iron supplementation

Arm Type

Experimental

Arm Description

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

Arm Title

control

Arm Type

Sham Comparator

Arm Description

multivitamin solution without iron

Intervention Type

Drug

Intervention Name(s)

Iron Supplement

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

control

Intervention Description

multivitamin solution without iron

Primary Outcome Measure Information:

Title

Hematocrit (Hct)

Description

Time Frame

36 weeks postmenstrual age (PMA)

Secondary Outcome Measure Information:

Title

Transfusions

Description

# of transfusions infants required after enrollment.

Time Frame

enrollment to 36 weeks postmenstrual age (PMA)

10. Eligibility

Sex

All

Maximum Age & Unit of Time

8 Weeks

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kennedy Kathleen, MD

Organizational Affiliation

The University of Texas Health Science Center, Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Memorial Hermann Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23339225

Citation

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.

Results Reference

result

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

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