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Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants

Primary Purpose

Iron Deficiency Anemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Iron Supplement
multivitamin
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Iron Deficiency Anemia focused on measuring very low birth weight infants, anemia, iron supplementation

Eligibility Criteria

24 Weeks - 32 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Birth weight <1500 grams
  • Tolerating iron fortified preterm formula or fortified human 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, Texas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

multivitamin with iron

multivitamin without iron

Arm Description

daily oral multivitamin providing 2mg/kg of iron

daily oral multivitamin without iron

Outcomes

Primary Outcome Measures

Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA)
For infants discharged home prior to 36 wks PMA, the last Hct was used.For infants transferred prior to 36 wks PMA, the Hct at receiving hospital was used if available. A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and those transfused could be included in an intention-to-treat analysis.Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wk PMA Hct was used as the primary outcome.

Secondary Outcome Measures

Number of Participants Who Received Red Cell Transfusions During Intervention Period
The numbers below represent the number of participants in each arm that received a transfusion during intervention period.

Full Information

First Posted
May 13, 2010
Last Updated
July 10, 2018
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT01125163
Brief Title
Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants
Official Title
Randomized Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In preterm infants with birth weights less than 1500 grams, does iron supplementation with 2mg/kg/day in addition to routine feeding with routine iron-fortified milk (formula or fortified mother's milk), as compared to routine iron fortified milk, increase hematocrit at 36 weeks adjusted postmenstrual age (or at discharge if sooner)?
Detailed Description
Fortified mother's milk or fortified formula is routine practice in neonatal units and is not an intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
very low birth weight infants, anemia, iron supplementation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
multivitamin with iron
Arm Type
Active Comparator
Arm Description
daily oral multivitamin providing 2mg/kg of iron
Arm Title
multivitamin without iron
Arm Type
Placebo Comparator
Arm Description
daily oral multivitamin without iron
Intervention Type
Dietary Supplement
Intervention Name(s)
Iron Supplement
Other Intervention Name(s)
iron supplementation
Intervention Description
multivitamin that provides 2mg/kg/day of iron given orally to infants when they are tolerating 120 ml/dg/day of preterm formula or fortified breast milk until they reach 36 weeks adjusted postmenstrual age.
Intervention Type
Dietary Supplement
Intervention Name(s)
multivitamin
Other Intervention Name(s)
Multivitamin without iron
Intervention Description
daily oral multivitamin without iron until 36 weeks adjusted postmenstrual age
Primary Outcome Measure Information:
Title
Hematocrit (Hct) at 36 Wks Post Menstrual Age (PMA)
Description
For infants discharged home prior to 36 wks PMA, the last Hct was used.For infants transferred prior to 36 wks PMA, the Hct at receiving hospital was used if available. A non-parametric rank sum analysis was performed as follows so that infants who died before 36 wks and those transfused could be included in an intention-to-treat analysis.Infants were ranked by death (lowest rank) then by number of transfusions (next lowest ranks). For infants who survived and were not transfused, the 36 wk PMA Hct was used as the primary outcome.
Time Frame
at 36 weeks adjusted postmenstrual age
Secondary Outcome Measure Information:
Title
Number of Participants Who Received Red Cell Transfusions During Intervention Period
Description
The numbers below represent the number of participants in each arm that received a transfusion during intervention period.
Time Frame
from study day 1 to 36 week adjusted postmenstrual age or discharge if the infant is discharged sooner

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Birth weight <1500 grams Tolerating iron fortified preterm formula or fortified human 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
Tiffany Taylor, M.D.
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Memorial Hermann Hospital, Texas Medical Center
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
derived

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Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants

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