- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01224236
Randomized Trial of Iron Supplementation to Prevent Anemia in Very-low-birth-weight Infants
Randomized Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight (VLBW) Infants
Study Overview
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
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Children's Memorial Hermann Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: iron supplementation
2 mg/kg/day of elemental iron as a multivitamin with iron solution
|
2 mg/kg/day elemental iron as multivitamin with iron solution
|
Sham Comparator: control
multivitamin solution without iron
|
multivitamin solution without iron
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
36 weeks postmenstrual age (PMA)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transfusions
Time Frame: enrollment to 36 weeks postmenstrual age (PMA)
|
# of transfusions infants required after enrollment.
|
enrollment to 36 weeks postmenstrual age (PMA)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kennedy Kathleen, MD, The University of Texas Health Science Center, Houston
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCT of Iron Supplementation
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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