Folic Acid Supplementation to Reduce Anemia in Extremely Preterm Infants
NCT ID: NCT06220461
Last Updated: 2024-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2024-06-01
2028-07-31
Brief Summary
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Detailed Description
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To manage this anemia, most infants receive packed red blood cell transfusions, often based on specific hemoglobin thresholds. Despite efforts to minimize transfusion needs in ELBW infants, over 80% still require transfusions during their initial hospital stay. However, these transfusions come with potential adverse effects like infections, immune imbalances, lung and gut injuries, bronchopulmonary dysplasia, and retinopathy of prematurity.
Folic acid is crucial for fetal and postnatal development, playing a central role in DNA synthesis and supporting cell division. Its deficiency can hinder DNA synthesis, cause erythroblast apoptosis, and lead to anemia due to ineffective erythropoiesis. Preterm infants often lack sufficient folic acid, even more so in unfortified breast milk, which contains lower levels than recommended for adequate intake.
Supplementing folic acid for preterm infants began in the early 1990s based on limited studies on low-birth-weight (LBW) infants, primarily formula-fed and weighing \>1000 grams. Despite its widespread use, there's insufficient robust evidence specifying the ideal dosage or confirming its effectiveness in preventing AOP or improving hemoglobin levels.
Unfortified breast milk's folic acid content falls short of recommended levels, especially for ELBW infants due to limited hepatic stores and rapid growth. Fortified breast milk or preterm formulas provide varying amounts of folic acid but might still be insufficient, especially for infants on restricted fluid intake due to lung injury.
The FACINATE trial aims to investigate whether additional supplementation of 50 mcg/day of folic acid improves hemoglobin levels and reduces late (\>14 days of age) blood transfusions in extremely preterm infants, a specific question not yet explored in existing literature.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Experimental group
Oral folic acid 50 mcg daily starts at 14 days of age
Folic acid
Infants allocated to the intervention group will receive folic acid (50 mcg flat dose/day) starting at 14 days of age.
Control
No additional folic acid supplementation
No interventions assigned to this group
Interventions
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Folic acid
Infants allocated to the intervention group will receive folic acid (50 mcg flat dose/day) starting at 14 days of age.
Eligibility Criteria
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Inclusion Criteria
* Postnatal age 14 days.
* On minimum enteral feeding of 100 mL/kg/day
Exclusion Criteria
* Infants with ongoing pulmonary or gastroenterology hemorrhage by 14 days of life.
ALL
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Principal Investigators
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Belal Alshaikh, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Foothills Medical Centre
Calgary, Alberta, Canada
Countries
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Central Contacts
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Other Identifiers
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REB23-1665
Identifier Type: -
Identifier Source: org_study_id
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