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Clinical Trials in Canada / NCT06220461
Starting soon Not applicable

Folic Acid Supplementation to Reduce Anemia in Extremely Preterm Infants

NCT06220461 · tracked via the Priya Life Science Canada tracker
Sponsor
University of Calgary
Phase
Not applicable
Started
2024-06-01
Last updated
2024-05-09

Condition(s) studied

Extreme PrematurityAnemia of Prematurity

Investigational drug(s) / intervention(s)

Folic acid

Folic acid: Infants allocated to the intervention group will receive folic acid (50 mcg flat dose/day) starting at 14 days of age.

Study summary

Anemia of Prematurity (AOP) is very common in extremely preterm infants and often leads to blood transfusions. Folic acid, essential for growth and DNA synthesis, is deficient in premature infants. Despite the adoption of folic acid supplementation, evidence supporting its effectiveness in preventing AOP remains scarce. Recommendations for folic acid intake exceed what's naturally found in breast milk, particularly for extremely low birthweight infants. Practices regarding folic acid supplementation vary widely, prompting the need for research. The FACINATE trial aims to determine if additional folic acid supplementation improves hemoglobin levels and reduces late blood transfusions in extremely preterm infants, a question not addressed in current literature.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Infants born at \<29 weeks of gestational age admitted to Foothill Medical Centre. * Postnatal age 14 days. * On minimum enteral feeding of 100 mL/kg/day Exclusion Criteria: * Infants with major congenital or chromosomal anomalies * Infants with ongoing pulmonary or gastroenterology hemorrhage by 14 days of life.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Foothills Medical Centre Calgary Alberta

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06220461 on ClinicalTrials.gov ↗ ← All trials in Canada