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Folic Acid Supplementation to Reduce Anemia in Extremely Preterm Infants

NCT06220461 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-05-09

No results posted yet for this 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.

Conditions

  • Extreme Prematurity
  • Anemia of Prematurity

Interventions

DIETARY_SUPPLEMENT

Folic acid

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

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Belal Alshaikh, MD, MSc · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2027-07-31
Completion
2028-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06220461 on ClinicalTrials.gov