Folic Acid Supplementation to Reduce Anemia in Extremely Preterm Infants

NCT06220461 | Not Yet Recruiting

• 1 other identifier: REB23-1665
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

extreme preterm; folic acid deficiency; anemia of prematurity; neonatal blood transfusion

Outcome Measures

Primary Outcomes (1)

• Hemoglobin level

  The difference in hemoglobin levels between the two groups

  At 34-36 weeks corrected gestational age

Secondary Outcomes (1)

• Red blood cell transfusion

  After 14 days of age and until 36 weeks corrected gestational age

Study Arms (2)

Experimental group

EXPERIMENTAL

Oral folic acid 50 mcg daily starts at 14 days of age

Dietary Supplement: Folic acid

Control

NO INTERVENTION

No additional folic acid supplementation

Interventions

Folic acid DIETARY_SUPPLEMENT

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

Experimental group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Infants with major congenital or chromosomal anomalies
• Infants with ongoing pulmonary or gastroenterology hemorrhage by 14 days of life.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

Location

MeSH Terms

Conditions

Anemia; Folic Acid Deficiency

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Belal Alshaikh, MD, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Belal Alshaikh, MD, MSc

CONTACT

(403) 956 1588; belal.alshaikh@ahs.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 24, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 9, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)