Folic Acid Supplementation to Reduce Anemia in Extremely Preterm Infants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Calgary
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Infants with major congenital or chromosomal anomalies
Infants with ongoing pulmonary or gastroenterology hemorrhage by 14 days of life.
Trial design
Design model
Parallel
Treatments tested in this trial
Folic acid
Dietary supplementInfants allocated to the intervention group will receive folic acid (50 mcg flat dose/day) starting at 14 days of age.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Hemoglobin level
The difference in hemoglobin levels between the two groups
Time frame
At 34-36 weeks corrected gestational ageSecondary outcomes
1
Red blood cell transfusion
Number of required red blood cell transfusions
Time frame
After 14 days of age and until 36 weeks corrected gestational ageSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: