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Vitamin Supplement

Folic Acid for Anemia of Prematurity (FASCINATE Trial)

N/A
Waitlist Available
Led By Belal Alshaikh, MD, MSc
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Postnatal age 14 days
Infants born at <29 weeks of gestational age admitted to Foothill Medical Centre
Must not have
Infants with ongoing pulmonary or gastroenterology hemorrhage by 14 days of life
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 34-36 weeks corrected gestational age
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at whether giving premature babies extra folic acid can help improve their blood levels and reduce the need for blood transfusions. Anemia is common in premature babies and it is thought that

Who is the study for?
This trial is for extremely preterm infants who are at risk of developing anemia, a condition where there's not enough healthy red blood cells. The study aims to include those who might benefit from extra folic acid, which is crucial for growth and DNA synthesis.
What is being tested?
The FACINATE trial tests if giving additional folic acid to these infants can improve their hemoglobin levels (which carry oxygen in the blood) and reduce the need for late-stage blood transfusions.
What are the potential side effects?
While side effects are not detailed here, typical reactions to folic acid could include gastrointestinal issues or allergic reactions. However, due to the age of patients, close monitoring will be essential.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My baby is at least 14 days old.
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My baby was born before 29 weeks and is admitted to Foothill Medical Centre.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My infant has had lung or stomach bleeding within the first 14 days of life.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 34-36 weeks corrected gestational age
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 34-36 weeks corrected gestational age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hemoglobin level
Secondary study objectives
Red blood cell transfusion

Side effects data

From 2016 Phase 3 trial • 243 Patients • NCT02293902
33%
Nasopharyngitis
12%
Neutropenia
10%
Injection site erythema
10%
Upper respiratory tract infection
10%
Hepatic function abnormal
9%
Eczema
9%
Alanine aminotransferase increased
7%
Stomatitis
6%
Injection site pruritus
6%
Cystitis
5%
Periodontitis
5%
White blood cell count decreased
5%
Bronchitis
5%
Pharyngitis
5%
Hypertension
2%
Neutrophil count decreased
2%
Back pain
2%
Leukopenia
2%
Dental caries
2%
Diarrhoea
2%
Gastroenteritis
2%
Gingivitis
2%
Contusion
2%
Rheumatoid arthritis
2%
Ingrowing nail
1%
Herpes zoster
1%
Infective myositis
1%
Pneumocystis jirovecii pneumonia
1%
Sepsis
1%
Pharyngeal abscess
1%
Oral candidiasis
1%
Lumbar spinal stenosis
1%
Chronic gastritis
1%
Foot deformity
1%
Influenza
1%
Scoliosis
1%
Generalised erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sarilumab 150 mg/150 mg
Sarilumab 200 mg/200 mg
Placebo/Sarilumab 150 mg
Placebo/Sarilumab 200 mg
Sarilumab Rescue

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental groupExperimental Treatment1 Intervention
Oral folic acid 50 mcg daily starts at 14 days of age
Group II: ControlActive Control1 Intervention
No additional folic acid supplementation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Folic acid
2008
Completed Phase 4
~8330

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
809 Previous Clinical Trials
886,293 Total Patients Enrolled
18 Trials studying Premature Birth
14,636 Patients Enrolled for Premature Birth
Belal Alshaikh, MD, MScPrincipal InvestigatorUniversity of Calgary
3 Previous Clinical Trials
470 Total Patients Enrolled
~60 spots leftby Jul 2027
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