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Vitamin Supplement

Experimental group for Premature Birth (FASCINATE Trial)

Q: Are there any current openings for participants in this ongoing trial?

<p>According to the information provided on clinicaltrials.gov, this trial is not actively seeking participants. The study was initially posted on March 11th, 2024 and last updated on January 22nd, 2024. Although this specific clinical trial is no longer recruiting patients, it's worth noting that there are currently 500 other trials actively searching for eligible candidates.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 34-36 weeks corrected gestational age

Awards & highlights

FASCINATE Trial 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.Check my eligibility

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.See study design

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.

FASCINATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My baby is at least 14 days old.

Select...

My baby was born before 29 weeks and is admitted to Foothill Medical Centre.

FASCINATE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 34-36 weeks corrected gestational age

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hemoglobin level

Secondary outcome measures

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

Eczema

Alanine aminotransferase increased

Stomatitis

Injection site pruritus

Cystitis

Periodontitis

White blood cell count decreased

Bronchitis

Pharyngitis

Hypertension

Neutrophil count decreased

Back pain

Leukopenia

Dental caries

Diarrhoea

Gastroenteritis

Gingivitis

Contusion

Rheumatoid arthritis

Ingrowing nail

Herpes zoster

Infective myositis

Pneumocystis jirovecii pneumonia

Sepsis

Pharyngeal abscess

Oral candidiasis

Lumbar spinal stenosis

Chronic gastritis

Foot deformity

Influenza

Scoliosis

Generalised erythema

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Sarilumab 150 mg/150 mg

Sarilumab 200 mg/200 mg

Placebo/Sarilumab 150 mg

Placebo/Sarilumab 200 mg

Sarilumab Rescue

FASCINATE 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,064 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current openings for participants in this ongoing trial?

"According to the information provided on clinicaltrials.gov, this trial is not actively seeking participants. The study was initially posted on March 11th, 2024 and last updated on January 22nd, 2024. Although this specific clinical trial is no longer recruiting patients, it's worth noting that there are currently 500 other trials actively searching for eligible candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Folic Acid Supplementation to Reduce Anemia in Extremely Preterm Infants

2024. "Folic Acid Supplementation to Reduce Anemia in Extremely Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06220461.