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n3-LCPUFA enriched Intravenous Lipid Emulsion

Omega-3 Fatty Acid Infusion for Bronchopulmonary Dysplasia

N/A
Recruiting
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
Preterm infants born <30 weeks and admitted to NICU at Foothills Medical Centre in the first 24 hours of life.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18-22 months corrected gestational
Awards & highlights

Study Summary

This trial will compare two types of fat emulsions given to preterm infants to see if one type can lower the rate of bronchopulmonary dysplasia, a chronic lung condition.

Who is the study for?
This trial is for preterm infants born before 30 weeks, admitted to NICU at Foothills Medical Centre within their first day of life, and expected to need parenteral nutrition for over a week. It's not suitable for babies with perinatal asphyxia, congenital infections or anomalies, biliary atresia, or those suspected of metabolic disorders.Check my eligibility
What is being tested?
The study is testing if SMOFlipid, an intravenous lipid emulsion enriched with omega-3 fatty acids (n3-LCPUFA), can reduce the incidence of bronchopulmonary dysplasia (BPD) in very low birthweight preterm infants compared to the standard soybean-based Intralipid.See study design
What are the potential side effects?
Potential side effects may include reactions related to infusion such as infection risk due to compromised skin barrier or allergic responses. There might also be impacts on liver function which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby was born before 30 weeks and was in the NICU at Foothills Medical Centre within 24 hours of birth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18-22 months corrected gestational
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18-22 months corrected gestational for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fatty acid profile
Lipid peroxidation measure 1
Lipid peroxidation measure 2
+2 more
Secondary outcome measures
Incidence of Cholestasis
Incidence of moderate to severe neurodevelopmental disability
Incidence of retinopathy of prematurity
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental groupExperimental Treatment1 Intervention
n3-LCPUFA enriched IVLE (SMOFlipid) from D0 at 1g/kg/day and increase by 1 g/kg daily till reaching 3 g/kg/day.
Group II: Control groupActive Control1 Intervention
Conventional IVLE (Intralipid) from D0 at 1g/kg/day and increase by 1 g/kg daily till reaching 3 g/kg/day.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
792 Previous Clinical Trials
868,770 Total Patients Enrolled
Belal Alshaikh, MD, MScPrincipal InvestigatorUniversity of Calgary
3 Previous Clinical Trials
176 Total Patients Enrolled

Media Library

SMOFlipid (n3-LCPUFA enriched Intravenous Lipid Emulsion) Clinical Trial Eligibility Overview. Trial Name: NCT04078906 — N/A
Bronchopulmonary Dysplasia Research Study Groups: Experimental group, Control group
Bronchopulmonary Dysplasia Clinical Trial 2023: SMOFlipid Highlights & Side Effects. Trial Name: NCT04078906 — N/A
SMOFlipid (n3-LCPUFA enriched Intravenous Lipid Emulsion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04078906 — N/A

Frequently Asked Questions

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

Does my medical history make me a viable candidate to join this clinical study?

"In order to be accepted into this medical trial, prospective participants must have bronchopulmonary dysplasia and fall within the 1 Hour - 48 Hours age range. With 384 spots available in total, recruitment has already begun."

Answered by AI

Is registration for this investigation accessible to participants?

"Affirmative. Clinicaltrials.gov indicates that this medical trial is currently recruiting and was first posted on December 16th 2019. The most recent update was made November 4th 2022, with a target of 384 participants to be recruited from one site."

Answered by AI

What goals are researchers hoping to fulfill in this clinical trial?

"This clinical trial is testing lipid peroxidation over a three week period. Secondary outcomes include the incidence of severe intraventricular hemorrhage (IVH), weight gain velocity, and incidences of moderate to severe neurodevelopmental disability which includes motor impairment cerebral palsy (CP) or non-CP with a GMFCS level ≥2, BSID III cognitive scores below 70, bilateral blindness with vision <20/200, or permanent hearing loss that interferes with communication even when amplified."

Answered by AI

Is this experiment inviting participants of advanced age?

"According to the inclusion criteria, infants and toddlers from 1 hour old up to 48 hours can participate in this trial. 85 studies are available for children under 18 years of age, while 19 studies can be accessed by those aged 65 or above."

Answered by AI

How many individuals are currently being treated in this clinical research?

"Affirmative. Per the clinicaltrials.gov website, this research undertaking is presently in its recruitment phase since December 16th 2019 and was last updated on November 4th 2022. Aiming to sign up 384 individuals, it will take place at a single location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
SMOFlipid and Incidence of BPD in Preterm Infants
Belal Alshaikh 2019. "SMOFlipid and Incidence of BPD in Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04078906.
~34 spots leftby Oct 2024
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