n3-LCPUFA enriched Intravenous Lipid Emulsion for Bronchopulmonary Dysplasia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Foothills Medical Centre, Calgary, CanadaBronchopulmonary Dysplasia+1 Moren3-LCPUFA enriched Intravenous Lipid Emulsion - Other
Eligibility
1 - 48
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Bronchopulmonary Dysplasia
  • Very Low Birthweight

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 5 Secondary · Reporting Duration: 18-22 months corrected gestational

18-22 months corrected gestational
Incidence of moderate to severe neurodevelopmental disability
Week 36
The incidence of Bronchopulmonary Disease
Week 3
Fatty acid profile
Lipid peroxidation measure
Lipid peroxidation measure 1
Lipid peroxidation measure 2
Pro-inflammatory cytokine response
Week 36
Incidence of Cholestasis
Incidence of retinopathy of prematurity
Incidence of severe intraventricular hemorrhage (IVH)
Weight gain velocity

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control group
1 of 2
Experimental group
1 of 2

Active Control

Experimental Treatment

384 Total Participants · 2 Treatment Groups

Primary Treatment: n3-LCPUFA enriched Intravenous Lipid Emulsion · No Placebo Group · N/A

Experimental group
Other
Experimental Group · 1 Intervention: n3-LCPUFA enriched Intravenous Lipid Emulsion · Intervention Types: Other
Control groupNoIntervention Group · 1 Intervention: Control group · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 18-22 months corrected gestational

Who is running the clinical trial?

University of CalgaryLead Sponsor
721 Previous Clinical Trials
574,175 Total Patients Enrolled
Belal Alshaikh, MD, MScPrincipal InvestigatorUniversity of Calgary
2 Previous Clinical Trials
86 Total Patients Enrolled

Eligibility Criteria

Age 1 - 48 · All Participants · 2 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.