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SMOFlipid and Incidence of BPD in Preterm Infants

NCT04078906 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2022-11-07

No results posted yet for this study

Summary

Despite many advances in neonatal care in the recent years, bronchopulmonary dysplasia (BPD) continues to be the major cause of chronic lung morbidity in infants. The pathogenesis of BPD is multifactorial; however, inflammation remains the central pathway for all risk factors. Omega-3 long chain polyunsaturated fatty acids (n3-LCPUFAs) from fish oil are known to down-regulate systemic inflammation and oxidative stress. Currently used soybean-based fatty acid emulsion (Intralipid) contains mainly n6-LCPUFA. Intralipid does not maintain the in-utero balanced LCPUFA accretion. Furthermore, Intralipid has been shown to increase free radical production and to be associated with BPD. A new fatty acid emulsion enriched with n3-LCPUFA (SMOFlipid) improves the fatty acid profile and reduces pro-inflammatory agents.

This project aims primarily to study whether SMOFlipid can lower the rate of BPD in preterm infants compared to Intralipid.

Conditions

  • Very Low Birth Weight Infant
  • Bronchopulmonary Dysplasia

Interventions

OTHER

n3-LCPUFA enriched Intravenous Lipid Emulsion

To start from D0 at 1g/kg/day and increase by 1 g/kg daily till reaching 3 g/kg/day.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Belal Alshaikh, MD, MSc · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04078906 on ClinicalTrials.gov