Recruiting

SMOFlipid

Sponsor:

University of Calgary

Code:

NCT04078906

Conditions

Very Low Birth Weight Infant

Bronchopulmonary Dysplasia

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

n3-LCPUFA enriched Intravenous Lipid Emulsion

Study Details

Brief 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

Study ID

NCT04078906

Start date

Dec 16, 2019

Status verified date

Nov, 2022

Completion date

Oct, 2024

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Preterm infants born <30 weeks and admitted to NICU at Foothills Medical Centre in the first 24 hours of life.
  • Anticipated duration of PN for >7 days

Exclusion Criteria:

  • Infants with congenital anomalies
  • Infants with suspected inborn errors of metabolism or family history of inborn error of metabolism
  • Perinatal asphyxia
  • Evidence of congenital infection
  • Primary biliary atresia

Study Design

Enrollment

384 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control group

Conventional IVLE (Intralipid) from D0 at 1g/kg/day and increase by 1 g/kg daily till reaching 3 g/kg/day.

experimental: Experimental group

n3-LCPUFA enriched IVLE (SMOFlipid) from D0 at 1g/kg/day and increase by 1 g/kg daily till reaching 3 g/kg/day.

Interventions

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.

Primary outcome measure

  • The incidence of Bronchopulmonary Disease [ Time Frame: 36 weeks corrected gestational age ]
  • Fatty acid profile [ Time Frame: First 3 weeks of life ]
  • Pro-inflammatory cytokine response [ Time Frame: First 3 weeks of life ]
  • Lipid peroxidation measure 1 [ Time Frame: First 3 weeks of life ]
  • Lipid peroxidation measure 2 [ Time Frame: First 3 weeks of life ]

Central Contacts and Locations

Central contacts

Belal Alshaikh, MD, MSc

(403) 956 1588belal.alshaikh@ahs.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

Belal Alshaikh, MD

belal.alshaikh@ahs.ca

More Information

Sponsor

University of Calgary

Last update posted

Nov 7, 2022

Last verified

Nov, 2022

Keywords

  • Intravenous lipid emulsions
  • SMOF
  • Preterm Infants

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2022-11-07.