SMOFlipid and Incidence of BPD in Preterm Infants

NCT04078906 | Unknown DMC

• 1 other identifier: REB19-1088
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

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

Keywords

Intravenous lipid emulsions; SMOF; Preterm Infants

Outcome Measures

Primary Outcomes (5)

• The incidence of Bronchopulmonary Disease

  According to Child Health and Human Development with classification to mild, moderate and severe.

  36 weeks corrected gestational age

• Fatty acid profile

  Determine serum fatty acids levels (μmol/L).

  First 3 weeks of life

• Pro-inflammatory cytokine response

  Compare pro-inflammatory cytokine levels (pg/mL)

  First 3 weeks of life

• Lipid peroxidation measure 1

  Malondialdehyde (MDA, μmol/L) in blood

  First 3 weeks of life

• Lipid peroxidation measure 2

  8-isoprostane levels (pg/mL) in blood

  First 3 weeks of life

Secondary Outcomes (5)

• Incidence of Cholestasis

  Up to 36 weeks corrected gestational age or discharge

• Weight gain velocity

  Up to 36 weeks corrected gestational age or discharge

• Incidence of retinopathy of prematurity

  Up to 36 weeks corrected gestational age or discharge

• Incidence of moderate to severe neurodevelopmental disability

  18-22 months corrected gestational

• Incidence of severe intraventricular hemorrhage (IVH)

  Up to 36 weeks corrected gestational age or discharge

Study Arms (2)

Control group

NO INTERVENTION

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

Experimental group

EXPERIMENTAL

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

Other: n3-LCPUFA enriched Intravenous Lipid Emulsion

Interventions

n3-LCPUFA enriched Intravenous Lipid Emulsion OTHER

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

Also known as: SMOFlipid

Experimental group

Eligibility Criteria

• Age: 1 Hour - 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

SMOFlipid

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Belal Alshaikh, MD, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Belal Alshaikh, MD, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Pediatrics

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: September 6, 2019
• Study Start: December 16, 2019
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)