Rate of Bronchopulmonary Dysplasia in Preterms Neonates: a Trial Comparing SMOFlipid and Medialipide

Civil Hospices of Lyon

Status and phase: Withdrawn; Phase 4

Conditions: Preterm Neonates

Treatments: Dietary Supplement: SMOFlipid®; Dietary Supplement: Medialipide®

Study type: Interventional

Funder types: Other

Identifiers

NCT02853253

69HCL16_0135

Details and patient eligibility

About

SMOF is a large double blind placebo-controlled randomized clinical trial aiming to compare the rate of bronchopulmonary dysplasia (BPD) at 36 weeks corrected age in premature infants < 29 weeks and / or with birth weight < 1000 g receiving either SMOFlipid® or Medialipide® 20%. This study will offer new information for optimizing the management of preterms requiring parenteral nutrition. The investigators hypothesis is that the composition of SMOFlipid may decrease lipid peroxidation and oxidative stress in preterms, resulting in a lower incidence of BPD.

Sex: All

Ages: 6 hours to 1 day old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm neonates with gestational age < 29 weeks and / or birth weight < 1000 g
• Admission in the Intensive Care Unit within 6 h after birth
• IV Lipid Emulsion (LE) started latest at first day of life
• Anticipated duration of Parenteral Nutrition >10 days
• Informed consent from legal representative

Exclusion criteria

• Inherited metabolic diseases
• Major congenital malformations
• Participation to another study evaluating any kind of medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

SMOF

Experimental group

Description:

parenteral nutrition using SMOFlipid® (FreseniusKabi France, Sèvres, France)

Treatment:

Dietary Supplement: SMOFlipid®

Medialipide®

Active Comparator group

Description:

parenteral nutrition using Medialipide® 20% (B Braun Medical, Boulogne, France)

Treatment:

Dietary Supplement: Medialipide®