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

Phase 4

Withdrawn

• Conditions: Preterm Neonates
• Interventions: Dietary Supplement: Medialipide®; Dietary Supplement: SMOFlipid®

• Registration Number: NCT02853253
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-29
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-02
• Study Start: 2017-01
• Primary Completion: 2019-05
• Study Completion: 2019-05
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medialipide®	Medialipide®	parenteral nutrition using Medialipide® 20% (B Braun Medical, Boulogne, France)
SMOF	SMOFlipid®	parenteral nutrition using SMOFlipid® (FreseniusKabi France, Sèvres, France)

Primary Outcome Measures

Name	Time	Method
Rate of other free radical diseases	36 weeks corrected age	Free radical diseases include: intraventricular hemorrhage (IVH) \> grade II, retinopathy of prematurity (ROP) \> grade II, and necrotizing enterocolitis (NEC) \> grade IA (Bell classification).

Secondary Outcome Measures

Name	Time	Method
Weight gain	week 36 corrected age	Weight gain in g/kg/j according to the following formulae: 1000 \* ((weight on day 28 or week 36 - birth weight)/((weight on day 28 or week 36 + birth weight)/2)) / number of days
Growth velocity	week 36 corrected age	Length growth velocity in cm/week at week 36 corrected age according to the following formulae: (length on week 36 - length at birth) / number of weeks
Head circumference growth velocity	at week 36 corrected age	Head circumference growth velocity in cm/week according to the following formulae: (head circumference on week 36 - head circumference at birth) / number of weeks

Trial Locations

Locations (1)

Hopital Femme Mère Enfant; 🇫🇷 Bron, France