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

NCT02853253 | Withdrawn Phase 4 DMC

• 1 other identifier: 69HCL16_0135
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Neonates

Keywords

Preterm neonates

Outcome Measures

Primary Outcomes (1)

• Rate of other free radical diseases

  Free radical diseases include: intraventricular hemorrhage (IVH) \> grade II, retinopathy of prematurity (ROP) \> grade II, and necrotizing enterocolitis (NEC) \> grade IA (Bell classification).

  36 weeks corrected age

Secondary Outcomes (6)

• Weight gain

  at day 28

• Weight gain

  week 36 corrected age

• Growth velocity

  at day 28

• Growth velocity

  week 36 corrected age

• Head circumference growth velocity

  at day 28

Study Arms (2)

SMOF

EXPERIMENTAL

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

Dietary Supplement: SMOFlipid®

Medialipide®

ACTIVE COMPARATOR

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

Dietary Supplement: Medialipide®

Interventions

SMOFlipid® DIETARY_SUPPLEMENT

SMOFlipid® (FreseniusKabi France, Sèvres, France). It is a 3rd generation LE containing a physical mixture of soybean oil (30%), MCT (30%), olive oil (25%) and fish oil (15%). Its ratio omega6/omega 3 is 2,5/1. SMOF will be initiated within the 1st day of life of neonates and will be prescribed daily by the attending physician following these guidelines: initiation rate: 1 g/kg/day; daily increase: 0.5 to 1 g/kg/day ; target: 3 to 4 g/kg/day. All included preterms will receive nutritional support according to a single protocol based on the ESPGHAN recommendations: parenteral glucose and amino acids (Primene 10%, Clintec Parenteral, Maurepas, France) soon after birth (in their 1st day of life). Initiation rate of parenteral glucose and amino acids will be 6 to 8 g/kg/day and 2 g/kg/day respectively. The daily increase of parenteral glucose and amino acids will be 1 to 2 g/kg/day and 0.5 g/kg/day respectively, for a target rate of 14 to 17 g/kg/day and 3.5 g/kg/day respectively.

SMOF

Medialipide® DIETARY_SUPPLEMENT

Medialipide® 20% (B Braun Medical, Boulogne, France). It is a second generation LE containing soybean oil (50%) and MCT (50%). Its ratio omega6/omega 3 is 7/4. Medialipide will be initiated within the 1st day of life of neonates and will be prescribed daily by the attending physician following these guidelines: initiation rate: 1 g/kg/day ; daily increase: 0.5 to 1 g/kg/day; target: 3 to 4 g/kg/day. All included preterms will receive nutritional support according to a single protocol based on the ESPGHAN recommendations: parenteral glucose and amino acids (Primene 10%, Clintec Parenteral, Maurepas, France) soon after birth (in their 1st day of life). Initiation rate of parenteral glucose and amino acids will be 6 to 8 g/kg/day and 2 g/kg/day respectively. The daily increase of parenteral glucose and amino acids will be 1 to 2 g/kg/day and 0.5 g/kg/day respectively, for a target rate of 14 to 17 g/kg/day and 3.5 g/kg/day respectively.

Medialipide®

Eligibility Criteria

• Age: 6 Hours - 1 Day
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopital Femme Mère Enfant

Bron, France

Location

MeSH Terms

Interventions

SMOFlipid

Study Officials

• Olivier CLARIS, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 2, 2016
• Study Start: January 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)