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

Study Overview
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Brief Summary
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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.

Official Title
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Rate of Bronchopulmonary Dysplasia in Preterms Neonates Less Than 29 Weeks' Gestational Age and / or With Birth Weight Less Than 1000 g: a Double Blind Randomized Controlled Multicenter Trial Comparing SMOFlipid and Medialipide

Conditions
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Preterm Neonates

Intervention / Treatment
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* Dietary Supplement: SMOFlipid®
* Dietary Supplement: Medialipide®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Hours
Maximum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMOF<br>parenteral nutrition using SMOFlipid® (FreseniusKabi France, Sèvres, France) | Dietary Supplement: SMOFlipid®<br>* 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.<br>|
| Active Comparator: Medialipide®<br>parenteral nutrition using Medialipide® 20% (B Braun Medical, Boulogne, France) | Dietary Supplement: Medialipide®<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain | 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 | at day 28 | 
| Weight gain | 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 | week 36 corrected age | 
| Growth velocity | Length growth velocity in cm/week at day 28 according to the following formulae: (length on day 28 - length at birth) / number of weeks | at day 28 | 
| Growth velocity | 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 | week 36 corrected age | 
| Head circumference growth velocity | Head circumference growth velocity in cm/week according to the following formulae: (head circumference on day 28 - head circumference at birth) / number of weeks | at day 28 | 
| Head circumference growth velocity | Head circumference growth velocity in cm/week according to the following formulae: (head circumference on week 36 - head circumference at birth) / number of weeks | at week 36 corrected age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm neonates