A Phase 4 interventional study of SMOFlipid® and Medialipide® in Preterm Neonates, sponsored by Hospices Civils de Lyon. Withdrawn at 1 site in France. Open to participants aged 6 Hours to 1 Day. Per ClinicalTrials.gov, last updated 2019-07-24.
Sponsored by Hospices Civils de Lyon · Phase 4, Interventional, and Treatment
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.
Hospices Civils de Lyon is the lead sponsor of 1,856 studies on the registry; 442 are open to participants now.
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Exclusion Criteria:
parenteral nutrition using SMOFlipid® (FreseniusKabi France, Sèvres, France)
Dietary Supplement: SMOFlipid®
parenteral nutrition using Medialipide® 20% (B Braun Medical, Boulogne, France)
Dietary Supplement: Medialipide®
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.
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.
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).
Time frame: 36 weeks corrected age
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at week 36 corrected age
Plan to share: No
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The record gives a start of Jan 2017, a primary completion of May 2019 and a completion of May 2019. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SMOFlipid