Preterm Neonates
Conditions
Keywords
Preterm neonates
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.
Interventions
DIETARY_SUPPLEMENTSMOFlipid®
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.
DIETARY_SUPPLEMENTMedialipide®
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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Hours to 1 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Weight gain | at day 28 | 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 | at day 28 | Length growth velocity in cm/week at day 28 according to the following formulae: (length on day 28 - length at birth) / number of weeks |
| Head circumference growth velocity | at day 28 | Head circumference growth velocity in cm/week according to the following formulae: (head circumference on day 28 - head circumference at birth) / number of weeks |
Countries
France
Outcome results
None listed