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

Preterm Neonates Clinical Trial

— SMOF  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02853253
• Other study ID #: 69HCL16_0135
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: May 2019

Study information

• Verified date: July 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Day

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Premature Birth
• Preterm Neonates

Intervention

Dietary Supplement:
• SMOFlipid®
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®
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.

Locations

Country	Name	City	State
France	Hopital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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