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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
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.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
Hopital Femme Mère Enfant
Bron, France
Start Date
January 1, 2017
Primary Completion Date
May 1, 2019
Completion Date
May 1, 2019
Last Updated
July 24, 2019
SMOFlipid®
DIETARY_SUPPLEMENT
Medialipide®
DIETARY_SUPPLEMENT
Lead Sponsor
Hospices Civils de Lyon
NCT07274969
NCT06202911
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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