Study title: A randomized double-blind study evaluating the safety, tolerability and efficacy of SMOF 20% compared to Intralipid in premature infants
Type of medicine: Herbal and homoeopathic medicines | |||||
Therapeutic area: Nutritional and Metabolic Diseases [C18] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: REFINED SOYBEAN OIL; MEDIUM CHAINED TRIGLYCERIDES; REFINED OLIVE OIL; FISH OIL | |||||
ATC code: B05B A02 | |||||
Document link: | |||||
Document date: | |||||
Study number: 00-SMOF-004 | |||||
EudraCT number: | |||||
Scope of study: CLINICAL | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
Y | Y | - | - | - |