Personalized versus standard intravenous nutrition for small premature infants
Phase 1
- Conditions
- Growth of preterm infants with a birth weight greater than 1250g on parenteral nutrition.Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2018-004946-41-ES
- Lead Sponsor
- Dr. Virgilio P. Carnielli,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
- Gestational age at birth < 37 weeks (or no more than 258 days);
- Birth weight > 1250 grams
- need of parenteral nutrition
- informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
• high probability of death in the 7 days following the start of NP
• genetic, metabolic or endocrine disorders diagnosed before inclusion
• Withdrawal of consent for study by parents or legal representative.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method