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Lipidic emulsions influence on immune response of pre-term VLBW newborns treated with total parenteral nutrition - ND

Lipidic emulsions influence on immune response of pre-term VLBW newborns treated with total parenteral nutrition - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-007550-66-IT
Enrollment
Unknown
Registered
2008-04-10
Start date
2008-02-21
Completion date
Unknown
Last updated
2014-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

very low birth weight newborn MedDRA version: 9.1 Level: LLT Classification code 10036590 Term: Premature baby

Interventions

Trade Name: LIPOFUNDIN MCT*FL 100ML 10% Pharmaceutical Form: Emulsion for infusion INN or Proposed INN: TRIGLICERIDI A CATENA MEDIA/OLIO DI SOIA PER USO PARENTERALE/LECITINA D'UOVO/GLICEROLO CAS Numb

Sponsors

OSPEDALE POLICLINICO S. MATTEO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: pre-term newborns (gestational age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: congenital immunodeficiency, need of therapies that interfere with immune response (i.e. corticosteroids), need of trasfusion, ...

Design outcomes

Primary

MeasureTime frame
Main Objective: to evaluate IS cellular response in pre-term newborns with weight < 1750 g and gestational age </= 32 weeks treated with total parenteral nutrition;Secondary Objective: safety evaluation;Primary end point(s): cellular IS response—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026