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A comparison of the effects on prostaglandin synthesis and cytokine production of an olive-oil based lipid emulsion (Clinoloeic) with a soya based emulsion (Intralipid) in newborn infnats receiving parenteral nutrition. - Clinoleic cytokine study

A comparison of the effects on prostaglandin synthesis and cytokine production of an olive-oil based lipid emulsion (Clinoloeic) with a soya based emulsion (Intralipid) in newborn infnats receiving parenteral nutrition. - Clinoleic cytokine study

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-001653-28-GB
Enrollment
50
Registered
2005-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2017-10-02

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

Conditions

Prematurity Parenteral nutrition

Interventions

Trade Name: Clinoleic 20% Product Name: Clinoleic 20% Product Code: 3B6014R79 Pharmaceutical Form: Emulsion for infusion Pharmaceutical form of the placebo: Emulsion for infusion Route of administrati

Sponsors

The Leeds teaching Hospitals NHS trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Preterm =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: >=38 weeks gestational age severe hyperbilirubinaemia (>exchange transfusion level) infants with proven severe sepsis, in whom lipid emulsion would be contraindicated Infants with hypertriglyceridaemia / hyperlipidaemia Major congenital abnormality

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the effect of an olive oil based lipid emulsions used in parenteral nutrition on prostaglandin synthesis and cytokine production in preterm infants, compared with standard lipid emulsion.;Secondary Objective: To compare the effect of olive oil based lipid emulsion on respiratory outcomes (duration of ventilation, disease severity) and on nutritional outcomes (weight gain, triglycerode level);Primary end point(s): 1. Urine prostagalandin metabolite concentration (thromboxane B2 and 6-keto PGF-1 alpha levels) 2. Plasma cytokine concentration (TNF alpha, IL-2, IL-6, IL-8, IL-10)—

Countries

United Kingdom

Outcome results

None listed

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