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

Phase 1

Conditions: PrematurityParenteral nutrition

Registration Number: EUCTR2004-001653-28-GB

Lead Sponsor: The Leeds teaching Hospitals NHS trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 50

Inclusion Criteria

Preterm <37 weeks gestational age
Requiring intensive care
Requiring parenteral nutrition
Informed parental consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

>=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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>2. Plasma cytokine concentration (TNF alpha, IL-2, IL-6, IL-8, IL-10)

Secondary Outcome Measures