The effects of the fatty acids arachidonic acid (ARA) and docosahexaenoic acid (DHA) on growth, metabolism and inflammatory response in infants born extremely preterm

Phase 1

• Conditions: To determine whether early and prolonged supply of ARA and DHA improves quality of growth and clinical outcomes in extreme premature infants as compared to our present nutrient supply. By closely assessing nutritional intake, anthropometric measures, clinical outcomes and several biomarkers of inflammation and metabolism, we hope to elucidate mechanisms of inflammation and metabolic mediated damage to major organs such as brain, lung, eye and cardiovascular system of extremely premature infants.; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-003700-31-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-01
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

All extremely preterm infants born at OUH between 01.09.17 and 31.12.19 with GA<29 weeks are eligible.
Oral consent to participate is needed before inclusion. As soon as possible, and at latest within 24 hours of life, the caregivers will be introduced to all study details and the ICF has to be signed before further participation.
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
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

congenital malformations, chromosomal abnormalities and critical illness with short life expectancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To explore potential differences in inflammatory and metabolic pathway responses related to nutrient supply, age, sex, comorbidities, as well as pre- and postnatal growth. <br><br>Secondary hypotheses: Early, enhanced supply of the essential FAs DHA and ARA will improve quality of growth and cognitive development and it will reduce the frequency of inflammation-related neonatal comorbidities and long-term cardiovascular disease risk. <br>;Main Objective: To assess the effects of an early nutritional intervention on clinical outcomes and quality of growth in extreme premature infants (gestational age < 29 weeks). <br>Main hypothesis: Early, enhanced supply of the essential FAs DHA and ARA will improve brain growth and maturation, as compared to standard nutrient supply.<br>;Primary end point(s): Brain maturation assessed by MRI with spectroscopy (MRS) and diffusion tensor imaging (DTI) ;Timepoint(s) of evaluation of this end point: Term equivalent age (+/- 2 weeks).