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Clinical Trials in Norway / NCT03555019
Active, not recruiting Not applicable

Nutrition Therapy in the Immature Infant (ImNuT)

NCT03555019 · tracked via the Priya Life Science Norway tracker
Sponsor
Oslo University Hospital
Phase
Not applicable
Started
2018-04-13
Last updated
2021-09-08

Condition(s) studied

Immature InfantEssential Fatty Acid Deficiency

Investigational drug(s) / intervention(s)

FormulaidMCT-oil

Formulaid: Supplementation with ARA and DHA

MCT-oil: Supplementation with medium chain fatty acids

Study summary

The primary objective of this double-blind randomized study is to assess the effects of an early, enhanced supply of the essential fatty acids (FAs) arachidonic acid (ARA) and docosahexaenoic acid (DHA) on brain maturation, clinical outcomes and quality of growth in immature infants (gestational age \<29 weeks) as compared to standard nutrient supply.

Eligibility

Sex
ALL
Min age
—
Max age
48 Hours
Healthy volunteers
No
Inclusion Criteria: * Extremely preterm infants born at Oslo University Hospital (OUH) * Gestational age (GA) \< 29 weeks * Less than 48 hours of age at inclusion * Signed informed consent and expected Cooperation of the patients for the treatment and follow up must be obtained and documented according to good clinical practice (GCP) and national/local regulations Exclusion Criteria: * Major congenital malformations which will affect growth and development * Chromosomal abnormalities and other genetic diseases * Critical illness with short life expectancy as defined by the study physician

Primary outcome measure(s)

  • Brain maturation assessed by magnetic resonance imaging (MRI) — 40 weeks postmenstrual age (PMA)
    MRI with spectroscopy (MRS) and diffusion tensor imaging (DTI) will be used to examine myelinisation and quantification of anatomical structures as well as neuronal integrity and inflammation

Trial sites (1)

FacilityCityRegionStatus
Oslo University Hospital Oslo Norway

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03555019 on ClinicalTrials.gov ↗ ← All trials in Norway