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Nutrition Therapy in the Immature Infant (ImNuT)

NCT03555019 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2021-09-08

No results posted yet for this 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.

Conditions

  • Immature Infant
  • Essential Fatty Acid Deficiency

Interventions

DIETARY_SUPPLEMENT

Formulaid

Supplementation with ARA and DHA

DIETARY_SUPPLEMENT

MCT-oil

Supplementation with medium chain fatty acids

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER

  • Umeå University

    collaborator OTHER

  • University of Geneva, Switzerland

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Tom Stiris, MD, ass prof · Departement of Neonatal Intensive care, Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-13
Primary Completion
2021-05-28
Completion
2029-05-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03555019 on ClinicalTrials.gov