Nutrition Therapy in the Immature Infant (ImNuT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-13

Study Completion Date

2029-05-30

Brief Summary

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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.

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Detailed Description

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This is a double-blind randomized study. 172 preterm infants with gestational age \< 29 weeks will be enrolled. The intervention group will receive enteral supplementation with essential fatty acids, arachidonic acid (ARA) and docosahexaenoic acid (DHA). The control group will receive standard supplementation with medium-chain triglycerides (MCT-oil). The main hypothesis is that early, enhanced supply of ARA and DHA will improve brain growth and maturation, as compared to standard nutrient supply. Secondary hypotheses are that early, enhanced supply of ARA and DHA will improve quality of growth and cognitive development as well as reduce the frequency of inflammation-related neonatal comorbidities and long-term cardiovascular disease risk. Primary endpoint will be assessed by magnetic resonance imaging (MRI) of the brain at term equivalent age.

Conditions

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Immature Infant Essential Fatty Acid Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind, randomized-controlled. Parallel group, single center trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Formulaid

The intervention group will receive enteral supplementation with Formulaid containing ARA and DHA at a ratio of 2:1, from birth until 36 weeks PMA

Group Type EXPERIMENTAL

Formulaid

Intervention Type DIETARY_SUPPLEMENT

Supplementation with ARA and DHA

MCT-oil

The control group will receive enteral supplementation with MCT oil containing coconut and/or palm kern oil, from birth until 36 weeks PMA

Group Type ACTIVE_COMPARATOR

MCT-oil

Intervention Type DIETARY_SUPPLEMENT

Supplementation with medium chain fatty acids

Interventions

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Formulaid

Supplementation with ARA and DHA

Intervention Type DIETARY_SUPPLEMENT

MCT-oil

Supplementation with medium chain fatty acids

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No