Nutrition Therapy in the Immature Infant (ImNuT)

University of Oslo (UIO)

Status: Active, not recruiting

Conditions: Immature Infant; Essential Fatty Acid Deficiency

Treatments: Dietary Supplement: Formulaid; Dietary Supplement: MCT-oil

Study type: Interventional

Funder types: Other

Identifiers

NCT03555019

2016-003700-31

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 121 patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 2 patient groups

Formulaid

Experimental group

Description:

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

Treatment:

Dietary Supplement: Formulaid

MCT-oil

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: MCT-oil