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NCT Number: NCT03555019

Nutrition Therapy in the Immature Infant (ImNuT)

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Immature Infant Essential Fatty Acid Deficiency Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Formulaid

Dietary Supplement

Supplementation with ARA and DHA

MCT-oil

Dietary Supplement

Supplementation with medium chain fatty acids

Primary outcomes

  1. Brain maturation assessed by magnetic resonance imaging (MRI)

    Time frame: 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

Secondary outcomes

  1. Weight gain

    Time frame: Weight will be recorded until 36 weeks PMA and at 3, 6, 12 and 24 months and 8 years corrected age.

    Weight measurements, including weight nadir.

  2. Growth

    Time frame: Length and HC will be recorded until 36 weeks PMA and at 3, 6, 12 and 24 months and 8 years corrected age.

    Length and head circumference (HC).

  3. Body composition

    Time frame: At 36 weeks PMA, 3 months and 2 years corrected age

    Body composition will be assessed using PEA POD, an air displacement plethysmography system and Dexa Scan.

  4. Neonatal morbidities associated with inflammation

    Time frame: From birth til 36 weeks PMA

    Bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), white matter injury (WMI) of the brain, and late onset septicemia

  5. Cerebral Background Activity evaluated by Electroencephalogram (EEG)

    Time frame: First week of life, 36 weeks PMA and 2 years corrected age (CA)

    EEG maturational changes will be examined as a function of time and as a function of gestational age

  6. Neurodevelopment assessed by standardized motor and cognitive tests

    Time frame: 2 years corrected age (CA)

    Evaluation of psychomotor development by performing Bayley III and a standardized neurological examination

  7. Lung function evaluated by tidal breathing measurements

    Time frame: 36 weeks PMA, 3 months and 2 years CA

    Tidal breathing measurements include tidal volume, respiratory rate, minute ventilation and fraction of expiratory time to peak tidal expiratory flow to total expiratory time

  8. Cardiovascular Health assessed by echocardiography

    Time frame: First week of life, 2nd week of life, at 36 weeks PMA and 2 years CA

    Echocardiography will be used to follow the transition from fetal to completed neonatal circulation, to measure superior vena cava flow, and to study mycardial function by the use of conventional two-dimensional echocardiography and tissue Doppler imaging.

  9. Blood pressure

    Time frame: First week of life and at 36 weeks PMA and 2 years CA

    Measurements of systolic, diastolic and mean pressure

  10. Fatty acid (FA) profiles in blood

    Time frame: From birth until 36 weeks PMA

    Repeated dried blood spots (DBS) samples with approximately 10 µL blood will be collected for FA analyses. These analyses are important for assessing efficacy and protocol compliance. We will also collect 10 µL of fullblood for assessment of total lipid profile (Lipidomics).

  11. Markers of inflammation

    Time frame: From birth until 36 weeks PMA

    Inflammation panels will be used to assess markers of inflammation in fullblood and sputum

  12. Markers of metabolic status

    Time frame: From birth until 36 weeks PMA

    Metabolic pathway analyses (http://omictools.com/metabolic-pathways-category) will be performed to analyse and describe the metabolic conditions of the infants during hospitalization. Metabolites outside the standard clinical chemistry parameters will also be investigated ("untargeted metabolomics). Metabolomics will be performed by the use of dried blood spot samples

  13. Markers of nutritional status in blood

    Time frame: From birth until 36 weeks PMA

    The concentrations of electrolytes, minerals, albumin, alkaline phosphatase, vitamin A and D will be assessed regularly during hospitalization

  14. Micronutrient content in urine

    Time frame: From birth until 36 weeks PMA

    Spot urine will be obtained regularly to study the changes in electrolyte- and mineral homeostasis during the first week of life as well as during the phase of steady growth

  15. Evaluation of nutrient composition of expressed breast milk

    Time frame: From birth until 36 weeks PMA

    Repeated samples of breast milk will be collected for FA analyses, macronutrient content and vitamin A

  16. Gut microbiota

    Time frame: From birth until 36 weeks PMA

    Repeated samples of feces will be used to study the early fecal microbiota

  17. Inflammatory markers in sputum

    Time frame: From birth until 36 weeks PMA

    We will analyze the Expression of a standardized panel of inflammatory markers in collected laryngeal or tracheal secretion

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Umeå University
  • University of Geneva, Switzerland
  • University of Oslo

Registry information

Official study title

Effects of Nutrition Therapy on Growth, Inflammation and Metabolism in Immature Infants; a Double-blind Randomized, Controlled Trial

Acronym: ImNuT

Important dates

Study start
2018
Primary completion
2021
Study completion
2029
First posted
Jun 13, 2018
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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