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Nutrition Therapy in the Immature Infant (ImNuT) (ImNuT)

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ClinicalTrials.gov Identifier: NCT03555019
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Collaborators:
University of Oslo
Umeå University
University of Geneva, Switzerland
Information provided by (Responsible Party):
Sissel Jennifer Moltu, Oslo University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Immature Infant Essential Fatty Acid Deficiency Dietary Supplement: Formulaid Dietary Supplement: MCT-oil Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, randomized-controlled. Parallel group, single center trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Nutrition Therapy on Growth, Inflammation and Metabolism in Immature Infants; a Double-blind Randomized, Controlled Trial
Actual Study Start Date : April 13, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Dietary Supplement: Formulaid
Supplementation with ARA and DHA

Active Comparator: 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
Dietary Supplement: MCT-oil
Supplementation with medium chain fatty acids




Primary Outcome Measures :
  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 Outcome Measures :
  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, 6 months, and 8 years ]
    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 and at 36 weeks PMA ]
    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 ]
    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 from OLINK biosciences 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



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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Time to start treatment with investigational product > 48 h after birth

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555019


Contacts
Contact: Sissel J Moltu, MD, ph.d 0047- 23018780 uxsilt@ous-hf.no
Contact: Kristina Wendel, MD 0047-23018780 krwend@ous-hf.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Sissel J Moltu, MD, PhD    +4722118780    uxsilt@ous-hf.no   
Contact: Tom A Stiris, Professor    +4722118780    uxomst@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Umeå University
University of Geneva, Switzerland
Investigators
Study Director: Tom Stiris, MD, ass prof Departement of Neonatal Intensive care, Oslo University Hospital

Responsible Party: Sissel Jennifer Moltu, MD, PhD, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03555019     History of Changes
Other Study ID Numbers: 2016-003700-31
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be available within 6 months of study completion
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sissel Jennifer Moltu, Oslo University Hospital:
Brain maturation
Postnatal growth