Immature InfantImNuTNCT03555019
Nutrition Therapy in the Immature Infant (ImNuT)
A study testing Formulaid and MCT-oil in people with Immature Infant and Essential Fatty Acid Deficiency, run by Oslo University Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Immature Infant, Essential Fatty Acid Deficiency
- What is being tested?
- Formulaid and MCT-oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteNorway
- Study dates
- 13 Apr 2018to 30 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Nutrition Therapy on Growth, Inflammation and Metabolism in Immature Infants; a Double-blind Randomized, Controlled Trial
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.
Read the 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.
- Conditions
- Immature Infant, Essential Fatty Acid Deficiency
- Being tested
- Formulaid, MCT-oil
- Keywords
- Brain maturation, Postnatal growth
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FormulaidDietary supplement
Supplementation with ARA and DHA
MCT-oilDietary supplement
Supplementation with medium chain fatty acids
| Study group | Role | What they receive |
|---|---|---|
| Formulaid | Experimental | 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 Receives: Dietary Supplement: Formulaid |
| MCT-oil | Active comparator | The control group will receive enteral supplementation with MCT oil containing coconut and/or palm kern oil, from birth until 36 weeks PMA Receives: Dietary Supplement: MCT-oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain maturation assessed by magnetic resonance imaging (MRI)
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
Measured: 40 weeks postmenstrual age (PMA)
Secondary outcomes (17)
Weight gain
Weight measurements, including weight nadir.
Measured: Weight will be recorded until 36 weeks PMA and at 3, 6, 12 and 24 months and 8 years corrected age.
Growth
Length and head circumference (HC).
Measured: Length and HC will be recorded until 36 weeks PMA and at 3, 6, 12 and 24 months and 8 years corrected age.
Body composition
Body composition will be assessed using PEA POD, an air displacement plethysmography system and Dexa Scan.
Measured: At 36 weeks PMA, 3 months and 2 years corrected age
Neonatal morbidities associated with inflammation
Bronchopulmonary dysplasia (BPD), retinopathy of prematurity (ROP), necrotizing enterocolitis (NEC), white matter injury (WMI) of the brain, and late onset septicemia
Measured: From birth til 36 weeks PMA
Cerebral Background Activity evaluated by Electroencephalogram (EEG)
EEG maturational changes will be examined as a function of time and as a function of gestational age
Measured: First week of life, 36 weeks PMA and 2 years corrected age (CA)
Neurodevelopment assessed by standardized motor and cognitive tests
Evaluation of psychomotor development by performing Bayley III and a standardized neurological examination
Measured: 2 years corrected age (CA)
Lung function evaluated by tidal breathing measurements
Tidal breathing measurements include tidal volume, respiratory rate, minute ventilation and fraction of expiratory time to peak tidal expiratory flow to total expiratory time
Measured: 36 weeks PMA, 3 months and 2 years CA
Cardiovascular Health assessed by echocardiography
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.
Measured: First week of life, 2nd week of life, at 36 weeks PMA and 2 years CA
Blood pressure
Measurements of systolic, diastolic and mean pressure
Measured: First week of life and at 36 weeks PMA and 2 years CA
Fatty acid (FA) profiles in blood
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).
Measured: From birth until 36 weeks PMA
Markers of inflammation
Inflammation panels will be used to assess markers of inflammation in fullblood and sputum
Measured: From birth until 36 weeks PMA
Markers of metabolic status
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
Measured: From birth until 36 weeks PMA
Markers of nutritional status in blood
The concentrations of electrolytes, minerals, albumin, alkaline phosphatase, vitamin A and D will be assessed regularly during hospitalization
Measured: From birth until 36 weeks PMA
Micronutrient content in urine
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
Measured: From birth until 36 weeks PMA
Evaluation of nutrient composition of expressed breast milk
Repeated samples of breast milk will be collected for FA analyses, macronutrient content and vitamin A
Measured: From birth until 36 weeks PMA
Gut microbiota
Repeated samples of feces will be used to study the early fecal microbiota
Measured: From birth until 36 weeks PMA
Inflammatory markers in sputum
We will analyze the Expression of a standardized panel of inflammatory markers in collected laryngeal or tracheal secretion
Measured: From birth until 36 weeks PMA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start13 Apr 2018
- Primary completion28 May 2021
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Immature InfantStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized-controlled. Parallel group, single center trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Umeå University, University of Geneva, Switzerland
- Responsible party
- Principal investigator, Sissel Jennifer Moltu, Oslo University Hospital
- Investigators
- Tom Stiris, MD, ass prof, Study director, Departement of Neonatal Intensive care, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555019
- Sponsor's protocol ID
- 2016-003700-31
- Other IDs
- 2016
- Acronym
- ImNuT
- Status last verified
- Sep 2021
- First submitted
- 10 Apr 2018
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Westvik AS, Tomic O, Tscherning C, Moltu SJ. Predicting serum phosphate levels in very preterm infants using machine learning. Front Pediatr. 2026 Jul 15;14:1881474. doi: 10.3389/fped.2026.1881474. eCollection 2026.
PubMed 42528895Gunnarsdottir G, Rossholt ME, Nordvik T, Wendel K, Aas MF, Skarbo AB, Aulie VS, Stiris T, Ramm-Pettersen A, Pfeiffer HC, Moltu SJ. High dose arachidonic and docosahexaenoic acid in very preterm infants and neurodevelopment at 2 years - A double-blind randomized controlled trial. Clin Nutr. 2025 Aug;51:198-205. doi: 10.1016/j.clnu.2025.05.019. Epub 2025 Jun 4.
PubMed 40580806Moltu SJ, Nordvik T, Rossholt ME, Wendel K, Chawla M, Server A, Gunnarsdottir G, Pripp AH, Domellof M, Bratlie M, Aas M, Huppi PS, Lapillonne A, Beyer MK, Stiris T, Maximov II, Geier O, Pfeiffer H. Arachidonic and docosahexaenoic acid supplementation and brain maturation in preterm infants; a double blind RCT. Clin Nutr. 2024 Jan;43(1):176-186. doi: 10.1016/j.clnu.2023.11.037. Epub 2023 Nov 29.
PubMed 38061271Rossholt ME, Bratlie M, Wendel K, Aas MF, Gunnarsdottir G, Fugelseth D, Pripp AH, Domellof M, Stordal K, Stiris T, Moltu SJ. Effect of arachidonic and docosahexaenoic acid supplementation on quality of growth in preterm infants: A secondary analysis of a randomized controlled trial. Clin Nutr. 2023 Dec;42(12):2311-2319. doi: 10.1016/j.clnu.2023.10.005. Epub 2023 Oct 17.
PubMed 37856920Wendel K, Aas MF, Gunnarsdottir G, Rossholt ME, Bratlie M, Nordvik T, Landsend ECS, Fugelseth D, Domellof M, Pripp AH, Stiris T, Moltu SJ. Effect of arachidonic and docosahexaenoic acid supplementation on respiratory outcomes and neonatal morbidities in preterm infants. Clin Nutr. 2023 Jan;42(1):22-28. doi: 10.1016/j.clnu.2022.11.012. Epub 2022 Nov 17.
PubMed 36473425Hortensius LM, Hellstrom W, Savman K, Heckemann RA, Bjorkman-Burtscher IM, Groenendaal F, Andersson MX, Nilsson AK, Tataranno ML, van Elburg RM, Hellstrom A, Benders MJNL. Serum docosahexaenoic acid levels are associated with brain volumes in extremely preterm born infants. Pediatr Res. 2021 Dec;90(6):1177-1185. doi: 10.1038/s41390-021-01645-w. Epub 2021 Aug 14.
PubMed 34392310Wendel K, Pfeiffer HCV, Fugelseth DM, Nestaas E, Domellof M, Skalhegg BS, Elgstoen KBP, Rootwelt H, Pettersen RD, Pripp AH, Stiris T, Moltu SJ; ImNuT Collaboration Group. Effects of nutrition therapy on growth, inflammation and metabolism in immature infants: a study protocol of a double-blind randomized controlled trial (ImNuT). BMC Pediatr. 2021 Jan 7;21(1):19. doi: 10.1186/s12887-020-02425-x.
PubMed 33407269
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutrition Therapy on Growth, Inflammation and Metabolism in Immature Infants; a Double-blind Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03555019
- Acronym / sponsor ID
- ImNuT / 2016-003700-31
- Conditions
- Immature Infant, Essential Fatty Acid Deficiency
- Keywords
- Brain maturation, Postnatal growth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Umeå University, University of Geneva, Switzerland
- Study start
- 13 Apr 2018 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized-controlled. Parallel group, single center trial
| Arm | Type | Receives |
|---|---|---|
| Formulaid | Experimental | Dietary Supplement: FormulaidThe intervention group will receive enteral supplementation with Formulaid containing ARA and DHA at a ratio of 2:1, from birth until 36 weeks PMA |
| MCT-oil | Active comparator | Dietary Supplement: MCT-oilThe control group will receive enteral supplementation with MCT oil containing coconut and/or palm kern oil, from birth until 36 weeks PMA |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FormulaidSupplementation with ARA and DHA | Dietary supplement | Formulaid |
| MCT-oilSupplementation with medium chain fatty acids | Dietary supplement | MCT-oil |
Primary outcome
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
17 secondary outcomes
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.
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.
Body composition
Time frame: At 36 weeks PMA, 3 months and 2 years corrected age
Neonatal morbidities associated with inflammation
Time frame: From birth til 36 weeks PMA
Cerebral Background Activity evaluated by Electroencephalogram (EEG)
Time frame: First week of life, 36 weeks PMA and 2 years corrected age (CA)
Neurodevelopment assessed by standardized motor and cognitive tests
Time frame: 2 years corrected age (CA)
Lung function evaluated by tidal breathing measurements
Time frame: 36 weeks PMA, 3 months and 2 years CA
Cardiovascular Health assessed by echocardiography
Time frame: First week of life, 2nd week of life, at 36 weeks PMA and 2 years CA
Blood pressure
Time frame: First week of life and at 36 weeks PMA and 2 years CA
Fatty acid (FA) profiles in blood
Time frame: From birth until 36 weeks PMA
Markers of inflammation
Time frame: From birth until 36 weeks PMA
Markers of metabolic status
Time frame: From birth until 36 weeks PMA
Markers of nutritional status in blood
Time frame: From birth until 36 weeks PMA
Micronutrient content in urine
Time frame: From birth until 36 weeks PMA
Evaluation of nutrient composition of expressed breast milk
Time frame: From birth until 36 weeks PMA
Gut microbiota
Time frame: From birth until 36 weeks PMA
Inflammatory markers in sputum
Time frame: From birth until 36 weeks PMA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Derived from this study: PubMed 42528895Westvik AS, Tomic O, Tscherning C, Moltu SJ. Predicting serum phosphate levels in very preterm infants using machine learning. Front Pediatr. 2026 Jul 15;14:1881474. doi: 10.3389/fped.2026.1881474. eCollection 2026.
- Derived from this study: PubMed 40580806Gunnarsdottir G, Rossholt ME, Nordvik T, Wendel K, Aas MF, Skarbo AB, Aulie VS, Stiris T, Ramm-Pettersen A, Pfeiffer HC, Moltu SJ. High dose arachidonic and docosahexaenoic acid in very preterm infants and neurodevelopment at 2 years - A double-blind randomized controlled trial. Clin Nutr. 2025 Aug;51:198-205. doi: 10.1016/j.clnu.2025.05.019. Epub 2025 Jun 4.
- Derived from this study: PubMed 38061271Moltu SJ, Nordvik T, Rossholt ME, Wendel K, Chawla M, Server A, Gunnarsdottir G, Pripp AH, Domellof M, Bratlie M, Aas M, Huppi PS, Lapillonne A, Beyer MK, Stiris T, Maximov II, Geier O, Pfeiffer H. Arachidonic and docosahexaenoic acid supplementation and brain maturation in preterm infants; a double blind RCT. Clin Nutr. 2024 Jan;43(1):176-186. doi: 10.1016/j.clnu.2023.11.037. Epub 2023 Nov 29.
- Derived from this study: PubMed 37856920Rossholt ME, Bratlie M, Wendel K, Aas MF, Gunnarsdottir G, Fugelseth D, Pripp AH, Domellof M, Stordal K, Stiris T, Moltu SJ. Effect of arachidonic and docosahexaenoic acid supplementation on quality of growth in preterm infants: A secondary analysis of a randomized controlled trial. Clin Nutr. 2023 Dec;42(12):2311-2319. doi: 10.1016/j.clnu.2023.10.005. Epub 2023 Oct 17.
- Derived from this study: PubMed 36473425Wendel K, Aas MF, Gunnarsdottir G, Rossholt ME, Bratlie M, Nordvik T, Landsend ECS, Fugelseth D, Domellof M, Pripp AH, Stiris T, Moltu SJ. Effect of arachidonic and docosahexaenoic acid supplementation on respiratory outcomes and neonatal morbidities in preterm infants. Clin Nutr. 2023 Jan;42(1):22-28. doi: 10.1016/j.clnu.2022.11.012. Epub 2022 Nov 17.
- Derived from this study: PubMed 34392310Hortensius LM, Hellstrom W, Savman K, Heckemann RA, Bjorkman-Burtscher IM, Groenendaal F, Andersson MX, Nilsson AK, Tataranno ML, van Elburg RM, Hellstrom A, Benders MJNL. Serum docosahexaenoic acid levels are associated with brain volumes in extremely preterm born infants. Pediatr Res. 2021 Dec;90(6):1177-1185. doi: 10.1038/s41390-021-01645-w. Epub 2021 Aug 14.
- Derived from this study: PubMed 33407269Wendel K, Pfeiffer HCV, Fugelseth DM, Nestaas E, Domellof M, Skalhegg BS, Elgstoen KBP, Rootwelt H, Pettersen RD, Pripp AH, Stiris T, Moltu SJ; ImNuT Collaboration Group. Effects of nutrition therapy on growth, inflammation and metabolism in immature infants: a study protocol of a double-blind randomized controlled trial (ImNuT). BMC Pediatr. 2021 Jan 7;21(1):19. doi: 10.1186/s12887-020-02425-x.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Stiris, MD, ass prof study director
Departement of Neonatal Intensive care, Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formulaid and MCT-oil in people with Immature Infant and Essential Fatty Acid Deficiency, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain maturation assessed by magnetic resonance imaging (MRI) (time frame: 40 weeks postmenstrual age (PMA)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03555019, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.