Nutrition Therapy in the Immature Infant (ImNuT) (ImNuT)
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|ClinicalTrials.gov Identifier: NCT03555019|
Recruitment Status : Active, not recruiting
First Posted : June 13, 2018
Last Update Posted : September 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Immature Infant Essential Fatty Acid Deficiency||Dietary Supplement: Formulaid Dietary Supplement: MCT-oil||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|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|
|Actual Primary Completion Date :||May 28, 2021|
|Estimated Study Completion Date :||May 30, 2029|
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
- 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
- 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.
- 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).
- 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.
- 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
- 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
- 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
- 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
- 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.
- Blood pressure [ Time Frame: First week of life and at 36 weeks PMA and 2 years CA ]Measurements of systolic, diastolic and mean pressure
- 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).
- 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
- 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
- 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
- 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
- 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
- Gut microbiota [ Time Frame: From birth until 36 weeks PMA ]Repeated samples of feces will be used to study the early fecal microbiota
- 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
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
|Oslo University Hospital|
|Study Director:||Tom Stiris, MD, ass prof||Departement of Neonatal Intensive care, Oslo University Hospital|