Trials / Active Not Recruiting
Active Not RecruitingNCT03555019
Nutrition Therapy in the Immature Infant (ImNuT)
Effects of Nutrition Therapy on Growth, Inflammation and Metabolism in Immature Infants; a Double-blind Randomized, Controlled Trial
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 121 (actual)
- Sponsor
- Oslo University Hospital · Academic / Other
- Sex
- All
- Age
- 48 Hours
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Formulaid | Supplementation with ARA and DHA |
| DIETARY_SUPPLEMENT | MCT-oil | Supplementation with medium chain fatty acids |
Timeline
- Start date
- 2018-04-13
- Primary completion
- 2021-05-28
- Completion
- 2029-05-30
- First posted
- 2018-06-13
- Last updated
- 2021-09-08
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT03555019. Inclusion in this directory is not an endorsement.