Low Birth Weight Infant
Conditions
Keywords
VLBW, nutrition, vitamin A, long-chain unsaturated fatty acids, growth, cognitive functions, Very low birth weight infants (birth weight below 1,500 grams).
Brief summary
The main purpose of this study is to evaluate the effect of increased supply of energy, protein, vitamin A and the long chain polyunsaturated fatty acids docosahexaenoic acid and arachidonic acid on growth, brain maturation and cognitive function.
Interventions
The control (placebo) group will be fed according to the routines of the participating institutions. The intervention (active) group will receive increased supply of energy, protein, vitamin A and long-chain unsaturated fatty acids.
Sponsors
Study design
Eligibility
Inclusion criteria
* Birth weight below 1,500 grams * Written consent to participate from the parents
Exclusion criteria
* Congenital malformations * Clinical syndromes known to affect growth and development * Critical illness and short life expectancy * If participants refuse to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in discharge rate of small-for-gestational age very low birth weight infants | 6 months corrected age | The primary endpoint is to reduce the discharge rate of very low birth weight infants that are small-for-gestational age, from 60 to 40%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of brain function and growth of infant | 6 months corrected age | Secondary endpoints will include: 1. Assessment of brain maturation using MRI. 2. Cognitive measurements. 3. Anthropometric measures and biomarkers to assess body growth and development. 4. Morbidity- (e.g. ROP, BPD, PVL, NEC) and mortality rates. |
Countries
Norway