Nutrition, Growth and Development Among Very Preterm Infants

Study Overview
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Brief Summary
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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.

Official Title
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Nutrition, Growth and Development Among Very Preterm Infants

Conditions
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Low Birth Weight Infant

Intervention / Treatment
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* Dietary Supplement: Nutrition


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Participants in this group will receive nutrition from birth and during the hospital stay until discharge according to the routines of the participating institutions. | Dietary Supplement: Nutrition<br>* 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.<br>|
| Active Comparator: Intervention<br>The participants in this group will receive increased supply of energy, protein, vitamin A, docosahexaenoic acid, and arachidonic acid from birth and during the hospital stay until discharge. | Dietary Supplement: Nutrition<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in discharge rate of small-for-gestational age very low birth weight infants | 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%. | 6 months corrected age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of brain function and growth of infant | Secondary endpoints will include: Assessment of brain maturation using MRI. Cognitive measurements. Anthropometric measures and biomarkers to assess body growth and development. Morbidity- (e.g. ROP, BPD, PVL, NEC) and mortality rates. | 6 months corrected age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VLBW, nutrition, vitamin A, long-chain unsaturated fatty acids, growth, cognitive functions, Very low birth weight infants (birth weight below 1,500 grams).