Nutrition, Growth and Development Among Very Preterm Infants (PRENU)

University of Oslo

Status and phase: Terminated; Phase 3

Conditions: Low Birth Weight Infant

Treatments: Dietary Supplement: Nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT01103219

PRENU-1

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Participants in this group will receive nutrition from birth and during the hospital stay until discharge according to the routines of the participating institutions.

Treatment:

Dietary Supplement: Nutrition

Intervention

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Nutrition