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

U

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)

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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