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Nutrition, Growth and Development Among Very Preterm Infants

Nutrition, Growth and Development Among Very Preterm Infants

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01103219
Acronym
PRENU
Enrollment
50
Registered
2010-04-14
Start date
2010-08-31
Completion date
2017-05-31
Last updated
2017-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Birth Weight Infant

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

DIETARY_SUPPLEMENTNutrition

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

Oslo University Hospital
CollaboratorOTHER
University Hospital, Akershus
CollaboratorOTHER
University of Oslo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

MeasureTime frameDescription
Reduction in discharge rate of small-for-gestational age very low birth weight infants6 months corrected ageThe 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

MeasureTime frameDescription
Evaluation of brain function and growth of infant6 months corrected ageSecondary 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026