Nutrition, Growth and Development Among Very Preterm Infants

Phase 3

Terminated

• Conditions: Low Birth Weight Infant
• Interventions: Dietary Supplement: Nutrition

• Registration Number: NCT01103219
• Lead Sponsor: University of Oslo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-14
• Study Start: 2010-08
• Primary Completion: 2012-12
• Status Verified: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Akershus University Hospital; 🇳🇴 Nordbyhagen, Norway

Oslo University Hospital, Ullevaal; 🇳🇴 Oslo, Norway

Oslo University Hospital, Rikshospitalet; 🇳🇴 Oslo, Norway