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

May 2, 2017 updated by: Per Ole Iversen, MD, University of Oslo
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Nordbyhagen, Norway
        • Akershus University Hospital
      • Oslo, Norway
        • Oslo University Hospital, Rikshospitalet
      • Oslo, Norway
        • Oslo University Hospital, Ullevaal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
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
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.
Active Comparator: Intervention
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
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of brain function and growth of infant
Time Frame: 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.
6 months corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Collaborators

Oslo University Hospital
University Hospital, Akershus

Investigators

  • Principal Investigator: Per O Iversen, MD, University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

April 12, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 14, 2010

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRENU-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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