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

This study has been terminated.

(A planned interim-analysis revealed increased number of infections in the intervention arm.)

Sponsor:

Collaborators:

Oslo University Hospital

University Hospital, Akershus

Information provided by (Responsible Party):

Per Ole Iversen, MD, University of Oslo

ClinicalTrials.gov Identifier:

NCT01103219

First received: April 12, 2010

Last updated: August 10, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 12, 2010

Last Updated Date

August 10, 2012

Start Date ^ICMJE

August 2010

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reduction in discharge rate of small-for-gestational age very low birth weight infants [ Time Frame: 6 months corrected age ] [ Designated as safety issue: No ]

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%.

Original Primary Outcome Measures ^ICMJE

Reduction in discharge rate of small-for-gestational age very low birth weight infants [ Time Frame: 6 months corrected age ] [ Designated as safety issue: No ]

The primary endpoint is to reduce the discharge rate of very low birth weight infants taht are small-for-gestational age, from 60 to 40%.

Change History

Complete list of historical versions of study NCT01103219 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluation of brain function and growth of infant [ Time Frame: 6 months corrected age ] [ Designated as safety issue: Yes ]

Secondary endpoints will include:

Assessment of brain maturation using MRI.
Cognitive measurements.
Anthropometric measures and biomarkers to assess body growth and development.
Morbidity- (e.g. ROP, BPD, PVL, NEC) and mortality rates.

Original Secondary Outcome Measures ^ICMJE

Evaluation of brain function and growth of infant [ Time Frame: 6 months corrected age ] [ Designated as safety issue: Yes ]

Secondary endpoints will include:

Assessment of brain maturation using MRI.
Cognitive examination using electrophysiologial methods and questionnaires.
Anthropometric measures and biomarkers to assess body growth and development

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Nutrition, Growth and Development Among Very Preterm Infants

Official Title ^ICMJE

Nutrition, Growth and Development Among Very Preterm Infants

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

Low Birth Weight Infant

Intervention ^ICMJE

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.

Study Arm (s)

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.

Intervention: Dietary Supplement: Nutrition
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.

Intervention: Dietary Supplement: Nutrition

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT01103219

Other Study ID Numbers ^ICMJE

PRENU-1

Has Data Monitoring Committee

Yes

Responsible Party

Per Ole Iversen, MD, University of Oslo

Study Sponsor ^ICMJE

University of Oslo

Collaborators ^ICMJE

Oslo University Hospital
University Hospital, Akershus

Investigators ^ICMJE

Principal Investigator:

Per O Iversen, MD

University of Oslo

Information Provided By

University of Oslo

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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