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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:
ClinicalTrials.gov Identifier:
NCT01103219
First Posted: April 14, 2010
Last Update Posted: May 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Oslo University Hospital
University Hospital, Akershus
Information provided by (Responsible Party):
Per Ole Iversen, MD, University of Oslo
April 12, 2010
April 14, 2010
May 3, 2017
August 2010
December 2012   (Final data collection date for primary outcome measure)
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%.
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 taht are small-for-gestational age, from 60 to 40%.
Complete list of historical versions of study NCT01103219 on ClinicalTrials.gov Archive Site
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.
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 examination using electrophysiologial methods and questionnaires.
  3. Anthropometric measures and biomarkers to assess body growth and development
Not Provided
Not Provided
 
Nutrition, Growth and Development Among Very Preterm Infants
Nutrition, Growth and Development Among Very Preterm Infants
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Low Birth Weight Infant
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.
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
May 2017
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01103219
PRENU-1
Yes
Not Provided
Not Provided
Per Ole Iversen, MD, University of Oslo
University of Oslo
  • Oslo University Hospital
  • University Hospital, Akershus
Principal Investigator: Per O Iversen, MD University of Oslo
University of Oslo
May 2017

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