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

April 12, 2010
August 10, 2012
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 ] [ 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%.
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%.
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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
December 2013
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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01103219
PRENU-1
Yes
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
August 2012

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