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
  Purpose

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.


Condition Intervention Phase
Low Birth Weight Infant
Dietary Supplement: Nutrition
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Nutrition, Growth and Development Among Very Preterm Infants

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • 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%.


Secondary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: August 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103219

Locations
Norway
Akershus University Hospital
Nordbyhagen, Norway
Oslo University Hospital, Rikshospitalet
Oslo, Norway
Oslo University Hospital, Ullevaal
Oslo, Norway
Sponsors and Collaborators
University of Oslo
Oslo University Hospital
University Hospital, Akershus
Investigators
Principal Investigator: Per O Iversen, MD University of Oslo
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Per Ole Iversen, MD, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01103219     History of Changes
Other Study ID Numbers: PRENU-1
Study First Received: April 12, 2010
Last Updated: August 10, 2012
Health Authority: Norway: The National Committee for Medical and Health

Keywords provided by University of Oslo:
VLBW
nutrition
vitamin A
long-chain unsaturated fatty acids
growth
cognitive functions
Very low birth weight infants (birth weight below 1,500 grams).

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Vitamin A
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014