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

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:

MedlinePlus related topics: Birth Weight Premature Babies Vitamin A

Drug Information available for: Retinol Vitamin A palmitate Vitamin A

U.S. FDA Resources

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

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:

Westerberg AC, Henriksen C, Ellingvåg A, Veierød MB, Júlíusson PB, Nakstad B, Aurvåg AK, Rønnestad A, Grønn M, Iversen PO, Drevon CA. First year growth among very low birth weight infants. Acta Paediatr. 2010 Apr;99(4):556-62. Epub 2010 Jan 20.

Henriksen C, Westerberg AC, Rønnestad A, Nakstad B, Veierød MB, Drevon CA, Iversen PO. Growth and nutrient intake among very-low-birth-weight infants fed fortified human milk during hospitalisation. Br J Nutr. 2009 Oct;102(8):1179-86. Epub 2009 May 18.

Henriksen C, Haugholt K, Lindgren M, Aurvåg AK, Rønnestad A, Grønn M, Solberg R, Moen A, Nakstad B, Berge RK, Smith L, Iversen PO, Drevon CA. Improved cognitive development among preterm infants attributable to early supplementation of human milk with docosahexaenoic acid and arachidonic acid. Pediatrics. 2008 Jun;121(6):1137-45.

Aurvåg AK, Henriksen C, Drevon CA, Iversen PO, Nakstad B. Improved vitamin A supplementation regimen for breastfed very low birth weight infants. Acta Paediatr. 2007 Sep;96(9):1296-302.

Henriksen C, Helland IB, Rønnestad A, Grønn M, Iversen PO, Drevon CA. Fat-soluble vitamins in breast-fed preterm and term infants. Eur J Clin Nutr. 2006 Jun;60(6):756-62. Epub 2006 Feb 1.

Westerberg AC, Schei R, Henriksen C, Smith L, Veierød MB, Drevon CA, Iversen PO. Attention among very low birth weight infants following early supplementation with docosahexaenoic and arachidonic acid. Acta Paediatr. 2010 Jul 9; [Epub ahead of print]

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Moltu SJ, Strømmen K, Blakstad EW, Almaas AN, Westerberg AC, Brække K, Rønnestad A, Nakstad B, Berg JP, Veierød MB, Haaland K, Iversen PO, Drevon CA. Enhanced feeding in very-low-birth-weight infants may cause electrolyte disturbances and septicemia--a randomized, controlled trial. Clin Nutr. 2013 Apr;32(2):207-12. doi: 10.1016/j.clnu.2012.09.004. Epub 2012 Sep 21.

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 May 19, 2013

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