NCT01103219

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

April 12, 2010

Last Update Submit

May 2, 2017

Conditions

Low Birth Weight Infant

Keywords

VLBWnutritionvitamin Along-chain unsaturated fatty acidsgrowthcognitive functionsVery low birth weight infants (birth weight below 1,500 grams).

Outcome Measures

Primary Outcomes (1)

  • Reduction in discharge rate of small-for-gestational age very low birth weight infants

    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%.

    6 months corrected age

Secondary Outcomes (1)

  • Evaluation of brain function and growth of infant

    6 months corrected age

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Intervention

ACTIVE COMPARATOR

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

Interventions

NutritionDIETARY_SUPPLEMENT

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.

ControlIntervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Birth weight below 1,500 grams
  • Written consent to participate from the parents

You may not qualify if:

  • Congenital malformations
  • Clinical syndromes known to affect growth and development
  • Critical illness and short life expectancy
  • If participants refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Akershus University Hospital

Nordbyhagen, Norway

Location

Oslo University Hospital, Rikshospitalet

Oslo, Norway

Location

Oslo University Hospital, Ullevaal

Oslo, Norway

Location

Related Publications (11)

  • Westerberg AC, Henriksen C, Ellingvag A, Veierod MB, Juliusson PB, Nakstad B, Aurvag AK, Ronnestad A, Gronn M, Iversen PO, Drevon CA. First year growth among very low birth weight infants. Acta Paediatr. 2010 Apr;99(4):556-62. doi: 10.1111/j.1651-2227.2009.01667.x. Epub 2010 Jan 20.

    PMID: 20096031BACKGROUND

  • Henriksen C, Westerberg AC, Ronnestad A, Nakstad B, Veierod 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. doi: 10.1017/S0007114509371755. Epub 2009 May 18.

    PMID: 19445820BACKGROUND

  • Henriksen C, Haugholt K, Lindgren M, Aurvag AK, Ronnestad A, Gronn 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. doi: 10.1542/peds.2007-1511.

    PMID: 18519483BACKGROUND

  • Aurvag 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. doi: 10.1111/j.1651-2227.2007.00445.x.

    PMID: 17718782BACKGROUND

  • Henriksen C, Helland IB, Ronnestad A, Gronn 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. doi: 10.1038/sj.ejcn.1602379. Epub 2006 Feb 1.

    PMID: 16452918BACKGROUND

  • Westerberg AC, Schei R, Henriksen C, Smith L, Veierod MB, Drevon CA, Iversen PO. Attention among very low birth weight infants following early supplementation with docosahexaenoic and arachidonic acid. Acta Paediatr. 2011 Jan;100(1):47-52. doi: 10.1111/j.1651-2227.2010.01946.x.

    PMID: 20624152BACKGROUND

  • Amissah EA, Brown J, Harding JE. Protein supplementation of human milk for promoting growth in preterm infants. Cochrane Database Syst Rev. 2020 Sep 23;9(9):CD000433. doi: 10.1002/14651858.CD000433.pub3.

    PMID: 32964431DERIVED

  • Strommen K, Haag A, Moltu SJ, Veierod MB, Blakstad EW, Nakstad B, Almaas AN, Braekke K, Ronnestad AE, Daniel H, Drevon CA, Iversen PO. Enhanced nutrient supply to very low birth weight infants is associated with higher blood amino acid concentrations and improved growth. Clin Nutr ESPEN. 2017 Apr;18:16-22. doi: 10.1016/j.clnesp.2017.01.003. Epub 2017 Feb 13.

    PMID: 29132733DERIVED

  • Blakstad EW, Moltu SJ, Nakstad B, Veierod MB, Strommen K, Juliusson PB, Almaas AN, Ronnestad AE, Braekke K, Drevon CA, Iversen PO. Enhanced nutrition improves growth and increases blood adiponectin concentrations in very low birth weight infants. Food Nutr Res. 2016 Dec 1;60:33171. doi: 10.3402/fnr.v60.33171. eCollection 2016.

    PMID: 27914187DERIVED

  • Strommen K, Lyche JL, Blakstad EW, Moltu SJ, Veierod MB, Almaas AN, Sakhi AK, Thomsen C, Nakstad B, Braekke K, Ronnestad AE, Drevon CA, Iversen PO. Increased levels of phthalates in very low birth weight infants with septicemia and bronchopulmonary dysplasia. Environ Int. 2016 Apr-May;89-90:228-34. doi: 10.1016/j.envint.2016.01.024. Epub 2016 Feb 26.

    PMID: 26922148DERIVED

  • Moltu SJ, Strommen K, Blakstad EW, Almaas AN, Westerberg AC, Braekke K, Ronnestad A, Nakstad B, Berg JP, Veierod 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.

    PMID: 23043722DERIVED

MeSH Terms

Interventions

Nutritional Status

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Per O Iversen, MD

    University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 14, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2012

Study Completion

May 1, 2017

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

NO(3)