Nutrition, Growth and Development Among Very Preterm Infants
NCT ID: NCT01103219
Last Updated: 2017-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
50 participants
INTERVENTIONAL
2010-08-31
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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 Criteria
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Inclusion Criteria
* Written consent to participate from the parents
Exclusion Criteria
* Clinical syndromes known to affect growth and development
* Critical illness and short life expectancy
* If participants refuse to participate
ALL
No
Sponsors
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Oslo University Hospital
OTHER
University Hospital, Akershus
OTHER
University of Oslo
OTHER
Responsible Party
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Per Ole Iversen, MD
Professor
Principal Investigators
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Per O Iversen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oslo
Locations
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Akershus University Hospital
Nordbyhagen, , Norway
Oslo University Hospital, Rikshospitalet
Oslo, , Norway
Oslo University Hospital, Ullevaal
Oslo, , Norway
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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PRENU-1
Identifier Type: -
Identifier Source: org_study_id
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