Clinical trial NCT01103219: Nutrition, Growth and Development Among Very Preterm Infants
Official title: Nutrition, Growth and Development Among Very Preterm Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Low Birth Weight Infant
Keywords: VLBW
nutrition
vitamin A
long-chain unsaturated fatty acids
growth
cognitive functions
Very low birth weight infants (birth weight below 1,500 grams).
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: University Hospital, Akershus
First posted: 2010-04-14
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Reduction in discharge rate of small-for-gestational age very low birth weight infants
timeFrame: 6 months corrected age
Secondary outcomes:
measure: Evaluation of brain function and growth of infant
timeFrame: 6 months corrected age
Other outcomes:
Locations:
city: Nordbyhagen
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevaal
Study officials:
affiliation: University of Oslo
name: Per O Iversen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.