Nutrition, Growth and Development Among Very Preterm Infants

Low Birth Weight Infant Clinical Trial

— PRENU  

Official title:

Nutrition, Growth and Development Among Very Preterm Infants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01103219
• Other study ID #: PRENU-1
• Status: Terminated
• Phase: Phase 3
• First received: April 12, 2010
• Last updated: May 2, 2017
• Start date: August 2010
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: May 2017
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Low Birth Weight Infant

Intervention

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.

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Nordbyhagen
Norway	Oslo University Hospital, Rikshospitalet	Oslo
Norway	Oslo University Hospital, Ullevaal	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
University of Oslo	Oslo University Hospital, University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

References & Publications (6)

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. — View Citation

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. doi: 10.1542/peds.2007-1511. — View Citation

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. — View Citation

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. doi: 10.1017/S0007114509371755. Epub 2009 May 18. — View Citation

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. doi: 10.1111/j.1651-2227.2009.01667.x. Epub 2010 Jan 20. — View Citation

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. 2011 Jan;100(1):47-52. doi: 10.1111/j.1651-2227.2010.01946.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of brain function and growth of infant	Secondary endpoints will include: Assessment of brain maturation using MRI.; Cognitive measurements.; Anthropometric measures and biomarkers to assess body growth and development.; Morbidity- (e.g. ROP, BPD, PVL, NEC) and mortality rates.	6 months corrected age