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A planned interim-analysis revealed increased number of infections in the intervention arm.
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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
| University Hospital, Akershus | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of brain function and growth of infant | Secondary endpoints will include:
| 6 months corrected age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per O Iversen, MD | University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Nordbyhagen | Norway | ||||
| Oslo University Hospital, Rikshospitalet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20096031 | Background | 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. | |
| 19445820 | Background | 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. |
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| ID | Term |
|---|---|
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
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| Oslo |
| Norway |
| Oslo University Hospital, Ullevaal | Oslo | Norway |
| 18519483 | Background | 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. |
| 17718782 | Background | 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. |
| 16452918 | Background | 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. |
| 20624152 | Background | 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. |
| 32964431 | Derived | 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. |
| 29132733 | Derived | 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. |
| 27914187 | Derived | 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. |
| 26922148 | Derived | 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. |
| 23043722 | Derived | 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. |
| D003710 | Demography |
| D011154 | Population Characteristics |