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Nutrition, Growth and Development Among Very Preterm Infants (PRENU)

Primary Purpose

Low Birth Weight Infant

Status
Terminated
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Nutrition
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Birth Weight Infant focused on measuring VLBW, nutrition, vitamin A, long-chain unsaturated fatty acids, growth, cognitive functions, Very low birth weight infants (birth weight below 1,500 grams).

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Akershus University Hospital
  • Oslo University Hospital, Rikshospitalet
  • Oslo University Hospital, Ullevaal

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Intervention

Arm Description

Participants in this group will receive nutrition from birth and during the hospital stay until discharge according to the routines of the participating institutions.

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.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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.

Full Information

First Posted
April 12, 2010
Last Updated
May 2, 2017
Sponsor
University of Oslo
Collaborators
Oslo University Hospital, University Hospital, Akershus
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1. Study Identification

Unique Protocol Identification Number
NCT01103219
Brief Title
Nutrition, Growth and Development Among Very Preterm Infants
Acronym
PRENU
Official Title
Nutrition, Growth and Development Among Very Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
A planned interim-analysis revealed increased number of infections in the intervention arm.
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo
Collaborators
Oslo University Hospital, University Hospital, Akershus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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).

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Participants in this group will receive nutrition from birth and during the hospital stay until discharge according to the routines of the participating institutions.
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutrition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in discharge rate of small-for-gestational age very low birth weight infants
Description
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%.
Time Frame
6 months corrected age
Secondary Outcome Measure Information:
Title
Evaluation of brain function and growth of infant
Description
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.
Time Frame
6 months corrected age

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per O Iversen, MD
Organizational Affiliation
University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akershus University Hospital
City
Nordbyhagen
Country
Norway
Facility Name
Oslo University Hospital, Rikshospitalet
City
Oslo
Country
Norway
Facility Name
Oslo University Hospital, Ullevaal
City
Oslo
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
20096031
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.
Results Reference
background
PubMed Identifier
19445820
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.
Results Reference
background
PubMed Identifier
18519483
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.
Results Reference
background
PubMed Identifier
17718782
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.
Results Reference
background
PubMed Identifier
16452918
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.
Results Reference
background
PubMed Identifier
20624152
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.
Results Reference
background
PubMed Identifier
32964431
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.
Results Reference
derived
PubMed Identifier
29132733
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.
Results Reference
derived
PubMed Identifier
27914187
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. Erratum In: Food Nutr Res. 2018 Dec 27;62:
Results Reference
derived
PubMed Identifier
26922148
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.
Results Reference
derived
PubMed Identifier
23043722
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.
Results Reference
derived

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Nutrition, Growth and Development Among Very Preterm Infants

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