NCT01518452

Brief Summary

The main aim of this prospective interventional study is to compare quantitative EEG findings and cognitive and neuropsychological test results before and after training with the Cogmed JM program in a group of very-low-birth-weight children in preschool age, i.e. ages 5-6 years. The investigators hypothesize that the children in the study may respond positively to the computerized training and improve working memory, but probably to different degrees depending on the underlying neurological condition. The investigators also hypothesize that training may benefit additional executive functions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

January 10, 2012

Last Update Submit

June 13, 2017

Conditions

Infant, Very Low Birth Weight

Keywords

working memory training, computerizedclinical assessmentquantitative EEGchild, preschool

Outcome Measures

Primary Outcomes (1)

  • working memory capacity

    Automated Working Memory Assessment (AWMA)(visual working memory); digit span (from WISC-IV); Repetition of scentences (from NEPSY battery); Remembering and oral story (from NEPSY battery); Remembering faces (from NEPSY battery)

    6 months

Secondary Outcomes (3)

  • behavioral function

    6 months

  • executive function

    6 months

  • anxiety as judged by parents

    6 months

Study Arms (2)

working memory training

EXPERIMENTAL

Cogmed JM working memory training

Behavioral: Cogmed JM working memory training

delayed working memory training

EXPERIMENTAL

Cogmed JM working memory training after 8 weeks waiting

Behavioral: Cogmed JM working memory training after waiting

Interventions

Cogmed JM working memory trainingBEHAVIORAL

daily training for 5 weeks on a computerized program for training working memory; a total of 25 training sessions. Program: Cogmed JM - preschool version of program: 15-20 minutes training per day

working memory training
Cogmed JM working memory training after waitingBEHAVIORAL

Waiting after baseline testing for 8 weeks. Daily training on a computerized program for training working memory for 5 weeks. 25 training sessions in total. Program: Cogmed JM - preschool version of program: 15-20 minutes training per day

delayed working memory training

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • VLBW (birth weight ≤ 1500 grams)
  • preschool child
  • born at St. Olav's University Hospital in Trondheim in 2005 and 2006

You may not qualify if:

  • birth weight \>1500 grams
  • diagnosed genetic syndromes
  • severe cerebral palsy with totally impaired bilateral hand function (GMFCS - gross motor function classification scale level V)
  • blindness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (2)

  • Grunewaldt KH, Lohaugen GC, Austeng D, Brubakk AM, Skranes J. Working memory training improves cognitive function in VLBW preschoolers. Pediatrics. 2013 Mar;131(3):e747-54. doi: 10.1542/peds.2012-1965. Epub 2013 Feb 11.

    PMID: 23400616RESULT

  • Grunewaldt KH, Skranes J, Brubakk AM, Lahaugen GC. Computerized working memory training has positive long-term effect in very low birthweight preschool children. Dev Med Child Neurol. 2016 Feb;58(2):195-201. doi: 10.1111/dmcn.12841. Epub 2015 Jul 3.

    PMID: 26140426RESULT

Study Officials

  • Jon Skranes, PhD prof

    Norwegian University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2012

First Posted

January 26, 2012

Study Start

April 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 14, 2017

Record last verified: 2017-06

Locations

NO(1)