Infant, Very Low Birth WeightNCT01518452
Computerized Working Memory Training in Very-low-birth-weight Children at Preschool Age
A study testing Cogmed JM working memory training and Cogmed JM working memory training after waiting in people with Infant, Very Low Birth Weight, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Infant, Very Low Birth Weight
- What is being tested?
- Cogmed JM working memory training and Cogmed JM working memory training after waiting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- VLBW (birth weight ≤ 1500 grams)
- preschool child
- born at St. Olav's University Hospital in Trondheim in 2005 and 2006
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computerized Working Memory Training Evaluated With Clinical Assessments and Quantitative EEG in Very-low-birth-weight (VLBW) Children at Preschool Age
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.
Read the detailed description
Children born preterm are at increased risk of neurological disabilities due to perinatal brain damage. During the last ten years an increasing number of especially extremely low birth weight (ELBW: BW ≤ 1000g) children has survived, and one might wonder whether this has lead to increased amount of brain pathology and impairments among survivors. Major impairments including cerebral palsy, mental retardation and impaired vision and hearing are most common in children born extremely preterm (gestational age below 28 weeks). In addition to this, a large part of survivors after preterm birth will experience motor problems, cognitive dysfunctions, psychiatric and behavioural problems of varying severity.
In our previous research we have found significant deficits in working memory in very preterm born children, and this seems to have a strong influence on cognitive functioning. During the last years, several studies have shown that working memory skills can be trained, and training working memory to improve cognition and executive functions is regarded as one of the major steps forward in neuroscience in recent years.
The working memory training program version for preschoolers, Cogmed JM, has recently been launched. Healthy preschoolers trained on working memory improved significantly on trained tasks but also on non-trained tests of spatial and verbal working memory, as well as transfer effects on attention. The preschool version of the program has not yet been administered to preterm born or other neurologic high risk children in this age group.
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. We hypothesise 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. We also hypothesise that training may benefit additional executive functions.
The children in the study will be divided into two subgroups (15/15 children). Subgroup A will start training, while subgroup B waits during this first training period. Subgroup B will therefore act as a control group. After 8 weeks subgroup B will then start training. This is in agreement with the so-called Stepped Wedge design (Brown and Lilford 2006).
- Conditions
- Infant, Very Low Birth Weight
- Being tested
- Cogmed JM working memory training, Cogmed JM working memory training after waiting
- Keywords
- working memory training, computerized, clinical assessment, quantitative EEG, child, preschool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cogmed JM working memory trainingBehavioural
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
Cogmed JM working memory training after waitingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| working memory training | Experimental | Cogmed JM working memory training Receives: Behavioral: Cogmed JM working memory training |
| delayed working memory training | Experimental | Cogmed JM working memory training after 8 weeks waiting Receives: Behavioral: Cogmed JM working memory training after waiting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (3)
behavioral function
Vineland adaptive behaviour scales (survey form)
Measured: 6 months
executive function
The ADHD Rating Scale-IV (parents report)
Measured: 6 months
anxiety as judged by parents
The Screen for Child Anxiety Related Emotional Disorders (SCARED- parent report); Preschool Anxiety Scale (parent report)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startApr 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant, Very Low Birth WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon Skranes, PhD prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518452
- Sponsor's protocol ID
- 2011/532
- Status last verified
- Jun 2017
- First submitted
- 10 Jan 2012
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23400616Grunewaldt 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.
PubMed 26140426
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Working Memory Training Evaluated With Clinical Assessments and Quantitative EEG in Very-low-birth-weight (VLBW) Children at Preschool Age
- ClinicalTrials.gov ID
- NCT01518452
- Acronym / sponsor ID
- 2011/532
- Conditions
- Infant, Very Low Birth Weight
- Keywords
- working memory training, computerized, clinical assessment, quantitative EEG, child, preschool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 26 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Children born preterm are at increased risk of neurological disabilities due to perinatal brain damage. During the last ten years an increasing number of especially extremely low birth weight (ELBW: BW ≤ 1000g) children has survived, and one might wonder whether this has lead to increased amount of brain pathology and impairments among survivors. Major impairments including cerebral palsy, mental retardation and impaired vision and hearing are most common in children born extremely preterm (gestational age below 28 weeks). In addition to this, a large part of survivors after preterm birth will experience motor problems, cognitive dysfunctions, psychiatric and behavioural problems of varying severity.
In our previous research we have found significant deficits in working memory in very preterm born children, and this seems to have a strong influence on cognitive functioning. During the last years, several studies have shown that working memory skills can be trained, and training working memory to improve cognition and executive functions is regarded as one of the major steps forward in neuroscience in recent years.
The working memory training program version for preschoolers, Cogmed JM, has recently been launched. Healthy preschoolers trained on working memory improved significantly on trained tasks but also on non-trained tests of spatial and verbal working memory, as well as transfer effects on attention. The preschool version of the program has not yet been administered to preterm born or other neurologic high risk children in this age group.
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. We hypothesise 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. We also hypothesise that training may benefit additional executive functions.
The children in the study will be divided into two subgroups (15/15 children). Subgroup A will start training, while subgroup B waits during this first training period. Subgroup B will therefore act as a control group. After 8 weeks subgroup B will then start training. This is in agreement with the so-called Stepped Wedge design (Brown and Lilford 2006).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| working memory training | Experimental | Behavioral: Cogmed JM working memory trainingCogmed JM working memory training |
| delayed working memory training | Experimental | Behavioral: Cogmed JM working memory training after waitingCogmed JM working memory training after 8 weeks waiting |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- VLBW (birth weight ≤ 1500 grams)
- preschool child
- born at St. Olav's University Hospital in Trondheim in 2005 and 2006
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cogmed JM working memory trainingdaily 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 | Behavioural | working memory training |
| Cogmed JM working memory training after waitingWaiting 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 | Behavioural | delayed working memory training |
Primary outcome
working memory capacity
Time frame: 6 months
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)
3 secondary outcomes
behavioral function
Time frame: 6 months
executive function
Time frame: 6 months
anxiety as judged by parents
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Results publication: PubMed 23400616Grunewaldt 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.
- Results publication: PubMed 26140426Grunewaldt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Skranes, PhD prof study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cogmed JM working memory training and Cogmed JM working memory training after waiting in people with Infant, Very Low Birth Weight, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
working memory capacity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01518452, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017; AzTrials last refreshed its copy on 28 Oct 2026.