Computerized Working Memory Training in Very-low-birth-weight Children at Preschool Age

NCT ID: NCT01518452

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

working memory training

Cogmed JM working memory training

Group Type: EXPERIMENTAL

Cogmed JM working memory training

Intervention Type: BEHAVIORAL

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

delayed working memory training

Cogmed JM working memory training after 8 weeks waiting

Group Type: EXPERIMENTAL

Cogmed JM working memory training after waiting

Intervention Type: BEHAVIORAL

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

Interventions

Cogmed JM working memory training

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

Intervention Type: BEHAVIORAL

Cogmed JM working memory training after waiting

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon Skranes, PhD prof

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

St Olavs Hospital

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 23400616 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26140426 (View on PubMed)

Other Identifiers

2011/532

Identifier Type: -

Identifier Source: org_study_id