Trial document




drksid header

  DRKS00007685

Trial Description

start of 1:1-Block title

Title

Promoting academic resilience in preterm infants with adaptive computerized training - a multi-center randomised controlled trial

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.uk-essen.de/fit-fuer-die-schule

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The aim of this study is to test if adaptive computerized working memory versus mathematic training improves long-term academic performance of preterm children.
During their first primary and the start of the second school year, children will participate in the training every day for 15-25 minutes over a period of 5 weeks.
Children will be randomized into one of two groups: the first group receives a working memory training, the second group receives a mathematical training. Both trainings continuously adapt to children's performance.
Academic performance (teacher rating) is tested before and after the training and again after 12 months.
In addition, standardized test performance in main subjects (maths, reading, writing) will be assessed as secondary outcome variable.
Amendment due to change in study design; 9.12.15: intervention 2 (mathematical training) instead of placebo, inclusion of late preterm infants until 35+6 weeks.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Prematurity is prospectively related to cognitive and working memory impairments. These deficits are closely associated with preterm children's poor academic achievement: they have higher requirements for special educational needs, lower overall attainment, and more often repeat classes.
This diminishes their life success including lower rates of postsecondary education, higher rates of unemployment, and lower lifetime income.
The objective is to test if adaptive working memory versus mathematic training improves long-term academic performance of preterm children. This is a randomized multi-center trial with two arms. During the first and second year of school, 80 preterm children are randomized into two groups (40:40): adaptive working memory training Cogmed or adaptive mathematical training. The training will be performed over a 5 week period every day. The primary efficacy endpoint is the Teacher Academic Attainment Scale as change from baseline to 12 months.
Amendment due to change in study design; 9.12.15: intervention 2 (mathematical training) instead of placebo, inclusion of late preterm infants until 35+6 weeks.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007685
  •   2015/01/13
  •   [---]*
  •   yes
  •   Approved
  •   134, Ethik-Kommission der Psychologischen Fakultät der Ruhr-Universität Bochum
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   P07.1 -  Other low birth weight
  •   preterm infants, working memory, executive functions
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Cogmed adaptive working memory training (intervention 1), daily (25-30 min) for 5 weeks.
  •   Adaptive mathematical training (intervention 2), daily (10-15 min) for 5 weeks.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

TAAS-Score (Teacher Academic Attainment Scale) for school performance as change from baseline to 12 month.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Performance in standardized mathematic, reading, writing/orthography and working memory tests as change from baseline

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/04/27
  •   80
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   5   Years
  •   7   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

preterm children (28+0 weeks - 35+6 weeks), start school in August 2015, regular elementary school

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

non-correctable handicap, moderat/severe cerebral palsy, hemiparesis, intraventricular hemorrhage > grade 2 and significant leukomalacia/hydrocephalus; multiples, insufficient German language abilities, oppositional defiant disorder, living distance >100km from study centres

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Ruhr-Universität Bochum, Fakultät für Psychologie, Arbeitseinheit Entwicklungspsychologie
    • Ms.  Dr. phil.  Julia  Jäkel 
    • GAFO 04/621
    • 44780  Bochum
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Universitätsklinikum Essen, Direktorin der Klinik für Kinderheilkunde I, Neonatologie, Pädiatrische Intensivmedizin und Neuropädiatrie
    • Ms.  Prof. Dr. med.  Ursula  Felderhoff-Müser 
    • Hufelandstr. 55
    • 45122   Essen
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Vestische Kinder- und Jugendklinik Datteln, Chefärztin Neonatologische und Pädiatrische Intensivmedizin
    • Ms.  Prof. Dr. med.  Claudia  Roll 
    • Dr. Friedrich-Steiner-str. 5
    • 45711  Datteln
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Sana Kliniken DuisburgKlinik für Kinder- und Jugendmedizin
    • Mr.  Dr. med.  Francisco  Brevis 
    • Zu den Rehwiesen 9-11
    • 47055  Duisburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Elisabeth Krankenhaus EssenKlinik für Neu- und Frühgeborene
    • Mr.  Dr. med.  Dariusz  Michna 
    • Klara-Kopp-Weg 1
    • 45138  Essen
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Universitätsklinikum DüsseldorfKlinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
    • Mr.  Prof. Dr. med.  Thomas  Höhn 
    • Moorenstr. 5
    • 40225  Düsseldorf
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Essen, Oberärztin und Prüfärztin der Klinik für Kinderheilkunde I, Neonatologie
    • Ms.  Dr.med.  Britta  Hüning 
    • Hufelandstr. 55
    • 45122  Essen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Essen, Klinik für Kinderheilkunde I, Studienkoordination Neonatologie
    • Ms.  Frauke  Dransfeld 
    • Hufelandstr. 55
    • 45122  Essen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Direktor, Mercator Research Center Ruhr GmbH
    • Mr.  Prof. Dr.  Winfried  Schulze 
    • Huyssenallee 66-68
    • 45128  Essen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Universitätsklinikum Essen, Zentrum für Kinder- und Jugendmedizin, Klinik für Kinderheilkunde I
    • Ms.  Prof. Dr. med.  Ursula  Felderhoff-Müser 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2017/12/20
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.