title: Home-based, early intervention with mechatronic toys for preterm infants at risk of neurodevelopmental disorders (CARETOY): a RCT protocol.
abstract: BACKGROUND
  Preterm infants are at risk for neurodevelopmental disorders, including motor, cognitive or behavioural problems, which may potentially be modified by early intervention. The EU CareToy Project Consortium (http://www.caretoy.eu) has developed a new modular system for intensive, individualized, home-based and family-centred early intervention, managed remotely by rehabilitation staff. A randomised controlled trial (RCT) has been designed to evaluate the efficacy of CareToy training in a first sample of low-risk preterm infants.
  
  
  METHODS
  The trial, randomised, multi-center, evaluator-blinded, parallel group controlled, is designed according to CONSORT Statement. Eligible subjects are infants born preterm without major complications, aged 3-9 months of corrected age with specific gross-motor abilities defined by Ages & Stages Questionnaire scores. Recruited infants, whose parents will sign a written informed consent for participation, will be randomized in CareToy training and control groups at baseline (T0). CareToy group will perform four weeks of personalized activities with the CareToy system, customized by the rehabilitation staff. The control group will continue standard care. Infant Motor Profile Scale is the primary outcome measure and a total sample size of 40 infants has been established. Bayley-Cognitive subscale, Alberta Infants Motor Scale and Teller Acuity Cards are secondary outcome measures. All measurements will be performed at T0 and at the end of training/control period (T1). For ethical reasons, after this first phase infants enrolled in the control group will perform the CareToy training, while the training group will continue standard care. At the end of open phase (T2) all infants will be assessed as at T1. Further assessment will be performed at 18 months corrected age (T3) to evaluate the long-term effects on neurodevelopmental outcome. Caregivers and rehabilitation staff will not be blinded whereas all the clinical assessments will be performed, videotaped and scored by blind assessors. The trial is ongoing and it is expected to be completed by April 2015.
  
  
  CONCLUSIONS
  This paper describes RCT methodology to evaluate CareToy as a new tool for early intervention in preterm infants, first contribution to test this new type of system. It presents background, hypotheses, outcome measures and trial methodology.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01990183. EU grant ICT-2011.5.1-287932.
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Sgandurra
authors.forename: Laura
authors.initials: L
authors.lastname: Bartalena
authors.affiliation: Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Viale del Tirreno 331, 56128, Calambrone Pisa, Italy. gcioni@fsm.unipi.it.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Cioni
authors.forename: Gorm
authors.initials: G
authors.lastname: Greisen
authors.forename: Anna
authors.initials: A
authors.lastname: Herskind
authors.forename: Emanuela
authors.initials: E
authors.lastname: Inguaggiato
authors.forename: Jakob
authors.initials: J
authors.lastname: Lorentzen
authors.forename: Jens Bo
authors.initials: JB
authors.lastname: Nielsen
authors.forename: Elisa
authors.initials: E
authors.lastname: Sicola
mesh_terms: D003072:Cognition Disorders / Q000517:prevention & control; D003718:Denmark; D002658:Developmental Disabilities / Q000517:prevention & control*; D005246:Feedback; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature; D007558:Italy; D019957:Motor Skills Disorders / Q000517:prevention & control; D009483:Neuropsychological Tests; D010988:Play and Playthings; D017216:Telemedicine; D014159:Transducers