Abstract
BackgroundCongenital brain lesions expose infants to be at high-risk for being affected by neurodevelopmental disorders such as cerebral palsy (CP). Early interventions programs can significantly impact and improve their neurodevelopment. Recently, in the framework of the European CareToy (CT) Project (www.caretoy.eu), a new medical device has been created to deliver an early, intensive, customized, intervention program, carried out at home by parents but remotely managed by expert and trained clinicians. Reviewing results of previous studies on preterm infants without congenital brain lesion, the CT platform has been revised and a new system created (CT-R).This study describes the protocol of a randomised controlled trial (RCT) aimed to evaluate, in a sample of infants at high-risk for CP, the efficacy of CT-R intervention compared to the Infant Massage (IM) intervention.Methods/designThis RCT will be multi-centre, paired and evaluator-blinded. Eligible subjects will be preterm or full-term infants with brain lesions, in first year of age with predefined specific gross motor abilities. Recruited infants will be randomized into CT-R and IM groups at baseline (T0). Based on allocation, infants will perform an 8-week programme of personalized CareToy activities or Infant Massage. The primary outcome measure will be the Infant Motor Profile. On the basis of power calculation, it will require a sample size of 42 infants. Moreover, Peabody Developmental Motor Scales-Second Edition, Teller Acuity Cards, standardized video-recordings of parent-infant interaction and wearable sensors (Actigraphs) will be included as secondary outcome measures. Finally, parents will fill out questionnaires (Bayley Social-Emotional, Parents Stress Index). All outcome measures will be carried out at the beginning (T0) and at end of 8-weeks intervention period, primary endpoint (T1). Primary outcome and some secondary outcomes will be carried out also after 2 months from T1 and at 18 months of age (T2 and T3, respectively). The Bayley Cognitive subscale will be used as additional assessment at T3.DiscussionThis study protocol paper is the first study aimed to test CT-R system in infants at high-risk for CP. This paper will present the scientific background and trial methodology.Trial registrationNCT03211533 and NCT03234959 (www.clinicaltrials.gov).
Highlights
Congenital brain lesions expose infants to be at high-risk for being affected by neurodevelopmental disorders such as cerebral palsy (CP)
A recent systematic review [22] highlighted the effectiveness of IM on promoting neurodevelopment of preterm babies [23]; studies on IM in infants with early brain damage are still limited, it seems to have positive effects on muscle tone and general motor development [24]. Based on this state of the art, the main purpose of this study is to evaluate the effects of CareToy early intervention (EI), compared to those of Infant Massage, on neurodevelopment of infants at high risk for CP
Methods/design This paper presents the protocol of an randomised controlled trial (RCT) which compares the effects of CareToy training to those of Infant Massage on neurodevelopment of infants at high risk for CP
Summary
Congenital brain lesions expose infants to be at high-risk for being affected by neurodevelopmental disorders such as cerebral palsy (CP). Reviewing results of previous studies on preterm infants without congenital brain lesion, the CT platform has been revised and a new system created (CT-R). A recent literature review has shown that brain MRI associated with GMA or neurological examination (Hammersmith Infant Neonatal Examination, HINE) performed at around full-term age determines the greatest predictive power of CP in high-risk newborns [6]. Diagnosis has considerable importance because it allows for an early medical response and intervention which, as indicated by literature, can improve developmental outcome of high-risk children [7]. Early intervention (EI) is crucial because it targets brain plasticity, which for many functions has a maximum expressivity in an early limited time window or “critical period” [8, 9]
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