Early intervention at home in infants with congenital brain lesion with CareToy revised: a RCT protocol

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).

Concurrent and Predictive Validity of the Infant Motor Profile in Infants at Risk of Neurodevelopmental Disorders

“…Infants were retrospectively recruited among the participants of two clinical trials during which an 8-weeks intervention program based on infant massage or telerehabilitation was provided; a mild effect of these programs on the final outcome cannot be ruled out. 25 , 26 Furthermore, we provided a coarse classification of brain imaging since no widely used classification system of perinatal brain 12 injury takes into account both term and preterm patterns of injury. Our classification might not accurately reflect the actual severity of some pattern of brain injury.…”

Feasibility Analysis of CareToy-Revised Early Intervention in Infants at High Risk for Cerebral Palsy

“…The study protocol of the RCT project and the detailed description of the system have been published elsewhere ( 12 ). The wide CareToy-R RCT study is a multi-center, paired, and evaluator-blinded study with two investigative arms of two EI: Infant Massage and CareToy-R training for a duration of 8 weeks, in which eligible infants are allocated randomly at baseline (T0).…”

“…After the enrolment, infants were allocated to one of the two investigative arms: CareToy-R training or Infant Massage [for details see Sgandurra et al ( 12 )]. Both interventions lasted 8 weeks and during this phase infants continue to receive standard care provided by National Health System.…”

“…Assessments, already described in the study protocol ( 12 ), were performed by a child neurologist and a therapist at the following times:…”

“…Basing on this experience, an EI program using a revised version of CareToy system (CareToy-Revised, CT-R) has been implemented in an ongoing RCT involving high-risk infants with perinatal brain injury (Trial registration: NCT03211533 and NCT03234959) ( 12 ).…”