A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'.
CareToy system is an innovative tele-rehabilitative tool, useful in providing intensive, individualized, home-based, family-centred Early Intervention (EI) in infants. Our aim was to evaluate, through a Randomized Clinical Trial (RCT) study, the effects of CareToy intervention on early motor and visual development in preterm infants. 41 preterm infants (range age: 3.0-5.9 months of corrected age) were enrolled and randomized into two groups, CareToy and Standard Care. 19 infants randomized in CareToy group performed a 4-week CareToy program, while 22 allocated to control group completed 4 weeks of Standard Care. Infant Motor Profile (IMP) was primary outcome measure, Alberta Infant Motor Scale (AIMS) and Teller Acuity Cards were secondary ones. Assessments were carried out at baseline (T0) and at the end of CareToy training or Standard Care period (T1). T1 was the primary endpoint. After RCT phase, 17 infants from control group carried out a 4-week CareToy program, while 18 infants from the CareToy group continued with Standard Care. At the end of this phase, infants were re-assessed at T2. In RCT phase, delta IMP total score and variation and performance sub-domains were significantly higher (P<0.050) in CareToy group if compared to Standard Care group. Similar results were found for Teller Acuity Cards, while no differences between groups were found for AIMS. No differences were found in any outcome measure results (T2-T0), between infants who started CareToy training before or after one month of standard care. This RCT study confirms the results of a previous pilot study, indicating that CareToy system can provide effective home-based EI.


BACKGROUND
This trial has been registered at www.clinicaltrials.gov (Identifier NCT01990183).
Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Calambrone, Pisa, Italy.|Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Giuseppina
G
Sgandurra
Helene Elsass Center, Charlottenlund, Denmark.|Department of Nutrition, Exercise and Sport, University of Copenhagen, Copenhagen, Denmark.
Jakob
J
Lorentzen
Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Calambrone, Pisa, Italy.|Scuola Superiore Sant'Anna, Institute of Life of Sciences, Pisa, Italy.
Emanuela
E
Inguaggiato
Neonatal Intensive Care Unit, Pisa University Hospital Santa Chiara, Pisa, Italy.
Laura
L
Bartalena
Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Calambrone, Pisa, Italy.
Elena
E
Beani
The BioRobotics Institute, Polo Sant'Anna Valdera, Pontedera, Pisa, Italy.
Francesca
F
Cecchi
The BioRobotics Institute, Polo Sant'Anna Valdera, Pontedera, Pisa, Italy.
Paolo
P
Dario
Neonatal Intensive Care Unit, Pisa University Hospital Santa Chiara, Pisa, Italy.
Matteo
M
Giampietri
Department of Neonatology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.
Gorm
G
Greisen
Helene Elsass Center, Charlottenlund, Denmark.|Department of Neonatology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.|Department of Neuroscience and Pharmacology, University of Copenhagen, Copenhagen, Denmark.
Anna
A
Herskind
Department of Nutrition, Exercise and Sport, University of Copenhagen, Copenhagen, Denmark.|Department of Neuroscience and Pharmacology, University of Copenhagen, Copenhagen, Denmark.
Jens Bo
JB
Nielsen
Unit of Epidemiology and Biostatistics, Institute of Clinical Physiology, CNR, Pisa, Italy.
Giuseppe
G
Rossi
Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Calambrone, Pisa, Italy.|Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Giovanni
G
Cioni
D002657:Child Development; D002658:Developmental Disabilities / Q000503:physiopathology / Q000534:rehabilitation*; D018479:Early Intervention, Educational / Q000379:methods*; D005260:Female; D006699:Home Care Services; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D009048:Motor Skills; D017063:Outcome Assessment, Health Care; D010988:Play and Playthings; D011597:Psychomotor Performance; D000069350:Telerehabilitation / Q000295:instrumentation / Q000379:methods*