A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'

Giuseppina Sgandurra, Jakob Lorentzen, Emanuela Inguaggiato, Laura Bartalena, Elena Beani, Francesca Cecchi, Paolo Dario, Matteo Giampietri, Gorm Greisen, Anna Herskind, Jens Bo Nielsen, Giuseppe Rossi, Giovanni Cioni, CareToy Consortium, Giuseppina Sgandurra, Jakob Lorentzen, Emanuela Inguaggiato, Laura Bartalena, Elena Beani, Francesca Cecchi, Paolo Dario, Matteo Giampietri, Gorm Greisen, Anna Herskind, Jens Bo Nielsen, Giuseppe Rossi, Giovanni Cioni, CareToy Consortium

Abstract

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.

Trial registration: This trial has been registered at www.clinicaltrials.gov (Identifier NCT01990183).

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1. Flow-chart of study according to…
Fig 1. Flow-chart of study according to CONSORT diagram.
Fig 2. Regression analysis.
Fig 2. Regression analysis.
Legend. Scatter plot of delta changes after CareToy training in Infant Motor Profile (A) and in Teller Acuity Cards versus number of hours of performed CareToy training. Solide lines represent the linear fit of data. Dotted lines represent Confidence Interval at 95%.

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Source: PubMed

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