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

doi:10.1371/journal.pone.0173521

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

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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).

Original language	English
Article number	e0173521
Journal	P L o S One
Volume	12
Issue number	3
Number of pages	13
ISSN	1932-6203
DOIs	https://doi.org/10.1371/journal.pone.0173521
Publication status	Published - Mar 2017

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Sgandurra et al_P L o S One_2017_Vol 12(3)_e0173521Final published version, 783 KBLicence: CC BY

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Sgandurra, G., Lorentzen, J., Inguaggiato, E., Bartalena, L., Beani, E., Cecchi, F., Dario, P., Giampietri, M., Greisen, G., Herskind, A., Nielsen, J. B., Rossi, G., & Cioni, G. (2017). A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'. P L o S One, 12(3), Article e0173521. https://doi.org/10.1371/journal.pone.0173521

Sgandurra, G, Lorentzen, J, Inguaggiato, E, Bartalena, L, Beani, E, Cecchi, F, Dario, P, Giampietri, M, Greisen, G, Herskind, A, Nielsen, JB, Rossi, G & Cioni, G 2017, 'A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'', P L o S One, vol. 12, no. 3, e0173521. https://doi.org/10.1371/journal.pone.0173521

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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).",

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T1 - A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'

AU - Sgandurra, Giuseppina

AU - Lorentzen, Jakob

AU - Inguaggiato, Emanuela

AU - Bartalena, Laura

AU - Beani, Elena

AU - Cecchi, Francesca

AU - Dario, Paolo

AU - Giampietri, Matteo

AU - Greisen, Gorm

AU - Herskind, Anna

AU - Nielsen, Jens Bo

AU - Rossi, Giuseppe

AU - Cioni, Giovanni

N1 - CURIS 2017 NEXS 097

PY - 2017/3

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N2 - 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).

AB - 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).

U2 - 10.1371/journal.pone.0173521

DO - 10.1371/journal.pone.0173521

M3 - Journal article

C2 - 28328946

SN - 1932-6203

VL - 12

JO - P L o S One

JF - P L o S One

IS - 3

M1 - e0173521

ER -

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

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