Evidence map›Paper›PMID 28328946›Full record

Trial reportPloS one2017

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 and 4 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01990183 (CareToy - A Modular Smart System for Infants' Rehabilitation at Home Based on Mechatronic Toys), which is not on this map. Cited by 38 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01990183 nacompletednot on this map

CareToy - A Modular Smart System for Infants' Rehabilitation at Home Based on Mechatronic Toys

TypeinterventionalSponsorIRCCS Fondazione Stella MarisRan2013 to 2015Enrolled44ConditionsPreterms at Risk for Developmental DisordersArmsCareToy, Standard Care
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  11. Article
  12. A Systematic Review of Neurodevelopmental Tools for Preterm Infants During Infancy: Mapping the Components Across Infant Age Quarters.Indian journal of community medicine : official publication of Indian Association of Preventive & Social Medicine · 2025
    Review
  13. Review
  14. Article
  15. Article
  16. The Homeostasis-Enrichment-Plasticity (HEPJournal of clinical medicine · 2024
    Article
  17. HEPChildren (Basel, Switzerland) · 2024
    Article
  18. Article
  19. Motor Development Comparison between Preterm and Full-Term Infants Using Alberta Infant Motor Scale.International journal of environmental research and public health · 2023
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Giuseppina SgandurraDepartment of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Calambrone, Pisa, Italy.
Jakob LorentzenHelene Elsass Center, Charlottenlund, Denmark.
Emanuela InguaggiatoDepartment of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Calambrone, Pisa, Italy.
Laura BartalenaNeonatal Intensive Care Unit, Pisa University Hospital Santa Chiara, Pisa, Italy.
Elena BeaniDepartment of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Calambrone, Pisa, Italy.
Francesca CecchiThe BioRobotics Institute, Polo Sant'Anna Valdera, Pontedera, Pisa, Italy.
Paolo DarioThe BioRobotics Institute, Polo Sant'Anna Valdera, Pontedera, Pisa, Italy.
Matteo GiampietriNeonatal Intensive Care Unit, Pisa University Hospital Santa Chiara, Pisa, Italy.
Gorm GreisenDepartment of Neonatology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark.
Anna HerskindHelene Elsass Center, Charlottenlund, Denmark.
Jens Bo NielsenDepartment of Nutrition, Exercise and Sport, University of Copenhagen, Copenhagen, Denmark.
Giuseppe RossiUnit of Epidemiology and Biostatistics, Institute of Clinical Physiology, CNR, Pisa, Italy.
Giovanni CioniDepartment of Developmental Neuroscience, IRCCS Fondazione Stella Maris, Calambrone, Pisa, Italy.
CareToy Consortium

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 registrationThis trial has been registered at www.clinicaltrials.gov (Identifier NCT01990183).

Indexed as

Home Care ServicesInfant, PrematurePlay and PlaythingsChild DevelopmentDevelopmental DisabilitiesEarly Intervention, EducationalFemaleHumansInfantInfant, NewbornMaleMotor SkillsOutcome Assessment, Health CarePsychomotor PerformanceTelerehabilitation

Identifiers

PMID28328946
PMCPMC5362053

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.