Please select the eligibility criteria that correspond to the clinical trial below.
Title: CareToy - A Modular Smart System for Infants' Rehabilitation at Home Based on Mechatronic Toys
Brief Summary: Stroke and other neurological conditions affect the population of infants in percentages that cannot be considered marginal. Preterm infants are the highest infants at risk for neurological damage. Currently, infants have rehabilitation sessions few times a week in rehabilitation centres but according to basic neuroscience it would be necessary to provide them with an early, intensive and multiaxial intervention. One option to reduce the cost of the entire European Healthcare System while increasing the practice of rehabilitation is to devise therapies and technologies that can be administered at home by caregivers and telemonitored by rehabilitation staff. The aim of this proposal is to promote early intervention in the first year of life and to reinforce therapy by "CareToy": a portable low cost smart system telemonitored thus augmenting the clinical effectiveness of the therapy while reducing the cost. The smart system is based on a common baby gym, composed of different modules: a) an instrumented baby gym with mechatronic hanging toys, so that the infants' actions on the gym can be measured and stimulated, b) a vision module, for measuring and promoting infants' attention and gaze movements and c) a sensorized mat for measuring and promoting postural control. Each module will also incorporate built-in signal processor, memory and wireless communication. A fourth telerehabilitation module completes the system that allows the system to remotely communicate with the rehabilitation staff for monitoring and assessing the rehabilitation techniques. CareToy and the effectiveness of home rehabilitation based on this system will be validated by clinical trials on at least 50 preterm infants. The result of this project could have a large impact. CareToy may become a commercial product, manufactured on a large scale and distributed not only in rehabilitation centres but also at homes, sold or rented by the Health Care System to families as a therapeutic tool for care intensity.


Options:
A: Inclusion Criteria (infants):

* born below 35 weeks gestational age
* determined by medical staff to have achieved sufficient medical stability to start MT
* likely to be hospitalized longer than 2 weeks from time of recruitment

Inclusion Criteria (parents):

* willing to engage in at least 2 of 3 MT sessions per week during NICU and/or in 5 of 7 MT post-discharge sessions, if randomized to receive MT
* live with reasonable commuting distance from the treating NICU
* sufficient understanding of the respective national language(s) to answer questionnaires and participate in MT

Exclusion Criteria (parents):

* documented mental illness or cognitive impairment that prevents them from being able to complete the study intervention or outcome assessments
B: Inclusion Criteria:

* Infant is born a singleton or twin in the Morgan Stanley Children's Hospital in New York City
* Infant is born 26 and 34 weeks post-conceptional age (PCA)

Exclusion Criteria:

* Mothers cannot understand or speak English
* Mother has history of drug addiction, psychosis or other severe mental illness
* There is not at least one adult other than the mother in the home
* Infant birth weight is below the third percentile for gestational age
* Infant has significant congenital defects
C: Inclusion Criteria:

* Birth weight \< 2000 gram

Exclusion Criteria:

* Congenital anomalies
* Non-Norwegian speaking mother
* Triplets
D: Inclusion Criteria:

* gestational age ≥ 28+0 weeks and 32+6 weeks
* corrected age at baseline: between 3 and 9 months;
* achievement of predefined cut off scores in gross motor ability derived from Ages \& Stages Questionnaire® Third Edition (ASQ-3), in relation to corrected age (Bricker and Squires, 1999)

In detail:

* 4 months form (from 3 months to 4 months 30 days) score ≥ 10;
* 6 months form (from 5 months to 6 months 30 days) score ≥ 5 - \< 50;
* 8 months form (from 7 months to 8 months 30 days) ≥ 10 - \<30

Exclusion Criteria:

* infants with gestational age \< 28 weeks or ≥ 33 weeks
* infants small for gestational age (i.e. weight below the 10th, ref)
* presence of brain damage (i.e. brain malformation, intra-ventricular haemorrhage \[IVH\] \>1 ; any degree of periventricular leukomalacia (ref)
* known epilepsy or other form of seizure
* severe sensory deficits (blindness, deafness)
* other severe non neurological malformations
* participation in other experimental studies having rehabilitation aims

Answer: D