Please select the eligibility criteria that correspond to the clinical trial below.
Title: CareToy: a Smart System for Early Home-based Intervention in Infants at High Risk for Cerebral Palsy
Brief Summary: Cerebral Palsy (CP), due to pre-perinatal brain lesions, is a main cause of childhood disabilities with high cost for individuals and society. Early Intervention (EI), if intensive enough but affordable by patients, family and health services can improve its outcome. A recent Cochrane review indicates the positive effects of Infant Massage (IM) in gross and fine motor skills, visual development and parent infants interaction in preterm infants. Recently, a new technological tool, called CareToy has been developed as a tele-rehabilitation tool for delivering at home EI. The effects of CT training on neurodevelopmental outcome have been recently tested in a sample of low-risk preterm infants with very promising results. The aim of the project is to provide evidence, by a RCT, of the efficacy of CareToy (CT) training versus Infant Massage, in a sample of 45 infants aged 3-12 months (or with motor competencies from initial head control to unstable sitting position) at high risk for CP according to strict clinical and neuroradiological signs. Enrolled infants will be randomized in 2 groups: CareToy and Infant Massage. Infants allocated in CT group will perform a training with CT while the others will perform infant massage. Both trainings will be carried out at home by parents with the monitoring of the therapists. Both interventions will last 8 weeks. All enrolled infants will be evaluated at baseline (T0),9 wks after the CT/IM (T1), 9 wks after T1 (T2) and at 18 months of post term age (T3). Infant Motor Profile will be the primary outcome measure.


Options:
A: Inclusion Criteria:

* Preterm infants born in our institution will be included when they complete 48 hours after birth

Exclusion Criteria:

* Congenital malformations
B: Inclusion Criteria for preterm infants:

* BW below 1,501 gm
* GA under 37 weeks
* Admission to the NICU within the first 7 days of life
* Physiologically stable at PCA 36 weeks as diagnosed by attending physician
* Hospital discharge prior to PCA 40 weeks
* Absence of congenital anomalies and/or severe neonatal diseases
* Family residence in the greater Taipei area.

Exclusion Criteria for preterm infants:

* Severe neonatal diseases included major neurologic abnormalities (such as seizures, hydrocephalus, ventriculoperitoneal shunt, meningitis, periventricular leukomalacia, grade III-IV intraventricular hemorrhage, and grade IV retinopathy of prematurity)
* Necrotizing enterocolitis with colostomy
* Severe cardiopulmonary disease requiring daily oxygen use at hospital discharge

Inclusion Criteria for full-term infants:

* Birth weight \>2,500 g;
* Gestational age within 38-42 weeks,
* Family living in the same geographic region as those of the VLBW preterm infants

Exclusion Criteria for full-term infants:

* Serious prenatal or perinatal complications
C: Inclusion Criteria:

* All infants born very preterm (˂29 weeks of gestation) and cared for in the Neonatal Intensive Care Unit at the Children's Hospital of Richmond (CHoR) at Virginia Commonwealth University (VCU) or University of Virginia Hospital (UVa) will be offered an enrollment if they meet the following inclusion criteria.

  1. Infants must be medically stable, off ventilator support by 42 weeks of gestation
  2. live within 60 miles of either hospital (which are 75 miles apart). Early Intervention services in Virginia.
* A parent or LRA will also be enrolled in the study. Inclusion criteria for the adult is that they speak English and will be a caregiver for the enrolled infant.

Exclusion Criteria:

* Exclusion criteria include diagnosis of a genetic syndrome or unstable medical condition beyond 42 weeks of gestation.
D: Inclusion Criteria:

* i) abnormal neurological signs (i.e. neurological signs at the Hammersmith Infant Neurological Assessment -HINE- and according to Prechtl's Assessment GMA) at 2-4 mts post term age
* ii) neuroimaging evidence of brain lesion indicated by MRI performed around the term age (4-6 wks post term)
* iii) achieved predefined motor development scores assessed by Ages and Stages Questionnaire-3
* iv) informed consent agreement

Exclusion Criteria:

* i) Drug resistant seizures,
* ii) Severe sensory deficits (blindness or deafness)
* iii) Progressive neurological disorders
* iv) Malformation of CNS

Answer: D