Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05123768 |
| Other study ID # |
0120-142/2021/2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
November 1, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
University Medical Centre Ljubljana |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Cerebral palsy (CP) is a permanent disorder of movement or posture due to non-progressive
impairments of the developing brain. Current estimates indicate that as many as 30% of CP
cases may be genetic in nature. In our study, the investigators will re-examine the data of
children with CP, who are registered in the Slovenian National Registry of Cerebral Palsy.
All children will be invited to the University Children's Hospital, University Medical Centre
Ljubljana, where they will be re-examined by a neurologist. Blood for genetic testing will be
taken. In the case of confirmed genetic ethiology of CP, the search for specific therapy will
be possible.
Description:
Cerebral palsy (CP) is a permanent disorder of movement or posture due to non-progressive
impairments of the developing brain. In children, CP is the most common cause of motor
impairment, which is often accompanied by other disorders such as epilepsy, mental
retardation, speech and language disorders, eating disorders, visual and hearing disorders,
and behavioral disorders. Approximately 1 child in every 500 live births is diagnosed with
cerebral palsy.
The causes of CP are usually related to inadequate blood flow and oxygen supply to the baby's
central nervous system during pregnancy or birth, complications of premature birth, and other
complications in the neonatal period such as respiratory distress, infections, or jaundice.
It is estimated that in up to one third of children with CP the cause is unexplained. The
cause of CP in these children may also be rare genetic diseases. For some of these diseases a
targeted treatment is available.
In Slovenia, all children with CP, born since 1996, are included in the Slovenian National
Registry of Cerebral Palsy (SRCP), which is part of the European registry - Surveillance of
Cerebral Palsy in Europe (SCPE). Children are entered into the register at University
Children's Hospital, University Medical Centre Ljubljana at the age of 5, after prior
parental consent, otherwise anonymously.
In our study, the investigators will re-examine the data of children with CP, who are
registered in the SRCP. All children will be invited to the University Children's Hospital,
University Medical Centre Ljubljana, where they will be re-examined by a neurologist. With
the consent of the patient or his/her parent/guardian, blood for genetic test will be taken.
Utilising next gen sequencing (NGS), a gene panel of more than 100 genes associated with the
CP spectrum disorders will be performed. In the case of confirmed genetic ethiology of CP,
the search for specific therapy will be possible.
