Cerebral PalsyNCT03211533
Early Identification of Infants at Risk of Cerebral Palsy
An observational study of Cerebral Palsy and Preterm Infant, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
Trial summary
This observational study aims to early identify, through a rigorous and standardized follow-up, infants at high risk for Cerebral Palsy. After the consent agreement firmed by the parents, infants born at term or preterm with ultrasonographic evidence of brain injury considered at risk for neurodevelopmental disorders… Read more about this study
- Who is it for?
- Ages Up to 5 months
- Conditions the study is for
- Cerebral Palsy, Preterm Infant
- How many people
- 99 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jul 2017to 23 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 months
- All sexes
- No healthy volunteers
- Child
Study population: For this observational study will be enrolled infants, born a term or preterm, with very early neurological signs (at term age) and evidences of brain lesion during ultrasound brain screening that are considered at risk for the development of CP.
Who may be able to join
- neurological signs (Hammersmith Infant Neurological Examination/General Movement Assessment according Precthl's).
- signs of brain injury identified at ultrasound brain exam
Who cannot join
- brain malformations
- severe sensory deficits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CareToy Observational Study: Early Identification of Infants at Risk of Cerebral Palsy
This observational study aims to early identify, through a rigorous and standardized follow-up, infants at high risk for Cerebral Palsy. After the consent agreement firmed by the parents, infants born at term or preterm with ultrasonographic evidence of brain injury considered at risk for neurodevelopmental disorders will be strictly monitored during the first months of life performing a periodic neurological assessment (Prechtl's General Movement (GMA) and the Hammersmith Infant Neurological Examination) at term age and around 3 months of post term age. Moreover, to study more accurately the brain injury early identified by ultrasonographic brain exam, around 6 weeks of post-term age the enrolled infants will perform, as recommended in infants at risk, brain Magnetic Resonance (RM).
Thanks to the high predictability power of the combination of the clinical observation with the neuroimaging infants at high risk of CP will be early detect. Selected infants, considered at high risk for CP will have the opportunity to perform an home based and family centered early intervention later than 3 post term age.
Read the detailed description
Scientific literature review shows evidence that early intervention, especially when performed in the first months of life, when the brain plasticity shows its great expressivity, has positive effects on neurodevelopmental outcomes. In this framework the early identification of infants at risk for neurodevelopmental disorders is a major prerequisite to start very early an intervention programme. To families of infants, born in Neonatal Units involved in this study, will be asked with written informed consent, to participate in this observational study that aims to early identify, through a rigorous and standardized follow-up, infants at high risk for CP. Infants born at term or preterm with ultrasonographic evidence of brain injury considered at risk for neurodevelopmental disorders will be strictly monitored during the first months of development by the clinical team (Child Neurologists and Neonatologists) performing a periodic neurological assessment through examination of the Prechtl's General Movement (GMA) and the Hammersmith Infant Neurological Examination, at term age and around 3 months of post term age. Moreover, to study more accurately the brain injury early identified by ultrasonographic brain exam, within 6 weeks post-term age enrolled infants will perform, as recommended in infants at risk, brain Magnetic Resonance (RM). During the conventional RM examination, when possible, a fMRI perceptive task will be also performed to evaluate possible predictor factors to the responsiveness to the early intervention.
Thanks to the high predictability power of the combination of the clinical observation with the neuroimaging infants at high risk of CP will be early detect. Selected infants, considered at high risk for CP will have the opportunity to perform an home based and family centered early intervention later than 3 post term age.
- Conditions
- Cerebral Palsy, Preterm Infant
- Keywords
- infants at risk of cerebral palsy, MRI, general movements
- Medical subject headings
- Cerebral Palsy, Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Fidgety Movements at 12 weeks (post-term age)
The Prechtl's General Movements Assessment is a non-invasive and cost-effective way to identify neurological issues which may lead to cerebral palsy and other developmental disabilities. The Fidgety movements are usually assessed between 9-20 weeks post-term age, showing the best expression at 12 weeks post term age. Infants whose Fidgety movements are absent or abnormal are at higher risk of neurological conditions, in particular for cerebral palsy.
Measured: 12 weeks post-term age
Secondary outcomes (2)
Writhing Movements at 40 weeks (term age)
The 'writhing movements' (described in the Prechtl's General Movements Assessment) are present from term age until 8 weeks post-term age. The evaluation at 40 weeks is a key point for the assessment both in preterm and at term infants. Infants whose writhing movements are abnormal could be considered at risk for neurodevelopmental disabilities; they have been carefully monitored in the fidgety period (see primary outcome measure).
Measured: 40 weeks (term age)
Magnetic resonance imaging rating scale
Infants recruited will perform, according to gold standard clinical guidelines, a MRI study of the brain lesion previously identified with brain ultrasound. MRI will allow to better study the type of lesion. It will be quantified according to a validated visual semi-quantitative rating scale that uses a reliable and valid anatomical template for a graphical representation of abnormal MRI findings with detailed scoring of relative brain structures. During the MRI a task of fMRI will be performed to identify predictors of response to treatment.
Measured: up to 6 weeks (post-term age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start22 Jul 2017
- Primary completion1 Jun 2020
- Study completion23 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211533
- Sponsor's protocol ID
- RF-2013-02358095
- Status last verified
- Oct 2019
- First submitted
- 28 Jun 2017
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beani E, Rizzi R, Barzacchi V, Menici V, Fioroni Ribeiro da Silva C, Martini G, Sicola E, Dani C, Cecchi A, Cioni ML, Paternoster F, Fiorini P, Di Galante M, Faraguna U, Dario P, Cecchi F, Mannari I, Maselli M, Giampietri M, Ghirri P, Dubbini N, Cioni G, Sgandurra G. Home based early intervention with CareToy-Revised in infants with early brain injury: a randomized controlled trial. Front Med (Lausanne). 2026 Aug 12;13:1830574. doi: 10.3389/fmed.2026.1830574. eCollection 2026.
PubMed 42656486Franchi De' Cavalieri M, Filogna S, Martini G, Beani E, Maselli M, Cianchetti M, Dubbini N, Cioni G, Sgandurra G; CareToy-R Consortium. Wearable accelerometers for measuring and monitoring the motor behaviour of infants with brain damage during CareToy-Revised training. J Neuroeng Rehabil. 2023 May 6;20(1):62. doi: 10.1186/s12984-023-01182-z.
PubMed 37149595Menici V, Antonelli C, Beani E, Mattiola A, Giampietri M, Martini G, Rizzi R, Cecchi A, Cioni ML, Cioni G, Sgandurra G; Caretoy-R Consortium. Feasibility of Early Intervention Through Home-Based and Parent-Delivered Infant Massage in Infants at High Risk for Cerebral Palsy. Front Pediatr. 2021 Jul 19;9:673956. doi: 10.3389/fped.2021.673956. eCollection 2021.
PubMed 34350144Sgandurra G, Beani E, Giampietri M, Rizzi R, Cioni G; CareToy-R Consortium. Early intervention at home in infants with congenital brain lesion with CareToy revised: a RCT protocol. BMC Pediatr. 2018 Sep 5;18(1):295. doi: 10.1186/s12887-018-1264-y.
PubMed 30185165
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CareToy Observational Study: Early Identification of Infants at Risk of Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03211533
- Acronym / sponsor ID
- RF-2013-02358095
- Conditions
- Cerebral Palsy, Preterm Infant
- Keywords
- infants at risk of cerebral palsy, MRI, general movements
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Study start
- 22 Jul 2017 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study aims to early identify, through a rigorous and standardized follow-up, infants at high risk for Cerebral Palsy. After the consent agreement firmed by the parents, infants born at term or preterm with ultrasonographic evidence of brain injury considered at risk for neurodevelopmental disorders will be strictly monitored during the first months of life performing a periodic neurological assessment (Prechtl's General Movement (GMA) and the Hammersmith Infant Neurological Examination) at term age and around 3 months of post term age. Moreover, to study more accurately the brain injury early identified by ultrasonographic brain exam, around 6 weeks of post-term age the enrolled infants will perform, as recommended in infants at risk, brain Magnetic Resonance (RM).
Thanks to the high predictability power of the combination of the clinical observation with the neuroimaging infants at high risk of CP will be early detect. Selected infants, considered at high risk for CP will have the opportunity to perform an home based and family centered early intervention later than 3 post term age.
Detailed description
Scientific literature review shows evidence that early intervention, especially when performed in the first months of life, when the brain plasticity shows its great expressivity, has positive effects on neurodevelopmental outcomes. In this framework the early identification of infants at risk for neurodevelopmental disorders is a major prerequisite to start very early an intervention programme. To families of infants, born in Neonatal Units involved in this study, will be asked with written informed consent, to participate in this observational study that aims to early identify, through a rigorous and standardized follow-up, infants at high risk for CP. Infants born at term or preterm with ultrasonographic evidence of brain injury considered at risk for neurodevelopmental disorders will be strictly monitored during the first months of development by the clinical team (Child Neurologists and Neonatologists) performing a periodic neurological assessment through examination of the Prechtl's General Movement (GMA) and the Hammersmith Infant Neurological Examination, at term age and around 3 months of post term age. Moreover, to study more accurately the brain injury early identified by ultrasonographic brain exam, within 6 weeks post-term age enrolled infants will perform, as recommended in infants at risk, brain Magnetic Resonance (RM). During the conventional RM examination, when possible, a fMRI perceptive task will be also performed to evaluate possible predictor factors to the responsiveness to the early intervention.
Thanks to the high predictability power of the combination of the clinical observation with the neuroimaging infants at high risk of CP will be early detect. Selected infants, considered at high risk for CP will have the opportunity to perform an home based and family centered early intervention later than 3 post term age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- For this observational study will be enrolled infants, born a term or preterm, with very early neurological signs (at term age) and evidences of brain lesion during ultrasound brain screening that are considered at risk for the development of CP.
Key inclusion criteria (2 listed)
- neurological signs (Hammersmith Infant Neurological Examination/General Movement Assessment according Precthl's).
- signs of brain injury identified at ultrasound brain exam
Key exclusion criteria (2 listed)
- brain malformations
- severe sensory deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fidgety Movements at 12 weeks (post-term age)
Time frame: 12 weeks post-term age
The Prechtl's General Movements Assessment is a non-invasive and cost-effective way to identify neurological issues which may lead to cerebral palsy and other developmental disabilities. The Fidgety movements are usually assessed between 9-20 weeks post-term age, showing the best expression at 12 weeks post term age. Infants whose Fidgety movements are absent or abnormal are at higher risk of neurological conditions, in particular for cerebral palsy.
2 secondary outcomes
Writhing Movements at 40 weeks (term age)
Time frame: 40 weeks (term age)
Magnetic resonance imaging rating scale
Time frame: up to 6 weeks (post-term age)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Derived from this study: PubMed 42656486Beani E, Rizzi R, Barzacchi V, Menici V, Fioroni Ribeiro da Silva C, Martini G, Sicola E, Dani C, Cecchi A, Cioni ML, Paternoster F, Fiorini P, Di Galante M, Faraguna U, Dario P, Cecchi F, Mannari I, Maselli M, Giampietri M, Ghirri P, Dubbini N, Cioni G, Sgandurra G. Home based early intervention with CareToy-Revised in infants with early brain injury: a randomized controlled trial. Front Med (Lausanne). 2026 Aug 12;13:1830574. doi: 10.3389/fmed.2026.1830574. eCollection 2026.
- Derived from this study: PubMed 37149595Franchi De' Cavalieri M, Filogna S, Martini G, Beani E, Maselli M, Cianchetti M, Dubbini N, Cioni G, Sgandurra G; CareToy-R Consortium. Wearable accelerometers for measuring and monitoring the motor behaviour of infants with brain damage during CareToy-Revised training. J Neuroeng Rehabil. 2023 May 6;20(1):62. doi: 10.1186/s12984-023-01182-z.
- Derived from this study: PubMed 34350144Menici V, Antonelli C, Beani E, Mattiola A, Giampietri M, Martini G, Rizzi R, Cecchi A, Cioni ML, Cioni G, Sgandurra G; Caretoy-R Consortium. Feasibility of Early Intervention Through Home-Based and Parent-Delivered Infant Massage in Infants at High Risk for Cerebral Palsy. Front Pediatr. 2021 Jul 19;9:673956. doi: 10.3389/fped.2021.673956. eCollection 2021.
- Derived from this study: PubMed 30185165Sgandurra G, Beani E, Giampietri M, Rizzi R, Cioni G; CareToy-R Consortium. Early intervention at home in infants with congenital brain lesion with CareToy revised: a RCT protocol. BMC Pediatr. 2018 Sep 5;18(1):295. doi: 10.1186/s12887-018-1264-y.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Preterm Infant, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidgety Movements at 12 weeks (post-term age) (time frame: 12 weeks post-term age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03211533, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.