Cerebral PalsyMILPCI2024NCT07916519
Early Detection of Cerebral Palsy Subtype
An observational study of Cerebral Palsy and Early Assessment, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Early identification of cerebral palsy (CP) has improved with the combined use of the General Movements Assessment (GMA), the Hammersmith Infant Neurological Examination (HINE) and magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 3 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Early Assessment, Early Rehabilitation Intervention
- What is being tested?
- Neurofunctional assessment for early identification of cerebral palsy motor subtypes and functional prognosis
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2026to 10 Sep 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: cerebral palsy or infants at neurological risk
Who may be able to join
- premature and/or children at high neurological risk;
- age between 0 and 3 months of corrected age;
- Abnormal GMs and/or pathological MRI and/or abnormal HINE neurological examination;
- signing of informed consent by parents or legal guardian.
Who cannot join
- congenital malformations;
- genetic syndromes;
- metabolic diseases;
- absence of written consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
About this study
Official title: Early Detection of Cerebral Palsy Subtype and Functional Prognosis Using the Neurofunctional Assessment in High-Risk Infants: Protocol of a Prospective Observational Diagnostic Accuracy Study
Early identification of cerebral palsy (CP) has improved with the combined use of the General Movements Assessment (GMA), the Hammersmith Infant Neurological Examination (HINE) and magnetic resonance imaging (MRI). Emerging evidence indicates that the incorporation of additional instruments, may further enhance specificity and facilitate comorbidity identification. However, predicting motor subtype and functional prognosis in infancy remains difficult. The Neurofunctional Assessment (NFA) is a global tool, originally developed for preterm infants, that focuses on the development of normal functions and is based on the International Classification of Functioning, Disability and Health (ICF) approach. This study focuses on seven postural-motor manoeuvres drawn from the full NFA (squatting, balancing, supine-to-sit righting, ventral suspension, axillary suspension, lateral suspension and guided rolling), which assess three domains: axial control, distal selective motor control and lateral asymmetries.
- Being tested
- Neurofunctional assessment for early identification of cerebral palsy motor subtypes and functional prognosis
- Keywords
- Cerebral Palsy, Motor subtype, functional prognosis, Neurofunctional assessment
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofunctional assessment for early identification of cerebral palsy motor subtypes and functional prognosisOther
To determine whether domain-specific findings from the seven-manoeuvre NFA battery support earlier and more precise characterisation of CP motor subtype and functional prognosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
gmfm
The Gross Motor Function Measure (GMFM-88) is a standardized observational instrument designed and validated to measure changes in gross motor function over time in children with cerebral palsy (CP)
Measured: every 6 months up to 2 years
GMDS
Griffiths Scales of Child Development (Third Edition, or Griffiths III) is a standardized, play-based assessment tool used to measure a child's overall development and create a detailed profile of strengths and needs from birth to 5 years and 11 months of age.
Measured: 2 years
Secondary outcomes (1)
gmds
The GMDS (Griffiths Mental Development Scales) is one of the most widely used and internationally recognized standardized instruments for assessing global development in infants, toddlers, and young children. Originally designed by psychologist Ruth Griffiths, the scales are used to detect developmental delays, track clinical progress, and construct a comprehensive profile of a child's developmental strengths and difficulties.
Measured: at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start10 Mar 2026
- Primary completion10 Sep 2026
- Study completion10 Sep 2028 (estimated)
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.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Porro, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916519
- Sponsor's protocol ID
- 6850
- Acronym
- MILPCI2024
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Novak I, Morgan C, Adde L, Blackman J, Boyd RN, Brunstrom-Hernandez J, Cioni G, Damiano D, Darrah J, Eliasson AC, de Vries LS, Einspieler C, Fahey M, Fehlings D, Ferriero DM, Fetters L, Fiori S, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Kakooza-Mwesige A, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Maitre N, McIntyre S, Noritz G, Pennington L, Romeo DM, Shepherd R, Spittle AJ, Thornton M, Valentine J, Walker K, White R, Badawi N. Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA Pediatr. 2017 Sep 1;171(9):897-907. doi: 10.1001/jamapediatrics.2017.1689.
PubMed 28715518Hadders-Algra M, Tacke U, Pietz J, Philippi H. Cerebral palsy: an update on its early detection. Lancet. 2026 Dec 20;406(10522):2921-2922. doi: 10.1016/S0140-6736(25)02310-4. No abstract available.
PubMed 41421834Peyton C, Aaby D, Barbosa VM, Boswell L, de Regnier RA, Bos AF, Sukal Moulton T. Baby Observational Selective Control AppRaisal (BabyOSCAR): Scores at 3 months predict functional ability, spastic cerebral palsy distribution, and diagnosis at 2 years. Dev Med Child Neurol. 2024 Nov;66(11):1521-1528. doi: 10.1111/dmcn.15925. Epub 2024 Apr 17.
PubMed 38629475Picciolini O, Gianni ML, Messina L, Pesenti N, Fumagalli M, Gardon L, Squarza C, Mosca F, Fontana C, Porro M. Development of a new scoring method in the neurofunctional assessment of preterm infants. Sci Rep. 2022 Sep 29;12(1):16335. doi: 10.1038/s41598-022-20754-y.
PubMed 36175601
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Cerebral Palsy Subtype and Functional Prognosis Using the Neurofunctional Assessment in High-Risk Infants: Protocol of a Prospective Observational Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT07916519
- Acronym / sponsor ID
- MILPCI2024 / 6850
- Keywords
- Cerebral Palsy, Motor subtype, functional prognosis, Neurofunctional assessment
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 10 Sep 2026 (actual)
- Study completion
- 10 Sep 2028 (estimated)
- First posted
- 4 Nov 2026 (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.
Early identification of cerebral palsy (CP) has improved with the combined use of the General Movements Assessment (GMA), the Hammersmith Infant Neurological Examination (HINE) and magnetic resonance imaging (MRI). Emerging evidence indicates that the incorporation of additional instruments, may further enhance specificity and facilitate comorbidity identification. However, predicting motor subtype and functional prognosis in infancy remains difficult. The Neurofunctional Assessment (NFA) is a global tool, originally developed for preterm infants, that focuses on the development of normal functions and is based on the International Classification of Functioning, Disability and Health (ICF) approach. This study focuses on seven postural-motor manoeuvres drawn from the full NFA (squatting, balancing, supine-to-sit righting, ventral suspension, axillary suspension, lateral suspension and guided rolling), which assess three domains: axial control, distal selective motor control and lateral asymmetries.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 3 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- cerebral palsy or infants at neurological risk
Key inclusion criteria (4 listed)
- premature and/or children at high neurological risk;
- age between 0 and 3 months of corrected age;
- Abnormal GMs and/or pathological MRI and/or abnormal HINE neurological examination;
- signing of informed consent by parents or legal guardian.
Key exclusion criteria (4 listed)
- congenital malformations;
- genetic syndromes;
- metabolic diseases;
- absence of written consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofunctional assessment for early identification of cerebral palsy motor subtypes and functional prognosisTo determine whether domain-specific findings from the seven-manoeuvre NFA battery support earlier and more precise characterisation of CP motor subtype and functional prognosis. | Other | – |
Primary outcome
gmfm
Time frame: every 6 months up to 2 years
The Gross Motor Function Measure (GMFM-88) is a standardized observational instrument designed and validated to measure changes in gross motor function over time in children with cerebral palsy (CP)
GMDS
Time frame: 2 years
Griffiths Scales of Child Development (Third Edition, or Griffiths III) is a standardized, play-based assessment tool used to measure a child's overall development and create a detailed profile of strengths and needs from birth to 5 years and 11 months of age.
1 secondary outcome
gmds
Time frame: at the end of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 28715518Novak I, Morgan C, Adde L, Blackman J, Boyd RN, Brunstrom-Hernandez J, Cioni G, Damiano D, Darrah J, Eliasson AC, de Vries LS, Einspieler C, Fahey M, Fehlings D, Ferriero DM, Fetters L, Fiori S, Forssberg H, Gordon AM, Greaves S, Guzzetta A, Hadders-Algra M, Harbourne R, Kakooza-Mwesige A, Karlsson P, Krumlinde-Sundholm L, Latal B, Loughran-Fowlds A, Maitre N, McIntyre S, Noritz G, Pennington L, Romeo DM, Shepherd R, Spittle AJ, Thornton M, Valentine J, Walker K, White R, Badawi N. Early, Accurate Diagnosis and Early Intervention in Cerebral Palsy: Advances in Diagnosis and Treatment. JAMA Pediatr. 2017 Sep 1;171(9):897-907. doi: 10.1001/jamapediatrics.2017.1689.
- Background: PubMed 41421834Hadders-Algra M, Tacke U, Pietz J, Philippi H. Cerebral palsy: an update on its early detection. Lancet. 2026 Dec 20;406(10522):2921-2922. doi: 10.1016/S0140-6736(25)02310-4. No abstract available.
- Background: PubMed 38629475Peyton C, Aaby D, Barbosa VM, Boswell L, de Regnier RA, Bos AF, Sukal Moulton T. Baby Observational Selective Control AppRaisal (BabyOSCAR): Scores at 3 months predict functional ability, spastic cerebral palsy distribution, and diagnosis at 2 years. Dev Med Child Neurol. 2024 Nov;66(11):1521-1528. doi: 10.1111/dmcn.15925. Epub 2024 Apr 17.
- Background: PubMed 36175601Picciolini O, Gianni ML, Messina L, Pesenti N, Fumagalli M, Gardon L, Squarza C, Mosca F, Fontana C, Porro M. Development of a new scoring method in the neurofunctional assessment of preterm infants. Sci Rep. 2022 Sep 29;12(1):16335. doi: 10.1038/s41598-022-20754-y.
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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.
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 Early Assessment, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico 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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 4 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
gmfm (time frame: every 6 months up to 2 years). The study lists 2 primary outcomes in all. 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 NCT07916519, 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 4 Nov 2026.