Cerebral PalsyENSEMBLENCT07189494
European Newborn Study: Early Markers for a Better LifE
An observational study of Cerebral Palsy, run by dr. M.J.N.L. Benders at 8 sites in 5 countries.
Trial summary
The goal of this observational study is to create a computer model to help doctors predict any problems occurring during development of babies after being diagnosed with brain injury. This will help provide better care to future babies. Read more about this study
- Who is it for?
- Ages 0 to 2 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 1,000 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 6 Oct 2023to 1 Jan 2029
- 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 0 to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population will include all preterm and term born infants with any brain injury at risk for CP admitted to the neonatal intensive of 8 large European NICUs, high and medium care units, including their parents. Based on a conservative estimate and taking into account incidence of in/exclusion criteria, we expect to include 1000 eligible patients in a total inclusion period of 2.5 years.
Who may be able to join
- All infants with confirmed brain injury on MRI at high risk for CP.
- Particularly, infants with the following brain injuries at risk for CP will be considered on MRI at term equivalent age or within 10 days after birth or sentinel event:
- Extensive punctate white matter injury.
- Periventricular hemorrhagic infarction (any location).
- Cerebellar injury (ischemic and/or hemorrhages) involving the vermis or involving more than 1/3 of the cerebellar hemisphere and/or lesions involving the cerebellar vermis (Meijler \& Steggerda, 2019).
- Cystic periventricular leukomalacia (grade 3 \& 4).
Show all 13Show fewer
- intraventricular hemorrhages grade III.
- Posthemorrhagic ventricular dilatation exceeding the 97°percentile + 4mm for the ventricular index (Cizmeci et al., 2020).
- Perinatal asphyxia with hypoxic ischemic injury of the central gray matter and/or perirolandic area.
- Perinatal asphyxia with hypoxic ischemic injury in the watershed areas.
- Perinatal ischemic arterial stroke at high risk for CP, thus with involvement of the corticospinal tracts, cortex, white matter and basal ganglia (Wagenaar et al., 2018).
- Presence of other brain injuries with expected adverse motor outcome (i.e. big subdural and parenchymal bleedings with/without midline shift, bilirubin induced brain injury) in preterm infants, term infants with neonatal encephalopathy with/without neonatal seizures.
- Written informed parental consent (Dutch, English, French, German, Italian, Spanish).
Who cannot join
- Infants not matching the inclusion criteria.
- Any proven or suspected severe congenital anomaly, genetic or metabolic disorder.
- Presence of an infection of the central nervous system.
- Parents < 18 years old.
- Not being able to read one of the six Informed Consent languages.
Trial locations and contacts
8 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 5 countries
Italy4 sites, 4 recruiting
- Recruiting
Ospedale Pediatrico Meyer Firenze
Florence
Associate Professor of Child Neurology and Psychiatry, +31 088 755 48 03, secrneon@umcutrecht.nl
secrneon@umcutrecht.nl
- Not yet recruiting
Istituto Giannina Gaslini
Genova
Director of the Neonatal Pathology Unit, +31 088 755 48 03, secrneon@umcutrecht.nl
088 755 48 03, secrneon@umcutrecht.nl
- Recruiting
Ospedale Maggiore di Milano
Milan
Associate Professor at Clinical Sciences and Community Health, +31 088 755 48 03, secrneon@umcutrecht.nl
- Recruiting
Fondazione Stella Maris
Pisa
professor of paediatric neurology at the University of Pisa, +31 088 755 48 03, secrneon@umcutrecht.nl
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Paris
Paris
Head of department of NICU, Robert Debre Hospital, +31 088 755 48 03, secrneon@umcutrecht.nl
Germany1 site, 1 recruiting
- Recruiting
University Hospital Essen
Essen
Director and Chair, Department of Paediatrics, +31 088 755 48 03, secrneon@umcutrecht.nl
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht
Director Neonatology, +31 088 755 48 03, secrneon@umcutrecht.nl
Spain1 site, 1 recruiting
- Recruiting
University Hospital La Paz
Madrid
head of the Neonatal Intensive Care Unit, +31 088 755 48 03, secrneon@umcutrecht.nl
About this study
Official title: ENSEMBLE: European Newborn Study: Early Markers for a Better LifE
The goal of this observational study is to create a computer model to help doctors predict any problems occurring during development of babies after being diagnosed with brain injury. This will help provide better care to future babies. Next to this, the experiences of parents or caregivers surrounding the first two years after birth of a baby at risk of developing cerebral palsy will be researched to develop recommendations to support parents.
Parents of participants will:
Read more
- Fill in two online questionnaires, one when their child is 3-4 months corrected age. The second when their child is 2 years corrected age.
For the child no additional tests are needed. Only tests that are part of standard clinical practice are performed and are also saved in the study database.
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, machine learning, diagostic tool
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a machine learning based prediction model
To develop and evaluate a new prediction model using machine learning to predict the risk, severity, and long-term outcome of cerebral palsy (CP) at the level of the individual patient. This model will also provide automatic scoring for each clinical modality (MRI, EEG, GM, HINE, infant cry), which is to be compared with the clinician assessments.
Measured: Neurodevelopmental outcome at 2 years predicted by clinical data from birth to 3-4 months corrected age
Secondary outcomes (1)
Gaining insight into parental mental well-being and family= and social functioning.
To gain insight in parental mental well-being and family- and social functioning, over the first two years after the birth of their child with brain injury, born preterm or full-term, at high risk of developing CP. Including evaluation of parents' experiences around the disclosure of diagnosis, and the impact of these experiences, child-related factors and social support on parental mental well-being. To understand the needs and preferences of parents on the process of disclosure of diagnosis and on information regarding prediction and prognosis, and to identify what information is meaningful to families.
Measured: Parent experience asked in questionnaires at age 3-4 months and 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start6 Oct 2023
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- dr. M.J.N.L. Benders
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Paralysie Cérébrale, Zoundream, CP Nederland, NeuroSpin
- Responsible party
- Sponsor-investigator, dr. M.J.N.L. Benders, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189494
- Sponsor's protocol ID
- NL83183.041.22
- Acronym
- ENSEMBLE
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENSEMBLE: European Newborn Study: Early Markers for a Better LifE
- ClinicalTrials.gov ID
- NCT07189494
- Acronym / sponsor ID
- ENSEMBLE / NL83183.041.22
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, machine learning, diagostic tool
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- dr. M.J.N.L. BendersUniversity, hospital or other
- Collaborators
- Fondation Paralysie Cérébrale, Zoundream, CP Nederland, NeuroSpin
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 24 Sep 2025 (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.
The goal of this observational study is to create a computer model to help doctors predict any problems occurring during development of babies after being diagnosed with brain injury. This will help provide better care to future babies. Next to this, the experiences of parents or caregivers surrounding the first two years after birth of a baby at risk of developing cerebral palsy will be researched to develop recommendations to support parents.
Parents of participants will:
- Fill in two online questionnaires, one when their child is 3-4 months corrected age. The second when their child is 2 years corrected age.
For the child no additional tests are needed. Only tests that are part of standard clinical practice are performed and are also saved in the study database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 0 to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population will include all preterm and term born infants with any brain injury at risk for CP admitted to the neonatal intensive of 8 large European NICUs, high and medium care units, including their parents. Based on a conservative estimate and taking into account incidence of in/exclusion criteria, we expect to include 1000 eligible patients in a total inclusion period of 2.5 years.
Key inclusion criteria (13 listed)
- All infants with confirmed brain injury on MRI at high risk for CP.
- Particularly, infants with the following brain injuries at risk for CP will be considered on MRI at term equivalent age or within 10 days after birth or sentinel event:
- Extensive punctate white matter injury.
- Periventricular hemorrhagic infarction (any location).
- Cerebellar injury (ischemic and/or hemorrhages) involving the vermis or involving more than 1/3 of the cerebellar hemisphere and/or lesions involving the cerebellar vermis (Meijler \& Steggerda, 2019).
Key exclusion criteria (5 listed)
- Infants not matching the inclusion criteria.
- Any proven or suspected severe congenital anomaly, genetic or metabolic disorder.
- Presence of an infection of the central nervous system.
- Parents < 18 years old.
- Not being able to read one of the six Informed Consent languages.
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
Development of a machine learning based prediction model
Time frame: Neurodevelopmental outcome at 2 years predicted by clinical data from birth to 3-4 months corrected age
To develop and evaluate a new prediction model using machine learning to predict the risk, severity, and long-term outcome of cerebral palsy (CP) at the level of the individual patient. This model will also provide automatic scoring for each clinical modality (MRI, EEG, GM, HINE, infant cry), which is to be compared with the clinician assessments.
1 secondary outcome
Gaining insight into parental mental well-being and family= and social functioning.
Time frame: Parent experience asked in questionnaires at age 3-4 months and 2 years.
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 24 Sep 2025.
- Individual participant dataSharing planned: Yes
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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.
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by dr. M.J.N.L. Benders at 8 sites in 5 countries.
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 13 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, France, Germany, Netherlands, Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a machine learning based prediction model (time frame: Neurodevelopmental outcome at 2 years predicted by clinical data from birth to 3-4 months corrected age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2025.