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:

- 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.

Recruiting

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

0 year–2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique Hôpitaux de Paris, Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).
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).

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.

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.

Sponsors and collaborators

Lead sponsor

dr. M.J.N.L. Benders

Other

Collaborators

CP Nederland
Fondation Paralysie Cérébrale
NeuroSpin
Zoundream

Registry information

Official study title

ENSEMBLE: European Newborn Study: Early Markers for a Better LifE

Acronym: ENSEMBLE

Important dates

Study start: 2023
Primary completion: 2029
Study completion: 2029
First posted: Sep 24, 2025
Registry last updated: Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting