European Newborn Study: Early Markers for a Better LifE

NCT07189494 | Recruiting

• 1 other identifier: NL83183.041.22
• Study Type: observational
• Target: 1,000
• Locations: 5 countries
• Sites: 8

Brief 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. 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.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; machine learning; diagostic tool

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Parent experience asked in questionnaires at age 3-4 months and 2 years.

Eligibility Criteria

• Age: 0 Years - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• dr. M.J.N.L. Benders: lead
• Fondation Paralysie Cérébrale: collaborator
• Zoundream: collaborator
• CP Nederland: collaborator
• NeuroSpin: collaborator

Study Sites (8)

Assistance Publique Hôpitaux de Paris

Paris, France

RECRUITING

University Hospital Essen

Essen, Germany

RECRUITING

Ospedale Pediatrico Meyer Firenze

Florence, Italy

RECRUITING

Istituto Giannina Gaslini

Genova, Italy

NOT YET RECRUITING

Ospedale Maggiore di Milano

Milan, Italy

RECRUITING

Fondazione Stella Maris

Pisa, Italy

RECRUITING

UMC Utrecht

Utrecht, Netherlands

RECRUITING

University Hospital La Paz

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 24, 2025
• Study Start: October 6, 2023
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

FR (1); IT (4); NL (1); DE (1); ES (1)