European Newborn Study: Early Markers for a Better LifE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy. Basic parameters: 0 years — 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Germany, Italy, Netherlands, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ENSEMBLE: European Newborn Study: Early Markers for a Better LifE
Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (1)
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 4 centers
- Ospedale Pediatrico Meyer Firenze — Florence
- Istituto Giannina Gaslini — Genova
- Ospedale Maggiore di Milano — Milan
- Fondazione Stella Maris — Pisa
France · 1 center
- Assistance Publique Hôpitaux de Paris — Paris
Germany · 1 center
- University Hospital Essen — Essen
Netherlands · 1 center
- UMC Utrecht — Utrecht
Spain · 1 center
- University Hospital La Paz — Madrid
Identifiers
NCT: NCT07189494 · NL83183.041.22