European Newborn Study: Early Markers for a Better LifE

Официальное название

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

Обзор

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.

Первичные конечные точки

• Development of a machine learning based prediction model [Срок оценки: Neurodevelopmental outcome at 2 years predicted by clinical data from birth to 3-4 months corrected age]

Вторичные конечные точки (1)

• Gaining insight into parental mental well-being and family= and social functioning. [Срок оценки: Parent experience asked in questionnaires at age 3-4 months and 2 years.]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 4 центра

• Ospedale Pediatrico Meyer Firenze — Florence
• Istituto Giannina Gaslini — Genova
• Ospedale Maggiore di Milano — Milan
• Fondazione Stella Maris — Pisa

Франция · 1 центр

• Assistance Publique Hôpitaux de Paris — Paris

Германия · 1 центр

• University Hospital Essen — Essen

Нидерланды · 1 центр

• UMC Utrecht — Utrecht

Испания · 1 центр

• University Hospital La Paz — Madrid

Идентификаторы

NCT: NCT07189494 · NL83183.041.22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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