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Completed

NCT Number: NCT03211533

Early Identification of Infants at Risk of Cerebral Palsy

This observational study aims to early identify, through a rigorous and standardized follow-up, infants at high risk for Cerebral Palsy. After the consent agreement firmed by the parents, infants born at term or preterm with ultrasonographic evidence of brain injury considered at risk for neurodevelopmental disorders will be strictly monitored during the first months of life performing a periodic neurological assessment (Prechtl's General Movement (GMA) and the Hammersmith Infant Neurological Examination) at term age and around 3 months of post term age. Moreover, to study more accurately the brain injury early identified by ultrasonographic brain exam, around 6 weeks of post-term age the enrolled infants will perform, as recommended in infants at risk, brain Magnetic Resonance (RM).

Thanks to the high predictability power of the combination of the clinical observation with the neuroimaging infants at high risk of CP will be early detect. Selected infants, considered at high risk for CP will have the opportunity to perform an home based and family centered early intervention later than 3 post term age.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Female Urogenital Diseases and Pregnancy Complications Nervous System Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Infant Urogenital Diseases

Age range

Up to 5 month

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Fondazione Stella Maris

Calambrone, Pisa, 56128, Italy

About this study

Scientific literature review shows evidence that early intervention, especially when performed in the first months of life, when the brain plasticity shows its great expressivity, has positive effects on neurodevelopmental outcomes. In this framework the early identification of infants at risk for neurodevelopmental disorders is a major prerequisite to start very early an intervention programme. To families of infants, born in Neonatal Units involved in this study, will be asked with written informed consent, to participate in this observational study that aims to early identify, through a rigorous and standardized follow-up, infants at high risk for CP. Infants born at term or preterm with ultrasonographic evidence of brain injury considered at risk for neurodevelopmental disorders will be strictly monitored during the first months of development by the clinical team (Child Neurologists and Neonatologists) performing a periodic neurological assessment through examination of the Prechtl's General Movement (GMA) and the Hammersmith Infant Neurological Examination, at term age and around 3 months of post term age. Moreover, to study more accurately the brain injury early identified by ultrasonographic brain exam, within 6 weeks post-term age enrolled infants will perform, as recommended in infants at risk, brain Magnetic Resonance (RM). During the conventional RM examination, when possible, a fMRI perceptive task will be also performed to evaluate possible predictor factors to the responsiveness to the early intervention.

Thanks to the high predictability power of the combination of the clinical observation with the neuroimaging infants at high risk of CP will be early detect. Selected infants, considered at high risk for CP will have the opportunity to perform an home based and family centered early intervention later than 3 post term age.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • neurological signs (Hammersmith Infant Neurological Examination/General Movement Assessment according Precthl's).
  • signs of brain injury identified at ultrasound brain exam

Exclusion criteria

  • brain malformations
  • severe sensory deficits

Treatment and study plan

Primary outcomes

  1. Fidgety Movements at 12 weeks (post-term age)

    Time frame: 12 weeks post-term age

    The Prechtl's General Movements Assessment is a non-invasive and cost-effective way to identify neurological issues which may lead to cerebral palsy and other developmental disabilities. The Fidgety movements are usually assessed between 9-20 weeks post-term age, showing the best expression at 12 weeks post term age. Infants whose Fidgety movements are absent or abnormal are at higher risk of neurological conditions, in particular for cerebral palsy.

Secondary outcomes

  1. Writhing Movements at 40 weeks (term age)

    Time frame: 40 weeks (term age)

    The 'writhing movements' (described in the Prechtl's General Movements Assessment) are present from term age until 8 weeks post-term age. The evaluation at 40 weeks is a key point for the assessment both in preterm and at term infants. Infants whose writhing movements are abnormal could be considered at risk for neurodevelopmental disabilities; they have been carefully monitored in the fidgety period (see primary outcome measure).

  2. Magnetic resonance imaging rating scale

    Time frame: up to 6 weeks (post-term age)

    Infants recruited will perform, according to gold standard clinical guidelines, a MRI study of the brain lesion previously identified with brain ultrasound. MRI will allow to better study the type of lesion. It will be quantified according to a validated visual semi-quantitative rating scale that uses a reliable and valid anatomical template for a graphical representation of abnormal MRI findings with detailed scoring of relative brain structures. During the MRI a task of fMRI will be performed to identify predictors of response to treatment.

Sponsors and collaborators

Lead sponsor

IRCCS Fondazione Stella Maris

Other

Registry information

Official study title

CareToy Observational Study: Early Identification of Infants at Risk of Cerebral Palsy

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 7, 2017
Registry last updated
Nov 17, 2020

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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