Early Identification of Infants at Risk of Cerebral Palsy

CareToy Observational Study: 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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Preterm Infant

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 99

Contacts and Locations

Study Locations

• Italy
  • Pisa
    • Calambrone, Pisa, Italy, 56128
      • IRCCS Fondazione Stella Maris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

For this observational study will be enrolled infants, born a term or preterm, with very early neurological signs (at term age) and evidences of brain lesion during ultrasound brain screening that are considered at risk for the development of CP.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fidgety Movements at 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.	12 weeks post-term age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Writhing Movements at 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).	40 weeks (term age)
Magnetic resonance imaging rating scale	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.	up to 6 weeks (post-term age)

Collaborators and Investigators

• Sponsor: IRCCS Fondazione Stella Maris

Publications and helpful links

General Publications

• Menici V, Antonelli C, Beani E, Mattiola A, Giampietri M, Martini G, Rizzi R, Cecchi A, Cioni ML, Cioni G, Sgandurra G; Caretoy-R Consortium. Feasibility of Early Intervention Through Home-Based and Parent-Delivered Infant Massage in Infants at High Risk for Cerebral Palsy. Front Pediatr. 2021 Jul 19;9:673956. doi: 10.3389/fped.2021.673956. eCollection 2021.
• Sgandurra G, Beani E, Giampietri M, Rizzi R, Cioni G; CareToy-R Consortium. Early intervention at home in infants with congenital brain lesion with CareToy revised: a RCT protocol. BMC Pediatr. 2018 Sep 5;18(1):295. doi: 10.1186/s12887-018-1264-y.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 22, 2017
• Primary Completion (ACTUAL): June 1, 2020
• Study Completion (ACTUAL): June 23, 2020

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (ACTUAL): July 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: MRI; general movements; infants at risk of cerebral palsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: RF-2013-02358095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No