Early Identification of Infants at Risk of Cerebral Palsy

NCT03211533 | Completed DMC

• 1 other identifier: RF-2013-02358095
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy; Preterm Infant

Keywords

infants at risk of cerebral palsy; MRI; general movements

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Writhing Movements at 40 weeks (term age)

  40 weeks (term age)

• Magnetic resonance imaging rating scale

  up to 6 weeks (post-term age)

Eligibility Criteria

• Age: Up to 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• brain malformations
• severe sensory deficits

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead

Study Sites (1)

IRCCS Fondazione Stella Maris

Calambrone, Pisa, 56128, Italy

Location

Related Publications (3)

• Franchi De' Cavalieri M, Filogna S, Martini G, Beani E, Maselli M, Cianchetti M, Dubbini N, Cioni G, Sgandurra G; CareToy-R Consortium. Wearable accelerometers for measuring and monitoring the motor behaviour of infants with brain damage during CareToy-Revised training. J Neuroeng Rehabil. 2023 May 6;20(1):62. doi: 10.1186/s12984-023-01182-z.

  PMID: 37149595 DERIVED

• 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.

  PMID: 34350144 DERIVED

• 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.

  PMID: 30185165 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Premature Birth

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 7, 2017
• Study Start: July 22, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 23, 2020
• Last Updated: November 17, 2020

Record last verified: 2019-10

Locations

IT (1)