Early Prosthetics in Children With Upper Limb Deficiency (NCT04851600) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Early Prosthetics in Children With Upper Limb Deficiency
France30 participantsStarted 2021-05
Plain-language summary
For children with congenital upper limb deficiency, introduction of the prosthesis is guided by clinical experience rather than by Evidence Based Medicine.
This study will assess early development in children with upper limb deficiency according to age at the introduction of the prosthesis.
This study will give new keys in these specific prosthesis cares.
Who can participate
Age range1 Month – 3 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female child
* Aged from 1 month to 3 months and a half
* Placement of a prosthesis in a patient with isolated upper limb deficiency, type of congenital transverse unilateral amputation of the forearm segment
* Socially insured patient,
* Patient willing to comply with all study procedures and study duration
* Written informed consent from patient's legal guardians
Exclusion Criteria:
* Children with one or more high risk factors for neurodevelopmental disorders:
* Very prematurity (\<32 weeks of amenorrhea \[SA\])
* Premature infants \<37 WA with intrauterine growth retardation (IUGR) or low weight for gestational age (PAG) \<3rd percentile or \<- 2 SD for GA and sex according to national reference curves)
* A presumed hypoxo-ischemic encephalopathy with an indication of therapeutic hypothermia
* A perinatal arterial cerebrovascular accident (AVC) (diagnosed between the 20th week of fetal life and the 28th day of life including in premature newborns).
* Cerebral growth anomalies: microcephaly with cranial perimeter \<- 2 SD at birth verified secondarily or macrocephaly\> + 3 SD for the term (persisting after a second measurement).
* A family history of severe first-degree neurodevelopmental disorder (brother or sister or parent)
* Symptomatic congenital cytomegalovirus infections and other infectious fetopathies: toxoplasmosis, Zika, rubella, etc.
* Bacterial and viral herpetic meningoencephalitis
* Complex congenital heart…
What they're measuring
1
Vineland Adaptive Behavior Scales version II Motor skills Domain score Motor skills Domain score