Status:
NOT_YET_RECRUITING
Early Prosthetics in Children With Upper Limb Deficiency
Lead Sponsor:
University Hospital, Lille
Conditions:
Limb Deficiencies
Eligibility:
All Genders
1-3 years
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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 disease operated on: transposition of the large vessels; left ventricular hypoplastic syndrome.
- Perinatal exposure to a major toxicant: certain antiepileptics (sodium valproate); severe exposure to alcohol and / or with signs of fetal disease.
- Major, prolonged and repeated surgery (cardiac, cerebral, abdominal, thoracic).
- Exclusion of all deficiency forming part of a polymalformative, vascular syndrome (Poland syndrome), genetic cause ...
- Exclusion of all other forms of agenesis (bilateral, longitudinal, persistence of hand remains),
- Refusal of consent from one or both parents
Key Trial Info
Start Date :
May 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04851600
Start Date
May 1 2021
End Date
May 1 2026
Last Update
April 20 2021
Active Locations (1)
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1
Ssr Pediatrique Marc Sautelet
Villeneuve-d'Ascq, France