Early Prosthetics in Children With Upper Limb Deficiency

NCT ID: NCT04851600

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2026-05-31

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 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.

Conditions

Limb Deficiencies

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Early introduction

Casting and delivery of a cosmetic upper limb prosthesis at 3-4 months old of age.

prosthesis

Intervention Type: DEVICE

Casting and delivery of a cosmetic upper limb prosthesis at 3-4 months old of age.

Interventions

prosthesis

Casting and delivery of a cosmetic upper limb prosthesis at 3-4 months old of age.

Intervention Type: DEVICE

Eligibility Criteria

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 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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alice TAQUET, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Ssr Pediatrique Marc Sautelet

Villeneuve-d'Ascq, , France

Countries

France

Central Contacts

Alice TAQUET, MD

Role: CONTACT

alice.taquet@marcsautelet.com

03 28 80 07 70 ext. +33

Facility Contacts

Role: primary

0328800770

Other Identifiers

2021-A00108-33

Identifier Type: OTHER

Identifier Source: secondary_id

2020_24

Identifier Type: -

Identifier Source: org_study_id