Fetoscopic Open Spina Bifida Repair Using the SAFER Technique

Status Completed

Clinical Trial Summary

Children submitted to fetoscopic in utero myelomeningocele repair using the SAFER (Skin-over-biocellulose for Anternatal FEtoscopic Repair) technique will evaluate at 30 months or more, regarding ambulation, neurodevelopment, urinary and fecal status.

Clinical Trial Description

Children submitted to fetoscopic in utero myelomeningocele repair using the SAFER (Skin-over-biocellulose for Anternatal FEtoscopic Repair) technique will evaluate the neuropsicomotor development at 30 months of chronological age. The mental evaluation will use the Bayley III and thePEDI neurodevelopmental scale. The motor development will use the difference between anatomic and motor level of the lesion. Urinary and fecal continence will be evaluated using clinical and ultrasonographic parameters. For the anatomical level determination, immaging of the spine at the lesion level will be used. Motor level and ambulation will be evaluated through standard clinical examination. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04356703
Study type	Observational
Source	Hospital Israelita Albert Einstein
Contact
Status	Completed
Phase
Start date	April 1, 2017
Completion date	March 1, 2020

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See also
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