Fetoscopic Open Spina Bifida Repair Using the SAFER Technique

Hospital Israelita Albert Einstein

Status: Completed

Conditions: Open Spina Bifida; Meningomyelocele; Chiari Malformation Type 2; Chiari Malformation With Spina Bifida; Myelomeningocele

Treatments: Other: Neuropsicomotor developmental test

Study type: Observational

Funder types: Other

Identifiers

NCT04356703

HIAE-SAFER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 12 months to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Children operated in utero using the SAFER technique

Exclusion criteria

Death before 30 month

Trial design

30 participants in 1 patient group

Children submitted to fetoscopic surgery

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 or older

Treatment:

Other: Neuropsicomotor developmental test