NCT04356703

Fetoscopic Open Spina Bifida Repair Using the SAFER Technique

Impact of Prenatal Correction of Spina Bifida Using Fetoscopy and the SAFER Technique on Long-term Neurodevelopment.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Hospital Israelita Albert Einstein · Academic / Other
• Sex: All
• Age: 12 Months – 6 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Open Spina Bifida
• Myelomeningocele
• Meningomyelocele
• Chiari Malformation With Spina Bifida
• Chiari Malformation Type 2

Interventions

Type	Name	Description
OTHER	Neuropsicomotor developmental test	Children will be evaluated trough Bayley III and PEDI scale. They also will be examined by pediatrician, neurosurgeon, orthopedics and phisiatry

Timeline

• Start date: 2017-04-01
• Primary completion: 2019-09-30
• Completion: 2020-03-01
• First posted: 2020-04-22
• Last updated: 2020-04-22

Locations

1 site across 1 country: Brazil