Fetoscopic Open Spina Bifida Repair Using the SAFER Technique

Completed

• Conditions: Chiari Malformation With Spina Bifida; Myelomeningocele; Meningomyelocele; Chiari Malformation Type 2; Open Spina Bifida
• Interventions: Other: Neuropsicomotor developmental test

• Registration Number: NCT04356703
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief 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.

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2019-09-30
• Study Completion: 2020-03-01
• Status Verified: 2020-04
• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-20
• Last Update Submitted: 2020-04-20
• Study First Posted: 2020-04-22
• Last Update Posted: 2020-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Children operated in utero using the SAFER technique

Exclusion Criteria

Death before 30 month

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children submitted to fetoscopic surgery	Neuropsicomotor developmental test	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

Primary Outcome Measures

Name	Time	Method
Ambulation	30 months of cronological age or more	Ambulation Status
Hydrocephalus treatment - shunt or ETV	12 months corrected age or more	Need to treat hydrocephaly in the first year of life
Neurodevelopmental test	30 months of cronogical age or more	PEDI scale will be performed

Secondary Outcome Measures

Name	Time	Method
Anatomical verus motor level	30 months of cronological age or more	To compare anatomical level with motor level

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 Sao Paulo, SP, Brazil