CompletedNot Applicable

Fetoscopic Open Spina Bifida Repair Using the SAFER Technique

Brazil30 participantsStarted 2017-04-01

Plain-language 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.

Who can participate

Age range12 Months – 6 Years

SexALL

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Inclusion Criteria: Children operated in utero using the SAFER technique Exclusion Criteria: Death before 30 month

What they're measuring

Hydrocephalus treatment - shunt or ETV

Timeframe: 12 months corrected age or more

Ambulation

Timeframe: 30 months of cronological age or more

Neurodevelopmental test

Timeframe: 30 months of cronogical age or more

Trial details

NCT IDNCT04356703

SponsorHospital Israelita Albert Einstein

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-09-30

View on ClinicalTrials.gov More Open Spina Bifida trials