At a glance
ClinicalIndex Comparison RecordN/ACompleted· 30 enrolled
Drug / intervention
Neuropsicomotor developmental testother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Impact of Prenatal Correction of Spina Bifida Using Fetoscopy and the SAFER Technique on Long-term Neurodevelopment.
In Brief
An observational study evaluating Neuropsicomotor developmental test for Open Spina Bifida and 4 related conditions. Completed, enrolled 30 participants across 1 site.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsOpen Spina Bifida, Myelomeningocele, Meningomyelocele, Chiari Malformation With Spina Bifida, Chiari Malformation Type 2
CountriesBrazil
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
Enrollment StartApr 2017
Primary CompletionSep 2019
Study CompletionMar 2020
First PostedApr 2020
TodayJul 2026
First PostedApr 22, 2020
Enrollment StartApr 1, 2017
Primary CompletionSep 30, 2019
Study CompletionMar 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.2 years ago
Interventions
Neuropsicomotor developmental testother
Children will be evaluated trough Bayley III and PEDI scale. They also will be examined by pediatrician, neurosurgeon, orthopedics and phisiatry