Fetoscopic Open Spina Bifida Repair Using the SAFER Technique

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04356703
Study type	Observational
Source	Hospital Israelita Albert Einstein
Contact
Status	Completed
Phase
Start date	April 1, 2017
Completion date	March 1, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06042140` - Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair	N/A
Recruiting	`NCT03562286` - Open Spina Bifida Fetoscopic Repair Project	N/A
Completed	`NCT04468568` - In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline
Recruiting	`NCT03856034` - Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele	N/A
Recruiting	`NCT04362592` - In-Utero Endoscopic Correction of Spina Bifida	N/A
Active, not recruiting	`NCT03936322` - Minimally Invasive Fetoscopic Regenerative Repair of Spina Bifida - A Pilot Study	N/A
Active, not recruiting	`NCT00175123` - Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele	Phase 4
Completed	`NCT02390895` - Prenatal Endoscopic Repair of Fetal Spina Bifida	N/A
Active, not recruiting	`NCT03090633` - Fetoscopic Repair of Isolated Fetal Spina Bifida	N/A
Not yet recruiting	`NCT03088761` - Cuff Pressure in Infants	N/A
Active, not recruiting	`NCT04484441` - Maternal-fetal Immune Responses to Fetal Surgery
Recruiting	`NCT04738539` - Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies
Recruiting	`NCT04652908` - Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial	Phase 1/Phase 2
Terminated	`NCT02493062` - Evaluation of Hysterotomy Site After Open Fetal Surgery	N/A
Completed	`NCT03550898` - Can Dynamic Ultrasonography Replace Urodynamics in Follow-up of Patients With Myelomeningocele	N/A
Active, not recruiting	`NCT04251806` - Sleep-disordered Breathing in Infants With Myelomeningocele
Terminated	`NCT02509377` - Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0	N/A
Recruiting	`NCT03788122` - Fetal Surgery Interview Study: Parental Perceptions of Fetal Surgery	N/A
Recruiting	`NCT02664207` - Extended Criteria For Fetal Myelomeningocele Repair	N/A
Recruiting	`NCT03315637` - Fetal Endoscopic Surgery for Spina Bifida	N/A