Fetoscopic Open Spina Bifida Repair Using the SAFER Technique

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Open Spina Bifida, Myelomeningocele, Meningomyelocele, Chiari Malformation With Spina Bifida, Chiari Malformation Type 2

Intervention / Treatment
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* Other: Neuropsicomotor developmental test


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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children submitted to fetoscopic surgery<br>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 | Other: Neuropsicomotor developmental test<br>* Children will be evaluated trough Bayley III and PEDI scale. They also will be examined by pediatrician, neurosurgeon, orthopedics and phisiatry<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical verus motor level | To compare anatomical level with motor level | 30 months of cronological age or more | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myelomeningocele, spina bifida, meningomyelocele, fetal surgery, fetoscopy, fetal disease, fetal treatment