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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children submitted to fetoscopic surgery | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuropsicomotor developmental test | Other | Children will be evaluated trough Bayley III and PEDI scale. They also will be examined by pediatrician, neurosurgeon, orthopedics and phisiatry |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Anatomical verus motor level | To compare anatomical level with motor level | 30 months of cronological age or more |
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Inclusion Criteria:
Children operated in utero using the SAFER technique
Exclusion Criteria:
Death before 30 month
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Children submitted to prenatal repair of open spina bifida using the fetoscopic percutaneous repair technique - SAFER
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| Name | Affiliation | Role |
|---|---|---|
| DENISE A LAPA, MD | Hospital Israelita Albert Einstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Israelita Albert Einstein | São Paulo | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31169957 | Background | Sanz Cortes M, Lapa DA, Acacio GL, Belfort M, Carreras E, Maiz N, Peiro JL, Lim FY, Miller J, Baschat A, Sepulveda G, Davila I, Gielchinsky Y, Benifla M, Stirnemann J, Ville Y, Yamamoto M, Figueroa H, Simpson L, Nicolaides KH. Proceedings of the First Annual Meeting of the International Fetoscopic Myelomeningocele Repair Consortium. Ultrasound Obstet Gynecol. 2019 Jun;53(6):855-863. doi: 10.1002/uog.20308. No abstract available. | |
| 29936963 |
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| ID | Term |
|---|---|
| D016137 | Spina Bifida Cystica |
| D008591 | Meningomyelocele |
| D001139 | Arnold-Chiari Malformation |
| D016135 | Spinal Dysraphism |
| D005315 | Fetal Diseases |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
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| Background |
| Lapa DA. Prenatal superior to postnatal myelomeningocele surgery. J Pediatr. 2018 Jul;198:322-325. doi: 10.1016/j.jpeds.2018.04.060. No abstract available. |
| 31350160 | Background | Lapa DA. Endoscopic fetal surgery for neural tube defects. Best Pract Res Clin Obstet Gynaecol. 2019 Jul;58:133-141. doi: 10.1016/j.bpobgyn.2019.05.001. Epub 2019 Jun 29. |
| 31574466 | Background | Carrabba G, Macchini F, Fabietti I, Schisano L, Meccariello G, Campanella R, Bertani G, Locatelli M, Boito S, Porro GA, Gabetta L, Picciolini O, Cinnante C, Triulzi F, Ciralli F, Mosca F, Lapa DA, Leva E, Rampini P, Persico N. Minimally invasive fetal surgery for myelomeningocele: preliminary report from a single center. Neurosurg Focus. 2019 Oct 1;47(4):E12. doi: 10.3171/2019.8.FOCUS19438. |
| 26386383 | Background | Pedreira DA, Zanon N, Nishikuni K, Moreira de Sa RA, Acacio GL, Chmait RH, Kontopoulos EV, Quintero RA. Endoscopic surgery for the antenatal treatment of myelomeningocele: the CECAM trial. Am J Obstet Gynecol. 2016 Jan;214(1):111.e1-111.e11. doi: 10.1016/j.ajog.2015.09.065. Epub 2015 Sep 18. |
| 23386086 | Background | Herrera SR, Leme RJ, Valente PR, Caldini EG, Saldiva PH, Pedreira DA. Comparison between two surgical techniques for prenatal correction of meningomyelocele in sheep. Einstein (Sao Paulo). 2012 Oct-Dec;10(4):455-61. doi: 10.1590/s1679-45082012000400011. English, Portuguese. |
| 21848412 | Background | Pedreira DA, Quintero RA, Acacio GL, Caldini ET, Saldiva PH. Neoskin development in the fetus with the use of a three-layer graft: an animal model for in utero closure of large skin defects. J Matern Fetal Neonatal Med. 2011 Oct;24(10):1243-8. doi: 10.3109/14767058.2011.564486. Epub 2011 Aug 17. |
| 17546289 | Background | Sanchez e Oliveira Rde C, Valente PR, Abou-Jamra RC, Araujo A, Saldiva PH, Pedreira DA. Biosynthetic cellulose induces the formation of a neoduramater following pre-natal correction of meningomyelocele in fetal sheep. Acta Cir Bras. 2007 May-Jun;22(3):174-81. doi: 10.1590/s0102-86502007000300004. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |