Fetoscopic Open Spina Bifida Repair Using the SAFER Technique

Myelomeningocele Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04356703
• Other study ID #: HIAE-SAFER
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2020
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 6 Years

Eligibility

Inclusion Criteria:

Children operated in utero using the SAFER technique

Exclusion Criteria:

Death before 30 month

Related Conditions & MeSH terms

• Arnold-Chiari Malformation
• Chiari Malformation Type 2
• Chiari Malformation With Spina Bifida
• Congenital Abnormalities
• Meningomyelocele
• Myelomeningocele
• Open Spina Bifida
• Spinal Dysraphism

Intervention

Other:
• Neuropsicomotor developmental test
Children will be evaluated trough Bayley III and PEDI scale. They also will be examined by pediatrician, neurosurgeon, orthopedics and phisiatry

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

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. — View Citation

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. English, Portuguese. — View Citation

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. Review. — View Citation

Lapa DA. Prenatal superior to postnatal myelomeningocele surgery. J Pediatr. 2018 Jul;198:322-325. doi: 10.1016/j.jpeds.2018.04.060. — View Citation

Pedreira DA, Quintero RA, Acácio 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. — View Citation

Pedreira DA, Zanon N, Nishikuni K, Moreira de Sá 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. — View Citation

Sanchez e Oliveira Rde C, Valente PR, Abou-Jamra RC, Araújo 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hydrocephalus treatment - shunt or ETV	Need to treat hydrocephaly in the first year of life	12 months corrected age or more
Primary	Ambulation	Ambulation Status	30 months of cronological age or more
Primary	Neurodevelopmental test	PEDI scale will be performed	30 months of cronogical age or more
Secondary	Anatomical verus motor level	To compare anatomical level with motor level	30 months of cronological age or more

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