Fetoscopic Open Spina Bifida Repair Using the SAFER Technique

NCT04356703 | Completed DMC

• 1 other identifier: HIAE-SAFER
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Open Spina Bifida; Myelomeningocele; Meningomyelocele; Chiari Malformation With Spina Bifida; Chiari Malformation Type 2

Keywords

myelomeningocele; spina bifida; meningomyelocele; fetal surgery; fetoscopy; fetal disease; fetal treatment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Anatomical verus motor level

  30 months of cronological age or more

Study Arms (1)

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

Other: Neuropsicomotor developmental test

Interventions

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

Children submitted to fetoscopic surgery

Eligibility Criteria

• Age: 12 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children submitted to prenatal repair of open spina bifida using the fetoscopic percutaneous repair technique - SAFER

You may qualify if:

• Children operated in utero using the SAFER technique

You may not qualify if:

• Death before 30 month

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Location

Related Publications (8)

• 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.

  PMID: 31169957 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.

  PMID: 29936963 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.

  PMID: 31350160 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.

  PMID: 31574466 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.

  PMID: 26386383 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.

  PMID: 23386086 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.

  PMID: 21848412 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.

  PMID: 17546289 BACKGROUND

MeSH Terms

Conditions

Spina Bifida Cystica; Meningomyelocele; Arnold-Chiari Malformation; Spinal Dysraphism; Fetal Diseases

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• DENISE A LAPA, MD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 22, 2020
• Study Start: April 1, 2017
• Primary Completion: September 30, 2019
• Study Completion: March 1, 2020
• Last Updated: April 22, 2020

Record last verified: 2020-04

Locations

BR (1)