Fetoscopic Open Spina Bifida Repair Using the SAFER Technique

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04356703

Enrollment

Registered

2020-04-22

Start date

2017-04-01

Completion date

2020-03-01

Last updated

2020-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed 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.

Interventions

OTHERNeuropsicomotor developmental test

Children will be evaluated trough Bayley III and PEDI scale. They also will be examined by pediatrician, neurosurgeon, orthopedics and phisiatry

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Months to 6 Years

Healthy volunteers

Inclusion criteria

Children operated in utero using the SAFER technique

Exclusion criteria

Death before 30 month

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Anatomical verus motor level	30 months of cronological age or more	To compare anatomical level with motor level

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026