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OpenTrials
Completed

NCT Number: NCT04356703

Fetoscopic Open Spina Bifida Repair Using the SAFER Technique

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.

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Key information

Conditions

Open Spina Bifida Arnold-Chiari Malformation Chiari Malformation Type 2 Chiari Malformation With Spina Bifida Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Meningomyelocele Myelomeningocele Nervous System Diseases Nervous System Malformations Neural Tube Defects Pregnancy Complications Spina Bifida Cystica Spinal Dysraphism Urogenital Diseases

Age range

12 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Israelita Albert Einstein

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children operated in utero using the SAFER technique

Exclusion criteria

Death before 30 month

Treatment and study plan

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

Primary outcomes

  1. Hydrocephalus treatment - shunt or ETV

    Time frame: 12 months corrected age or more

    Need to treat hydrocephaly in the first year of life

  2. Ambulation

    Time frame: 30 months of cronological age or more

    Ambulation Status

  3. Neurodevelopmental test

    Time frame: 30 months of cronogical age or more

    PEDI scale will be performed

Secondary outcomes

  1. Anatomical verus motor level

    Time frame: 30 months of cronological age or more

    To compare anatomical level with motor level

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Apr 22, 2020
Registry last updated
Apr 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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