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Fetoscopic Open Spina Bifida Repair Using the SAFER Technique

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04356703
Recruitment Status : Completed
First Posted : April 22, 2020
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital Israelita Albert Einstein

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.

Condition or disease Intervention/treatment
Open Spina Bifida Myelomeningocele Meningomyelocele Chiari Malformation With Spina Bifida Chiari Malformation Type 2 Other: Neuropsicomotor developmental test

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Prenatal Correction of Spina Bifida Using Fetoscopy and the SAFER Technique on Long-term Neurodevelopment.
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : March 1, 2020


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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Anatomical verus motor level [ Time Frame: 30 months of cronological age or more ]
    To compare anatomical level with motor level



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children submitted to prenatal repair of open spina bifida using the fetoscopic percutaneous repair technique - SAFER
Criteria

Inclusion Criteria:

Children operated in utero using the SAFER technique

Exclusion Criteria:

Death before 30 month


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04356703


Locations
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Brazil
Hospital Israelita Albert Einstein
Sao Paulo, SP, Brazil
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Investigators
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Principal Investigator: DENISE A LAPA, MD Hospital Israelita Albert Einstein
Additional Information:
Publications:

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Responsible Party: Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT04356703    
Other Study ID Numbers: HIAE-SAFER
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Israelita Albert Einstein:
myelomeningocele
spina bifida
meningomyelocele
fetal surgery
fetoscopy
fetal disease
fetal treatment
Additional relevant MeSH terms:
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Spinal Dysraphism
Meningomyelocele
Spina Bifida Cystica
Arnold-Chiari Malformation
Congenital Abnormalities
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases