Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000330943
Ethics application status
Approved
Date submitted
18/03/2011
Date registered
29/03/2011
Date last updated
29/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Neuromotor assessment in patients with myelomeningocele submitted to intrauterine surgery
Scientific title
Neuromotor assessment in patients with myelomeningocele submitted to intrauterine surgery
Secondary ID [1] 259813 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal malformation 265395 0
Condition category
Condition code
Physical Medicine / Rehabilitation 265549 265549 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational Study
Period: four years
It was observed neuromotor development in patientes that submitted to inrtauterine surgery by Hoffer Classification. It was analyzed the cognitive level by Columbia Mental Scale and the socioeconomic level by Brazilian Economic Classification Test.
Intervention code [1] 264243 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262357 0
The results showed that six cases(100%) that underwent intrauterine surgical repair demonstrated better functional motor development in relation to the anatomic lesion by Hoffer Classification.
Timepoint [1] 262357 0
In three years after born
Secondary outcome [1] 273622 0
Only two patients (33,33%) that underwent intrauterine surgery developed hydrocephalia. It was observed by ressonance magnetic test.
Timepoint [1] 273622 0
In one month after birth

Eligibility
Key inclusion criteria
Patients with clinical diagnosis of myelomeningocele
Patients submitted to intrauterine surgery
Children born by cesarean section
Minimum age
3 Years
Maximum age
4 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with myelomeningocele no submitted to intrauterine surgery

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment outside Australia
Country [1] 3304 0
Brazil
State/province [1] 3304 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 264695 0
University
Name [1] 264695 0
Federal University of Sao Paulo
Country [1] 264695 0
Brazil
Primary sponsor type
University
Name
Federal University of Sao Paulo
Address
Napoleao de Barro, 715 6 andar
Vila Clementino
Sao Paulo
Zip code 04039900
Country
Brazil
Secondary sponsor category [1] 263827 0
None
Name [1] 263827 0
Address [1] 263827 0
Country [1] 263827 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266686 0
Committee Ethic of Federal University of Sao Paulo
Ethics committee address [1] 266686 0
Botucatu,572 conj 14
Sao Paulo, Brazil
zip code 04039900
Ethics committee country [1] 266686 0
Brazil
Date submitted for ethics approval [1] 266686 0
Approval date [1] 266686 0
03/04/2006
Ethics approval number [1] 266686 0
1/04/0864

Summary
Brief summary
Investigate the neuromotor development of patients with myelomeningocele either submitted to intrauterine surgery, describe anatomical and functional motor levels, the hydrocephalia, and analyze socioeconomic and cognitive levels.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 32359 0
Address 32359 0
Country 32359 0
Phone 32359 0
Fax 32359 0
Email 32359 0
Contact person for public queries
Name 15606 0
Tereza Cristina Carbonari de Faria
Address 15606 0
Adolfo Figueiredo Rodrigues, 682
Mogi das Cruzes SP
zip code 08770555
Country 15606 0
Brazil
Phone 15606 0
55 11 47901747
Fax 15606 0
55 11 4790 1747
Email 15606 0
t.faria@uol.com.br
Contact person for scientific queries
Name 6534 0
Tereza Cristina Carbonari de Faria
Address 6534 0
Adolfo Figueiredo Rodrigues, 682
Mogi das Cruzes SP
zip code 08770555
Country 6534 0
Brazil
Phone 6534 0
55 11 4790 1747
Fax 6534 0
55 11 4790 1747
Email 6534 0
t.faria@uol.com.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.