Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000314224
Ethics application status
Approved
Date submitted
15/03/2009
Date registered
21/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Transitory hypertonia in preterm infants during their first year of file: Clinical study and prognostic value
Scientific title
Observation and analysis of the evolution of transitory hypertonia in preterm infants during their first year of life
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transitory hypertonia 4478 0
Condition category
Condition code
Neurological 4751 4751 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 4752 4752 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Analyisis of transitory hypertonia evolution during preterm infant's first year of life (evaluation: at least once a trimester)
Intervention code [1] 4221 0
Not applicable
Comparator / control treatment
There's no control group, at the end the participants were divided according the outcome (presence or not of the hypertonia).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5617 0
Evolution of transitory hypertonia, which were assessed by the observation of muscle resistance to stretching during passive movement. Using a goniometer the joint angles were also measured.
Timepoint [1] 5617 0
The evaluation were done at least once a trimester during preterm infant's first year of life.
Primary outcome [2] 5618 0
Relation between transitory hypertonia and maternal factors and intercurrences. This outcome were assessed by the statistical comparison of both group factors
Timepoint [2] 5618 0
At trial end the participants were divided into two groups according the presence or not of transitory hypertonia. The factor were taken from mothers/infants medical records.
Primary outcome [3] 5619 0
Statistical analysis of transitory hypertonia incidence.
Timepoint [3] 5619 0
The evaluation were done at least once a trimester during preterm infant's first year of life.
Secondary outcome [1] 9458 0
motordevelopment of preterm infants were observed according Gesell & Amatruda scale
Timepoint [1] 9458 0
The evaluation were done at least once a trimester during preterm infant's first year of life.

Eligibility
Key inclusion criteria
preterm infants with gestational ages equal or under 34 weeks and with normal cranial ultrasound
Minimum age
No limit
Maximum age
3 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
genetic problems

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment outside Australia
Country [1] 1683 0
Brazil
State/province [1] 1683 0

Funding & Sponsors
Funding source category [1] 4668 0
Self funded/Unfunded
Name [1] 4668 0
Country [1] 4668 0
Primary sponsor type
University
Name
Faculdade de Ciencias Medicas da Santa Casa de Sao Paulo
Address
rua Cesario Motta Junior, 112 - Sao Paulo/SP - 01221-900
Country
Brazil
Secondary sponsor category [1] 4214 0
Individual
Name [1] 4214 0
Walkira Basile Brunetti
Address [1] 4214 0
rua Profa Wanda Perseguin, 48 - Sao Paulo/SP - 04709-020
Country [1] 4214 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6705 0
Comite de Etica em pesquisa em seres humanos da Irmandade da Santa Casa de Misericordia de Sao paulo
Ethics committee address [1] 6705 0
rua Cesario Motta Junior, 112 - Sao Paulo/SP - 01221-900
Ethics committee country [1] 6705 0
Brazil
Date submitted for ethics approval [1] 6705 0
01/02/2005
Approval date [1] 6705 0
11/05/2005
Ethics approval number [1] 6705 0
065/05

Summary
Brief summary
Preterm infants used to present transitory hipertonia during their first year of life. This trial aims to study its incidence and its correlation to pre-, peri-, and post-natal factors. Study the influence in the motor evolution and check if there is a clinical standard defined that might be used for prognostic, helping to an earlier treatment, when necessary.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29399 0
Address 29399 0
Country 29399 0
Phone 29399 0
Fax 29399 0
Email 29399 0
Contact person for public queries
Name 12646 0
Walkira Basile Brunetti
Address 12646 0
rua Profa Wanda Perseguin, 48 - Sao Paulo/SP - 04709-020
Country 12646 0
Brazil
Phone 12646 0
+551194096290
Fax 12646 0
Email 12646 0
[email protected]
Contact person for scientific queries
Name 3574 0
Walkira Basile Brunetti
Address 3574 0
rua Profa Wanda Perseguin, 48 - Sao Paulo/SP - 04709-020
Country 3574 0
Brazil
Phone 3574 0
+551194096290
Fax 3574 0
Email 3574 0
[email protected]

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.