Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000398202
Ethics application status
Approved
Date submitted
12/05/2009
Date registered
2/06/2009
Date last updated
2/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the effects of the Test of Infant Motor Performance (TIMP) on motor performance in premature newborns.
Scientific title
Assessing the effects of the Test of Infant Motor Performance (TIMP) on motor performance in premature newborns.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
premature newborns 4764 0
Condition category
Condition code
Physical Medicine / Rehabilitation 237104 237104 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Test of Infant Motor Performance (TIMP) consists in items have been shown to reflect the movement demands experienced by infants in naturalistic interactions with caregivers such as bathing, dressing and play. It is a test of posture and movement in infants by 42 items. The test includes a rattle, squeaky toy, bright red ball. The test consists in head control with lift the head briefly when held upright/right the head when tilted laterally in the upright position/lift the head to 45 degrees in prone; items to trunk control - push up to sitting from sidelying/rotate the trunk to turn to sidelying; responses to visual or auditory stimuli -turning the head to find a sound in prone/turning the head from side to side to follow a moving ball in supine; selectively move the ankles, fingers, hand to reach toward objects.
Intervention code [1] 4543 0
Early detection / Screening
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5934 0
motor development upon hospital discharge by Test of Infant Motor Performance (TIMP)
Timepoint [1] 5934 0
when discharge from hospital
Secondary outcome [1] 242029 0
motor development in first year of life by TIMP. Motor development : measuring change over time the sensitive to change with maturation, discriminate among infants with differing degrees of risk for poor motor outcome and prdict with a high degree of accuracy motor performance.
Timepoint [1] 242029 0
measured when infants are at 12 months of age.

Eligibility
Key inclusion criteria
premature stable newborn clinically with spontaneous breathing and age gestacional corrected of up to 120 days.
Minimum age
1 Days
Maximum age
120 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
newborns with congenital malformations, mechanical ventilation or another ventilation support.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1759 0
Brazil
State/province [1] 1759 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 4952 0
Hospital
Name [1] 4952 0
Hospital das Clinicas
Country [1] 4952 0
Brazil
Primary sponsor type
Hospital
Name
Hospital das Clinicas
Address
Av Dr Eneas Carvalho de Aguiar,647
Sao Paulo 05403-000
Country
Brazil
Secondary sponsor category [1] 4470 0
None
Name [1] 4470 0
Address [1] 4470 0
Country [1] 4470 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7049 0
Comite de pesquisa e etica do hospital das Clinicas da Faculdade de Medicina da Usp
Ethics committee address [1] 7049 0
Av Dr Eneas Carvalho de Aguiar,647
Sao Paulo 05403-000
Ethics committee country [1] 7049 0
Brazil
Date submitted for ethics approval [1] 7049 0
05/06/2007
Approval date [1] 7049 0
24/10/2007
Ethics approval number [1] 7049 0
0812/07

Summary
Brief summary
The study consisted of the evaluation of the motor performance through the Test of Infant Motor Performance (TIMP), being applied by 1 trained physiotherapist, of discharge hospital. The analysis of the results was carried out through measures descriptive and measured of accuracy. 69 premature newborns were studied with age gestacional (AG) 32,61+/-2,69 weeks and birth weight 1207,00+/-380,14 g with predominance of the masculine sex (62 %). Of the studied population 56 newborns presented punctuation on the average, 7 presented punctuation below the average and 6 presented scores very much below the average. The newborns with punctuation inside the average they presented AG 34,44+/-0,59 weeks, birth weight of birth 1355,50+/-294,26 g and remained on average 11,22+/-7,07 days in oxygen support. The newborns that obtained performance below the average they presented AG 32,00+/-2,59 weeks, birth weight 1180,00+/-334,16 g and remained 8,20+/-4,24 days under mechanical ventilation (VM); the newborns with punctuation very much below the average they presented AG 28,76+/-2,54 weeks, birth weigh 830,00+/-332,06 g and they remained on average 42,50+/-18,93 days in VM. The values of sensibility was 54,5 % , 71,4 % especificity and values predict positive and negative of 75 % and 100 %. The premature newborns that presented worse motor performance were those who remained in support ventilatório prolonged.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29598 0
Address 29598 0
Country 29598 0
Phone 29598 0
Fax 29598 0
Email 29598 0
Contact person for public queries
Name 12845 0
Carla Marques Nicolau
Address 12845 0
Av Dr Eneas Carvalho de aguiar, 647
Sao Paulo 05403-000
Country 12845 0
Brazil
Phone 12845 0
55 (11) 30698558
Fax 12845 0
55 (11) 30696081
Email 12845 0
carla.nicolau@icr.usp.br
Contact person for scientific queries
Name 3773 0
Carla Marques Nicolau
Address 3773 0
Av Dr Eneas Carvalho de Aguiar,647
Sao Paulo 05403-000
Country 3773 0
Brazil
Phone 3773 0
55 (11)30698558
Fax 3773 0
55 (11)30696081
Email 3773 0
carla.nicolau@icr.usp.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
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Documents added automatically
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