Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000825055
Ethics application status
Approved
Date submitted
30/09/2010
Date registered
1/10/2010
Date last updated
1/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of intrinsic and extrinsic constraints on head movements during eye-head coordination in fullterm and preterm infants among 1 to 4 months
Scientific title
Influence of age and prematurity (instrinsic constraints) and body orientations (supine, semiflexion and reclined postures - extrinsic constraints) on head movements during eye-head coordination in fullterm from 1 to 4 months of age and preterm healthy infants among 1 to 4 months of corrected age measured by kinematical analysis.
Secondary ID [1] 252795 0
not applicable
Universal Trial Number (UTN)
U1111-1117-2848
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
head movements in pre-term infants 258294 0
head movements in fullterm infants 258295 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258489 258489 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All infants (fullterm and pre-term) will be evaluated in three conditions (supine, semiflexion and reclined) in every assessment (1, 2, 3 and 4 months).
The infant will be exposed in three conditions:
1) Condition supine, the chair will be positioned parallel to horizontal plane.
2) Condition semiflexion, the chair will be positioned parallel to horizontal plane and an infant pillow (25X20 cm), having a small concavity in the center, maintained the infant’s neck semiflexed to about 15 degrees. The concavity on the pillow did not restricte head movement.
3) Condition reclined, the chair will be positioned 20 degrees from the horizontal and infant’s neck remained semiflexed.
The sequence order of conditions exposure will be arranged in three predetermined groups: 1) supine-semiflexion-reclined; 2) reclined-semiflexion-supine; and 3) semiflexion-reclined-supine.
In all conditions, the infant will be presented with a black and white happy face card (10X10 cm), which will be placed in front of his/her face at eyes’ height and at a distance of 25-40 cm. The card will be moved slowly (manually, always by the same examiner) in a crosswise direction as soon as the infant had gazed it. When visual contact with the card were lost, it will be presented again, as many times as necessary, within the 2-min period determined for each condition. Visual contact during head movement will be monitored through the reflection of the card image in the infant’s pupil.
Intervention code [1] 257318 0
Treatment: Other
Comparator / control treatment
The treatment will be the same and will be compared the effects of the tratement on pre-term and term infants
Control group
Active

Outcomes
Primary outcome [1] 259324 0
median angular velocity of head movement measured by kinematical analysis and Matlab software.
Timepoint [1] 259324 0
monthly, and in each condition, from 1 to 4 months in fulltem infants and from 1 to 4 months of corrected age for pre-term infants
Primary outcome [2] 259331 0
range of motion (flexion extension, inclination and rotation) of head movement, measure by kinematica analysis and Matlab software.
Timepoint [2] 259331 0
monthly, and in each condition, from 1 to 4 months in fulltem infants and from 1 to 4 months of corrected age for pre-term infants
Secondary outcome [1] 265772 0
frequency of head movement, measured by watching the images recorded during assessment by three video cameras. These images will be watched in Dvideo software for kinematical analysis, after assessment.
Timepoint [1] 265772 0
monthly, and in each condition, from 1 to 4 months in fulltem infants and from 1 to 4 months of corrected age for pre-term infants, by quantification of frequencies observed when watching the images recorded, afer assessment. On pre-term infants, the assessment will occur in corrected ages of 1, 2, 3 e 4 months.

Eligibility
Key inclusion criteria
Twenty healthy full-term infants free from neurological or musculoeskeletal pathologies, with gestational age between 37 and 40 weeks, birth weight higher than 2.500 g, Apgar in the first minute higher than 7 and in the fifth minute higher than 9.
Twenty healthy pre-term infants free from neurological or musculoeskeletal pathologies, with gestational age between 30 and 36 weeks, birth weight adequated for gestational age, Apgar in the first minute highter than 7 and in the fifth minute higher than 9.
These convenience sample will be selected based on maternity medical records information.
Minimum age
0 Months
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) congenital defects in the central nervous system (anencephaly, spina bifida, micro / macrocephaly, hydrocephalus, among others);
2) signs of neurological damage (hypoxic-ischemic encephalopathy grades: I, II and III, intracranial hemorrhage, neonatal seizures, spasticity, abnormalities in
reflexes and hypotonia), and 3) musculoskeletal (congenital torticollis, arthrogryposis multiplex, achondroplasia), 4) diagnostic of genetic syndromes (Down syndrome or any syndrome deletion chromosome) or symptoms of withdrawal symptoms associated with maternal report of abuse of alcohol and drugs, 5) congenital infections (toxoplasmosis, rubella, cytomegalovirus, syphilis,
humam imunodeficiency virus (HIV), hepatitis A, B or C) reported by mothers whose serology, as described in the handbook
motherhood, is positive, 6) have sensory deficits (auditory and visual), detected by thorough pediatric examination performed after the birth at the Maternity and signs of retinopathy of prematurity, grade: II and III, 7) cardio-respiratory problems, 8) hyaline membrane syndrome, sepsis or whose mothers have submitted episode
pre-eclampsia or eclampsia. Will be excluded infants who do not attend for the first evaluation on the given date.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The infants will be included alternately in one of three arrangements (1) supine-semiflexion-reclined; 2) reclined-semiflexion-supine; and 3) semiflexion-reclined-supine).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The infants will be included in differents groups according to their arrival order on the first assessment day and remained in the same group in all the following assessments.
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 2942 0
Brazil
State/province [1] 2942 0
Sao Carlos

Funding & Sponsors
Funding source category [1] 257760 0
Government body
Name [1] 257760 0
Foundation for Research Support of Sao Paulo, National Council for Scientific and Technological Development
Country [1] 257760 0
Brazil
Primary sponsor type
Individual
Name
Carolina Daniel de Lima-Alvarez
Address
Rod. Washington Luis, Km 235
Sao Carlos/SP CEP: 13 560 000
Country
Brazil
Secondary sponsor category [1] 256971 0
Individual
Name [1] 256971 0
Eloisa Tudella
Address [1] 256971 0
Rod. Washington Luis, Km 235
Sao Carlos/SP CEP: 13 560 000
Country [1] 256971 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259803 0
Human Research Ethics Committee of the Federal University of Sao Carlos
Ethics committee address [1] 259803 0
Rod. Washington Luis, Km 235
Sao Carlos/SP CEP: 13 560 000
Ethics committee country [1] 259803 0
Brazil
Date submitted for ethics approval [1] 259803 0
01/06/2006
Approval date [1] 259803 0
07/12/2006
Ethics approval number [1] 259803 0
289/2006

Summary
Brief summary
The current study aim to investigate the influence of different body orientations (extrinsic constraint) on continuous (mean velocity; head range of motion: flexion-extention, inclination and rotation) and categorical (head movement frequency; head trajectory – side-to-midline, midline-to-side and side-to-side; initial head position – right, left and midline) variables of head movements in the period when head control is developing (0-4 months of age considered an intrinsic constraint) in both: fullterm and pre-term infants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31718 0
Address 31718 0
Country 31718 0
Phone 31718 0
Fax 31718 0
Email 31718 0
Contact person for public queries
Name 14965 0
Carolina Daniel de Lima-Alvarez
Address 14965 0
Rod. Washington Luis, Km 235
Sao Carlos/SP CEP: 13 560 000
Country 14965 0
Brazil
Phone 14965 0
00 55 16 3351 8407
Fax 14965 0
Email 14965 0
[email protected]
Contact person for scientific queries
Name 5893 0
Eloisa Tudella
Address 5893 0
Rod. Washington Luis, Km 235
Sao Carlos/SP CEP: 13 560 000
Country 5893 0
Brazil
Phone 5893 0
00 55 16 3351 8407
Fax 5893 0
Email 5893 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

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