Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000133033
Ethics application status
Approved
Date submitted
20/01/2010
Date registered
9/02/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Behavioral analysis of preterm neonates included in a tactile and kinesthetic stimulation program during hospitalization in preterm neonates
Scientific title
Tactile and kinesthetic stimulation program during hospitalization and behavioral analysis in preterm neonates
Secondary ID [1] 1337 0
Nil.
Secondary ID [2] 1339 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm neonates 256624 0
Condition category
Condition code
Reproductive Health and Childbirth 256792 256792 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stable preterm neonates received tactile and kinesthetic stimulation during hospitalization; by trained author and mothers. With ligth touch and arms and legs mobilization; during 5 to 15 minutes daily, since preterm was clinically stable until hospital discharge.
Intervention code [1] 255875 0
Treatment: Other
Comparator / control treatment
A control group in which no intervention was made (no treatment).
Control group
Active

Outcomes
Primary outcome [1] 257659 0
Predominance of self-regulated behavior in Behavioral Scale (adapted from Neonatal Behavioral Assessment Scale NBAS).
Timepoint [1] 257659 0
Every week, at least one week after beggining of stimulation untill hospital discharge.
Secondary outcome [1] 262939 0
Shorter duration of hospital stay.
Timepoint [1] 262939 0
After hospitalization.

Eligibility
Key inclusion criteria
Stable preterm infants weighing < 2500 grams, with no significant perinatal asphyxia.
Minimum age
31 Weeks
Maximum age
36 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Vision and/or hear disfuction; neurological problems; instable preterms; without family autorization.

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment outside Australia
Country [1] 2430 0
Brazil
State/province [1] 2430 0

Funding & Sponsors
Funding source category [1] 256358 0
University
Name [1] 256358 0
Universidade de Sao Paulo
Country [1] 256358 0
Brazil
Primary sponsor type
Government body
Name
Conselho Nacional de Desenvolvimento Cientifico e Tecnologico
Address
1721, Prof. Mello Moraes Street, Sao Paulo, Cidade Universitaria, Zip Code 055508-900
Country
Brazil
Secondary sponsor category [1] 251677 0
Individual
Name [1] 251677 0
Andreia Menandro Ferreira
Address [1] 251677 0
1539, apt 53, Conego Valadao Street, Guarulhos, Gopouva, Zip Code 07040-000
Country [1] 251677 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258434 0
Comite de Etica em Pesquisa do Hospital Universitario da Universidade de Sao Paulo
Ethics committee address [1] 258434 0
2565, Prof Lineu Prestes Streets, Sao Paulo, Cidade Universitaria, Zip Code 05508-000
Ethics committee country [1] 258434 0
Brazil
Date submitted for ethics approval [1] 258434 0
Approval date [1] 258434 0
21/11/2003
Ethics approval number [1] 258434 0
1/03/0393

Summary
Brief summary
Objective: To evaluate the effect of tactile and kinesthetic stimulation on behavioral and clinical development in preterm neonates while still in hospital. Methods: Thirty-two clinically stable preterm infants weighing < 2500 grams, with no significant perinatal asphyxia, were allocated to two groups: a control group (CG) in which no intervention was made (n=16) and a study group (SG) in which the newborn infants received tactile and kinesthetic stimulation (n=16). Data on the infants’ clinical progress were collected from medical charts and behavioral evaluations were carried out using a series of weekly, 8-minute films recorded from study admission until hospital discharge. Results: There was a trend towards a shorter duration of hospital stay, increased daily weight gain and a predominance of self-regulated behavior (regular breathing, state of alert, balanced tonus, a range of postures, coordinated movements, hand-to-face movement control, suction, grasp, support) in infants in the SG. With respect to motor control, comparative analysis of postconceptional ages according to age-bracket (I – 31-33 weeks 6/7; II – 34-36 weeks 6/7; and III – 37-39 weeks 6/7) revealed balanced tonus and coordinate voluntary movements in all three periods, a longer time spent in a range of postures (age bracket I) or in flexion (age bracket II) and more regular breathing in age bracket I in the SG. Conclusion: In hospital tactile and kinesthetic stimulation was shown to have a positive effect, contributing towards adjustment and self-regulation of behavior in the preterm newborn infant.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30738 0
Address 30738 0
Country 30738 0
Phone 30738 0
Fax 30738 0
Email 30738 0
Contact person for public queries
Name 13985 0
Andreia Menandro Ferreira
Address 13985 0
1539, apt 53, Conego Valadao Streets, Guarulhos, Gopouva, Zip Code 07040-000
Country 13985 0
Brazil
Phone 13985 0
+55 (11) 2422-7034; +55 (11) 9309-2915
Fax 13985 0
Email 13985 0
[email protected]
Contact person for scientific queries
Name 4913 0
Andreia Menandro Ferreira
Address 4913 0
1539, apt 53, Conego Valadao Streets, Guarulhos, Gopouva, Zip Code 07040-000
Country 4913 0
Brazil
Phone 4913 0
+55 (11) 2422-7034; +55 (11) 9309-2915
Fax 4913 0
Email 4913 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
SourceTitleYear of PublicationDOI
Dimensions AIAnálise comportamental de recém-nascidos pré-termos incluídos em um programa de estimulação tátil-cinestésica durante a internação hospitalar2010https://doi.org/10.1590/s1413-35552010005000002
N.B. These documents automatically identified may not have been verified by the study sponsor.