Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000665033
Ethics application status
Approved
Date submitted
24/07/2010
Date registered
16/08/2010
Date last updated
16/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Impact of oral motor stimulation on sucking skill maturation assessed by Digital Cervical Auscultation in preterm infants
Scientific title
Assessment of sucking skill maturation by digital cervical auscultation following oral motor stimulation compared with placebo in preterm infants.
Secondary ID [1] 252292 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm infants with immature pattern of oral skills for feeding performance 257810 0
Condition category
Condition code
Reproductive Health and Childbirth 257979 257979 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The oral stimulation will be performed by an experienced Speech Therapist and will be consisted of 15 minutes of stimulation delivered once a day 30 minutes before gavage, for the last 10 consecutive days of the period of gavage. All infants will be in their incubators, held in a supported, flexed position. The following movements will be made with the Speech Therapist’s index finger: 1) finger at the base of the nose and moved toward the ear and moved down toward the corner of the lip; 2) finger at the corner of the upper lip and moved in a circular motion from the corner toward the center; 3) finger at the corner of the lower lip and moved away in a circular motion; 4) finger in the center of the lip and stretched down toward the midline; 5) finger in the center of the gum, pressured slowly towards the back of the mouth; 6) finger at inner corner of the lips, compressing the tissue, moving back toward the molars and returning to corner of the lip; 7) finger at the level of the molar between the side blade of the tongue and the lower gum, moving the finger towards midline, pushing the tongue towards the opposite direction; 8) finger at the midline, center of the palate, gently stroking the palate to elicit a suck.
Intervention code [1] 256870 0
Diagnosis / Prognosis
Intervention code [2] 256871 0
Rehabilitation
Comparator / control treatment
The SHAM stimulation will be made the same researcher placing her hands inside the incubator for 15 minutes without touching the infant.
Control group
Placebo

Outcomes
Primary outcome [1] 258845 0
Primary outcome: achievement of effective oral feeding
Timepoint [1] 258845 0
Timepoint: cervical digital auscultation assessed before oral stimulation and at achievement of effective oral feeding
Secondary outcome [1] 264962 0
Secondary outcome: mature pattern of sucking skills
Timepoint [1] 264962 0
Timepoint: cervical digital auscultation assessed before oral stimulation and at achievement of effective oral feeding

Eligibility
Key inclusion criteria
Preterm infants at current gestational between 34 and 36 weeks and weight above 1500g
Minimum age
34 Weeks
Maximum age
36 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Preterms infants with any condition related to swallowing impairment and / or any of the following: intracranial hemorrhage, perinatal asphyxia, bronchopulmonary dysplasia, growth retardation, intrauterine severe jaundice, genetic syndrome, neurological disease of any etiology, craniofacial malformation, tracheostomy, history of any structural malformations suggestive of swallowing problem.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software will be used .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
No stratified allocation will be used.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment outside Australia
Country [1] 2781 0
Brazil
State/province [1] 2781 0
Rio Grande do Sul

Funding & Sponsors
Funding source category [1] 257331 0
Self funded/Unfunded
Name [1] 257331 0
Country [1] 257331 0
Primary sponsor type
Individual
Name
Helena A. S. Goldani
Address
Rua Ramiro Barcelos 2350
Porto Alegre - RS
CEP:90035-150
Country
Brazil
Secondary sponsor category [1] 256574 0
Individual
Name [1] 256574 0
Caroline Silveira
Address [1] 256574 0
Rua Dr Otavio Santos 111/508
Porto Alegre - RS
CEP: 91210-001
Country [1] 256574 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259356 0
Comite de Etica do Grupo Hospitalar Conceicao
Ethics committee address [1] 259356 0
Rua Francisco Trein, 596
Porto Alegre - RS
Brasil
CEP: 91350-200
Ethics committee country [1] 259356 0
Date submitted for ethics approval [1] 259356 0
Approval date [1] 259356 0
24/03/2010
Ethics approval number [1] 259356 0
1/05/0195

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31431 0
Address 31431 0
Country 31431 0
Phone 31431 0
Fax 31431 0
Email 31431 0
Contact person for public queries
Name 14678 0
Caroline Silveira da Silva
Address 14678 0
Rua Dr Otavio Santos 111/508
Porto Alegre - RS
CEP: 91210-001
Country 14678 0
Brazil
Phone 14678 0
+55 51 91482218
Fax 14678 0
Email 14678 0
carolsfono@yahoo.com
Contact person for scientific queries
Name 5606 0
Helena A. S. Goldani
Address 5606 0
Rua Ramiro Barcelos 2350
Porto Alegre-RS
CEP: 90035-901
Country 5606 0
Brazil
Phone 5606 0
+55 51 3359 8293
Fax 5606 0
Email 5606 0
hgoldani@hcpa.ufrgs.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.