The effect of oral massage on the time of acquisition independent sucking in preterm infants
Design
Clinical trial with control group
Settings and conduct
This study is carried out at the rehabilitation center of Birjand University of Medical Sciences. Participating infants fall into two groups. One group receives a Beckmann massage program and the other group receives similar movements. In fact, the second group does not receive intervention and their parents do not know about it. Then, the time to acquisition independent sucking are counted with the condition of 10 times independent sucking and feeding per day, from the beginning of the study.
Participants/Inclusion and exclusion criteria
Premature infants of 28 to 32 weeks of age with no respiratory problems, cleft palate and other facial anomalies who have stable vital condition and continue to receive intubation for at least one month after birth.
Intervention groups
Babies fall into two groups. One group receives a Beckmann massage program and the other group receives similar massage like movements
Main outcome variables
Possible changes may include decreasing intubation time, accelerating the acquisition of independent sucking time in neonates, increasing neonatal weight gain, as well as increasing coordination of swallowing and breathing and muscle strength during sucking.
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20200105046018N1
Registration date:2020-01-14, 1398/10/24
Registration timing:registered_while_recruiting
Last update:2020-01-14, 1398/10/24
Update count:0
Registration date
2020-01-14, 1398/10/24
Registrant information
Name
Elahe Farmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1400
Email address
elahe.farmani@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral massage on independent sucking time in premature infants
Public title
sucking in preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Disability in independent sucking and feeding through intubation for at least one month after birth
تولد با سن جنینی بین 28 تا 32 هفته
Exclusion criteria:
The presence of oral maxillary anomalies and cleft palate
Respiratory problems and unstable vital conditions
Age
From 15 days old to 180 days old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Infants fall into two groups.The beckmann program massage is performed for one group and the control group observes similar movements to their infant. In fact, this group does not receive sensory motor stimulation and is intended to prevent the mother from imitating.
Placebo
Used
Assignment
Other
Other design features
Babies fall into two groups. One group receives a Beckmann massage program and the other group receives massage-like movements.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghafari street
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2019-10-14, 1398/07/22
Ethics committee reference number
22/07/1398
Health conditions studied
1
Description of health condition studied
sucking in preterm infants
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
time of acquisition independent sucking
Timepoint
Once a week, one week from the start of the program
Method of measurement
Ability to suck ten times independently of mother's breast or glass
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group of infants receive a Beckmann massage program once a day in the rehabilitation clinic setting and twice at home by the mother.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
clinic of rehabilitation Birjand University of medical science (Hakim)
Full name of responsible person
Elahe Farmani
Street address
Shahed 1. corner of sardaran shahid
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3241 1671
Email
elahe.farmani@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Ebrahim Miri
Street address
ghafari st
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1400
Fax
+98 56 3238 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Elahe Farmani
Position
instructor of speech and language pathology
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Ghafari st. Birjand University of medical science
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1400
Email
elahe.farmani@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Elahe Farmani
Position
instructor of speech therapy
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Ghafari st
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1400
Email
elahe.farmani@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Elahe Farmani
Position
instructor of speech therapy
Latest degree
Master
Other areas of specialty/work
Speech therapy
Street address
Ghafari st
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1400
Email
elahe.farmani@bums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as information on when to suck, can be shared
When the data will become available and for how long
from 03/2020
To whom data/document is available
Researchers working in universities and rehabilitation centers
Under which criteria data/document could be used
Feel free to carry out similar or complementary studies
From where data/document is obtainable
Email: elahe.farmani@bums.ac.ir
What processes are involved for a request to access data/document
Information will be transmitted within 15 days after receiving the email.