The Effect of Oral massage and Non Nutritive Sucking on Independent Oral Feeding Performance in Preterm Infants Hospitalized in NICU of Tabriz Al-Zahra hospital
The Objective of this one blinded randomized clinical trial is to compare two methods of oral massage and non nutritive sucking on independent oral feeding performance of preterm infants hospitalized in NICU. After having parental informed consent, 81 infants who are eligible will be randomly allocated into the following two intervention groups ( oral massage, non nutritive sucking) and control group. Newborns in oral massage group were received pri and intraoral massage at least for 10 days, each time for 10 minutes twice daily by a one of nurse researcher. Newborns in non nutritive sucking group were received sucking of researcher or mother thumb at least for10 days, each time for 5 minutes four times daily before gavages. Newborns in control group receive routine care. After 10 days, by visit of neonatologist were started oral feeding. Infant's behavioral state, the ability to maintain physiologic stability, time of attaining to independent oral feeding, oral feeding frequency, oral feeding duration and duration of hospitalization is assessed. A criterion for independent oral feeding is 8 times a day oral feeding.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105304613N7
Registration date:2012-06-10, 1391/03/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-10, 1391/03/21
Registrant information
Name
Sousan Valizadeh Dehkharghani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
009804134751706- 34796770
Email address
valizades@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2012-09-18, 1391/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Oral massage and Non Nutritive Sucking on Independent Oral Feeding Performance in Preterm Infants Hospitalized in NICU of Tabriz Al-Zahra hospital
Public title
The Effect of Oral massage and Non Nutritive Sucking on Independent Oral Feeding Performance in Preterm Infants Hospitalized in NICU of Tabriz Al-Zahra Hospital
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria:28-32 weeks gestation age, have Stability of physiological , doesn’t present illness and congenital abnormalities, especially in the jaw, mouth and palate as well as heart and lung disease are not serious, not be NPO and receiving full tube feeding.
Exclusion Criteria: If the diagnosis of neuromuscular problems, cardiovascular disease and congenital anomalies in infants or being NPO during of study or having effective nutritive sucking in first 5 days of intervention, infants will be excluded.
Age
From 28 years old to 32 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Ethics committee, Third Floor, Building 2, Tabriz University of Medical Sciences, ,Department of Research Deputy, Golgasht St,Tabriz .
City
Tabriz
Postal code
Approval date
2011-07-25, 1390/05/03
Ethics committee reference number
5/4/3641
Health conditions studied
1
Description of health condition studied
Other preterm infants
ICD-10 code
P07.3
ICD-10 code description
28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation.
Primary outcomes
1
Description
time of attaining to independent oral feeding
Timepoint
each day to achieving independent oral feeding
Method of measurement
observation and recording
2
Description
oral feeding frequency
Timepoint
daily
Method of measurement
Observation and recording
3
Description
oral feeding duration
Timepoint
Daily
Method of measurement
Observation and recording
Secondary outcomes
1
Description
duration of hospitalization
Timepoint
after the intervention
Method of measurement
observation and recording
Intervention groups
1
Description
Newborns in oral massage group were received pri and intraoral massage at least for 10 days, each time for 10 minutes twice daily.
Category
Treatment - Other
2
Description
Newborns in non nutritive sucking group were received sucking of researcher or mother thumb at least for10 days, each time for 5 minutes four time daily before gavages.
Category
Other
3
Description
Newborns in control group receive routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Iran Aamirteimory
Street address
Educational and Therapeutic Center Al-Zahra, Baghshomal Crossroads, Artesh Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Medical Sciences of Tabriz University
Full name of responsible person
Dr Hosien Ebrahimi
Street address
Nursing & Midwifery Faculty
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Medical Sciences of Tabriz University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Iran Amirteimory
Position
Student of Master degree in Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
Nursing And Midwifery Faculty
City
Tabriz
Postal code
4419951668
Phone
+98 41 1479 0365
Fax
Email
iamirteimory@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)