To investigate the effect of using pacifier and mother’s finger, two ways of non-nutritive sucking, during gavage on physiological parameters in preterm neonates.
It was a quasi-experimental study which were done in university hospitals having NICU i Tehran, Iran. Sampling method was continuous. Informed consent was obtained from parents after the nature of study was explained. Due to the number of samples required, infants were enrolled. Once the infant was getting out of NPO, gavage started with breast milk. All infants were in stable and awake state. NNS with mother's finger ( already receiving instructions about hand-wash) putting on hypoallergenic disposable gloves started; before, during and after feeding with NGT, on a certain time. Then pulse rate and o2 saturation were recorded of monitor connected to infant. For next time feeding infant received NNS with pacifier and the other feeding gavage were done without any interventions. This recording continued for 4 days. NNS started 5 min before feeding until 5 min after feeding. For all samples breast-milk was used for feeding.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052234086N1
Registration date:2017-06-07, 1396/03/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-07, 1396/03/17
Registrant information
Name
Teni Javadian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2885
Email address
javadianteni@gmail.com
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To investigate the effect of using pacifier and mother’s finger, two ways of non-nutritive sucking, during gavage on physiological parameters in preterm neonates.
Public title
To investigate the effect of using pacifier and mother's finger on physiological parameters in preterms.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: gestational age of birth 34 to 37 weeks; stable hemodynamic state; breastfeeding; no need to respiratory support; not having apnea events; not receiving analgesic drugs.
Exclusion criteria: having metabolic disorders; genetic syndromes; abnormalities in mouth movements; cognitive disorders; neurological disorders; oral and palatal disorders; sudden changes in physiological parameters; change of milk type.
Age
From 1 day old to 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Approval date
2016-08-08, 1395/05/18
Ethics committee reference number
IR.IUMS.REC 1395.9311451003
Health conditions studied
1
Description of health condition studied
Effect of non nutritive sucking on physiological parameters
ICD-10 code
PO5-PO8
ICD-10 code description
Disorders of newborn related to length of gestation and fetal growth
Primary outcomes
1
Description
Heart rate
Timepoint
5 min before gavage, during gavage, 5 min after gavage
Method of measurement
Monitoring
2
Description
Oxygen saturation
Timepoint
5 min before gavage, during gavage, 5 min after gavage
Method of measurement
Monitoring
Secondary outcomes
1
Description
Tachycardia
Timepoint
During intervention
Method of measurement
Monitoring
2
Description
Reduction in oxygen saturation
Timepoint
During intervention
Method of measurement
Monitoring
Intervention groups
1
Description
This intervention is on preterm infants; sing mother's finger and pacifier during feeding with NGTube and during third feeding no intervention is used for infant.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar hospital affiliated to Iran University of Medical Sciences
Full name of responsible person
Dr. Sorour Parvizy
Street address
Ali Asghar hospital, Dastgerdi st.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ms. Sorour Parvizy
Street address
Nursing Faculty, Yasemi St., Vali e Asr St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Sorour Parvizy
Position
PhD / nursing education
Other areas of specialty/work
Street address
Faculty of Nursing, Yasemi St. Vali Asr St.
City
Tehran
Postal code
Phone
+98 21 8888 2058
Fax
Email
s_parvizy@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Teni Javadian
Position
MSc student of NICU nursing
Other areas of specialty/work
Street address
Faculty of Nursing, Yasemi St., Vali Asr St.
City
Tehran
Postal code
Phone
+98 21 8883 4062
Fax
Email
javadianteni@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Teni Javadian
Position
MSc student of NICU nursing
Other areas of specialty/work
Street address
Faculty of Nursing, Yasemi St. Vali Asr St.
City
Tehran
Postal code
Phone
+98 21 8883 4062
Fax
Email
javadianteni@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)