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Effect of Non Nutritive Sucking on Oxygen Saturations of neonates under continuous distending pressure by Nasal Continuous Positive Airway Pressure.

Protocol summary

Summary
This Quasi Experimental study is done to reduce The Mouth Leak and Increase Oxygen Saturation Of The neonates under continuous distending pressure by Nasal Continuous Positive Air way Pressure. . Inclusion criteria included: gestational age between 28 to 37 weeks, the risk of respiratory distress requiring NCPAP therapy and infants who require respiratory support through NCPAP in the first 48 hours after birth. Exclusion criteria included: congenital heart disease , having facial anomalies , increased need for oxygen therapy .The Study Is Done on 25 infants hospitalized in the neonatal intensive care unit of Ayatollah Rouhani hospital and Babol clinics of Babol University of Medical Sciences. Before conducting the study, the procedure was explained to the parents of these babies and if they wish to participate , the investigation will be done. parameters such as babies arterial oxygen saturation, heart rate and respiratory rate (5 times every 15 minutes at 3 o'clock in the afternoon during an hour before non-nutritive sucking implementation; minutes: 0, 15, 30, 45 and 60 before the run) is measured and recorded. In the next stage, after the implementation of non-nutritive sucking, at 4 pm, infants arterial oxygen saturation, heart rate and respiratory rate in minutes: 5, 15, 30, 45 and 60 will be measured and recorded. None of the infants is undergone painful procedures during the review and will not be manipulated. The mean values of arterial oxygen saturation, heart rate and respiratory rate before and after the implementation of non-nutritive sucking will be compared. We use standard and age-appropriate infant pacifiers to perform procedure. we use monitoring device of company SAADAT, model NOVIN S 1800, which is made in Iran to record values of arterial oxygen saturation and heart rate. Also, in order to check breathing, respiratory rate of infants will be measured and recorded by researcher in completed 60 seconds in the minutes noted. After reaching a sufficient sample size, comparing variables including arterial oxygen saturation, heart rate and respiratory rate before and after the implementation of non-nutritive sucking will be done.

General information

Acronym
CPAP - NNS - RDS
IRCT registration information
IRCT registration number: IRCT2014051717710N1
Registration date: 2014-06-16, 1393/03/26
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-06-16, 1393/03/26
Registrant information
Name
Zoya Hadi Nezhad Zarrin Abadi
Name of organization / entity
Babol University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 15 1328 1482
Email address
mahmadpour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University Of Medical Science
Expected recruitment start date
2014-01-17, 1392/10/27
Expected recruitment end date
2014-06-17, 1393/03/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Non Nutritive Sucking on Oxygen Saturations of neonates under continuous distending pressure by Nasal Continuous Positive Airway Pressure.
Public title
Effects of Non-Nutritive Sucking on infants oxygenation .
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included: gestational age between 28 to 37 weeks, the risk of respiratory distress requiring NCPAP Therapy and infants who require respiratory support through NCPAP the first 48 hours after birth. Exclusion criteria included: congenital heart disease , having facial anomalies , increased need for oxygen , inability to maintain oxygenation , increased arterial carbon dioxide pressure exceeding 60 mm Hg or PH ≤ 7.25, drug abuse of mother, drugs and diseases affecting the heart rate , arterial oxygen saturation percentage and respiratory rate of baby.
Age
To 2 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 25
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
Ethic Committee Of Babol University Of Medical Science
Street address
Ganj Afrooz Street -Babol -Mazandaran
City
Babol
Postal code
4717641367
Approval date
2013-12-21, 1392/09/30
Ethics committee reference number
3480/30/ژ/پ

Health conditions studied

1

Description of health condition studied
Respiratory Distress Of Neonates
ICD-10 code
P22
ICD-10 code description
Respiratory distress syndrome of newborn

Primary outcomes

1

Description
Oxygen Saturation Percentage
Timepoint
minutes: 0, 15, 30, 45 and 60 before the run And minutes: 5, 15, 30, 45 and 60 After Implementation
Method of measurement
Pulse Oximeter

Secondary outcomes

1

Description
Heart Rate Of Neonates
Timepoint
minutes: 0, 15, 30, 45 and 60 before the run And minutes: 5, 15, 30, 45 and 60 After Implementation
Method of measurement
SAADAT Monitoring

2

Description
Respiratory Rate Of Neonates
Timepoint
minutes: 0, 15, 30, 45 and 60 before the run And minutes: 5, 15, 30, 45 and 60 After Implementation
Method of measurement
by researcher in completed 60 seconds in the minutes noted.

Intervention groups

1

Description
implementation of non-nutritive sucking will be done at 4 pm for 1 hour. We use standard and age-appropriate infant pacifiers to perform procedure.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Dr.Mousa Ahmad Pour
Street address
Ganj Afrooz Street , Babol ,Mazandaran
City
Babol

2

Recruitment center
Name of recruitment center
Babol Clinic
Full name of responsible person
Dr.Yaddollah Zahed Pasha
Street address
Ferdos Square, Babol ,Mazandaran
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Babol University Of Science
Full name of responsible person
Dr.Mousa Ahmad Pour
Street address
Ganj Afruz Street, Babol, Mazandaran
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Babol University Of Science
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
Babol University Of Medical Science
Full name of responsible person
Zoya Hadi Nezhad Zarrin Abadi
Position
Nursing Student(Master)
Other areas of specialty/work
Street address
Juibar Street, Sari, Mazandaran
City
Sari
Postal code
4843183736
Phone
+98 15 1328 1482
Fax
+98 15 1226 9957
Email
zoya.hadian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University Of Medical Science
Full name of responsible person
Dr.Mousa Ahmad Pour
Position
Assistant professor of Pediatrics & Neonatology-Neonatologist
Other areas of specialty/work
Street address
Ganj Afruz Street , Babol, Mazandaran
City
Babol
Postal code
4717647745
Phone
+98 11 1324 0973
Fax
+98 11 1324 4592
Email
m.ahmadpour@mubabol.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University Of Medical Science
Full name of responsible person
Zoya Hadi Nezhad Zarrin ABADI
Position
Nursing Student/employer
Other areas of specialty/work
Street address
Juibar Street, Sari, Mazandaran
City
Sari
Postal code
4843183736
Phone
+98 15 1328 1482
Fax
+98 15 1226 9957
Email
zoya.hadian@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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