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Comparison of the Effectiveness of Prone and Supine Position on Arterial oxygen saturation , respiratory rate and heart rate in preterm newborns under nasal continuous positive airway pressure

Protocol summary

Study aim
The aim of this study is to comparison of the effectiveness of supine and prone position on Arterial oxygen saturation , respiratory rate and heart rate in preterm newborns under nasal continuous positive airway pressure
Design
This study was conducted on 62 preterm infants who were under N-CPAP and had inclusion criteria . Neonates were placed in supine position at first for 180 minute and then their position was changed into prone position for another 180 minute . During this period , heart rate, respiratory rate and arterial oxygen saturation were assessed in each neonates every 15 minutes in supine & prone position and were recorded in a questionnaire..
Settings and conduct
This study was conducted on 62 hospitalized preterm infants who were under N-CPAP in the neonatal intensive care unit of Imam Reza Hospital in Kermanshah. . Neonates were placed in supine position at first for 180 minute and then their position was changed into prone position for another 180 minute . During this period , heart rate , respiratory rate and arterial oxygen saturation were assessed in each neonates every 15 minutes in supine & prone position and were recorded in a questionnaire.
Participants/Inclusion and exclusion criteria
The inclusion criteria were : infants with gestational age of 24 to 37 weeks were diagnosed with respiratory distress syndrome under Nasal continuous positive airway pressure .The exclusion criteria were: pulmonary emphysema, pneumothorax, confirmed sepsis with positive culture , congenital heart disease, intraventricular hemorrhage , diaphragmatic hernia.
Intervention groups
62 infants who met the inclusion criteria were placed in supine position at first for 180 minute then their position was changed into prone position for another 180 minute.During this period , heart rate , respiratory rate and arterial oxygen saturation were assessed every 15 minutes .
Main outcome variables
Heart rate , respiratory rate and arterial oxygen saturation

General information

Reason for update
Acronym
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IRCT registration information
IRCT registration number: IRCT20101018004961N11
Registration date: 2018-02-16, 1396/11/27
Registration timing: retrospective

Last update: 2018-02-16, 1396/11/27
Update count: 0
Registration date
2018-02-16, 1396/11/27
Registrant information
Name
Homa Babaei
Name of organization / entity
Kermanshah University of Medical Secinces
Country
Iran (Islamic Republic of)
Phone
00988314276303 داخلی 2292
Email address
homa_babaei@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Prone and Supine Position on Arterial oxygen saturation , respiratory rate and heart rate in preterm newborns under nasal continuous positive airway pressure
Public title
Effects of Position on Arterial oxygen saturation , respiratory rate and heart rate in preterm newborns under nasal continuous positive airway pressure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
neonates with gestational age between 24 to 37 weeks respiratory distress syndrome under Continiuos positive airway pressure through the Nasal CPAP
Exclusion criteria:
congenital heart disease intraventricular hemorrhage diaphragmatic hernia pulmonary emphysema pneumothorax sepsis confirmed by positive culture vital signs instability apnea
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Blvd
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2014-11-11, 1393/08/20
Ethics committee reference number
kums.rec.1394.514

Health conditions studied

1

Description of health condition studied
Preterm newborn
ICD-10 code
P07.30
ICD-10 code description
Preterm newborn, unspecified weeks of gestation

Primary outcomes

1

Description
Arterial oxygen saturation
Timepoint
Every 15 minutes and totally 180 minutes in every position
Method of measurement
By pulseoximetry

Secondary outcomes

1

Description
Respiratory rate
Timepoint
Every 15 minutes and totally 180 minute in every position
Method of measurement
By observing the occurrence of breaths

2

Description
Heart rate
Timepoint
Every 15 minutes and totally 180 minute in every position
Method of measurement
By pulse oximeter

Intervention groups

1

Description
Intervention group: 62 infants who met the inclusion criteria were placed in supine position at first for 180 minutes and during this period , heart rate , respiratory rate and arterial oxygen saturation were assessed every 15 minutes .
Category
Other

2

Description
Intervention group: 62 infants who met the inclusion criteria were placed in prone position for 180 minutes and during this period , heart rate ,, respiratory rate and arterial oxygen saturation were assessed every 15 minutes .
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital, Kermanshah University of Medical Sciences
Full name of responsible person
DR Behzad Solimani
Street address
Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6305
Email
drbehzad66@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Deputy of Research, number2 building ,Beheshti Blvd
City
kermanshah
Province
Kermanshah
Postal code
671441533
Phone
+98 83 3838 4185
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Homa Babaei
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Parastar BLVD
City
kermanshah
Province
Kermanshah
Postal code
671441533
Phone
+98 83 3427 6305
Email
Homa_babaei@kums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Homa Babaei
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
parastar BLVD
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6305
Email
Homa_babaei@kums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr homababaei
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Parastar BLVD
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6305
Email
Homa_babaei@KUMS.AC.IR

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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