Comparison of prone and supine position on oxygenation of Nasal CPAP treating premature infants with respiratory distress syndrome in Tabriz Alzahra hospital, 2010.
The goal of this study is comparison of prone and supine positions on oxygenation of Nasal CPAP treating premature infants. The study population of this study includes 29-34 weeks gestation premature infants, who have respiratory distress syndrome and are under N-CPAP treatment. Participated Infants randomly divided to 2 groups. First group at first placed in supine and then prone position and the second group placed vice versa. Then SatO2, Fio2, RR and HR assessed every 10 minutes for totally 30 minutes in each position and documented in questionnaire. After every change position, there were 15 minutes time distance for infant's stabling in new position that is called washout period and after passing this time measure and document of parameters is done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011135168N1
Registration date:2011-06-12, 1390/03/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-12, 1390/03/22
Registrant information
Name
Maliheh Assadollahi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
assadollahim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research ,Tabriz University of Medical Sciences
Expected recruitment start date
2010-07-01, 1389/04/10
Expected recruitment end date
2010-10-02, 1389/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of prone and supine position on oxygenation of Nasal CPAP treating premature infants with respiratory distress syndrome in Tabriz Alzahra hospital, 2010.
Public title
Effect of supine and prone positions on oxygenation of premature infants with respiratory distress syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 29-34 weeks gestational age, Existence of respiratory distress requires to use of Nasal CPAP, prescribed PEEP amount equal 5 or 6 cmH2o, The maximum time for receiving CPAP three days, Being NPO, inexistence of congenital heart diseases in infants, inexistence congenital structural defects in respiratory system, not having any physical deformity which be obstacle for change position,1 passing at least 6 hours from receiving surfactant, not caring out invasive procedures such as IV line insertion or blood sampling during the parameters measure.
Exclusion criteria: Enhancement of respiratory distress and need to intubation, catching pneumothorax and need to chest tube insertion.
Age
From 28 years old to 34 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Deputy of Research in Medical Sciences of Tabriz University
City
Tabriz
Postal code
Approval date
2010-09-10, 1389/06/19
Ethics committee reference number
8936
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress of newborn
Primary outcomes
1
Description
arterial oxygen saturation (SatO2)
Timepoint
every 10 minutes and totally 30 minutes in every position
Method of measurement
pulse oximeter and the concentration of received oxygen (FiO2) measured by using oxygen/air Blender
2
Description
heart rate (HR)
Timepoint
every 10 minutes and totally 30 minutes in every position
Method of measurement
pulse oximeter and the concentration of received oxygen (FiO2) measured by using oxygen/air Blender
Secondary outcomes
1
Description
Enhancement of arterial oxygen saturation and reduction of concentration of received oxygen of Nasal CPAP treating premature infant's in Prone position
Timepoint
every 10 minutes and totally 30 minutes in every position
Method of measurement
By using the Masimo Set pulse oximeter structured by SAADAT company and Medin air/oxygen Blender structured by Innovation company
Intervention groups
1
Description
Infant randomly placed in supine or prone position (as first position) and left for 15 minutes to get stable in this situation and no procedure carried out in this period. After 15 minutes arterial oxygen saturation (SatO2) and heart rate (HR) measured by using the pulse oximeter and the concentration of received oxygen (FiO2) measured by using oxygen/air Blender and documented in questionnaire. Then number of infant's respiration (RR) counted by researcher within one minute, and documented in questionnaire