This is a cross sectional clinical trial in which premature newborns with the gestational age between 32 to 36 weeks and birth age of 2 days to 4 weeks admitted to Neonatal Intensive Care Unit will be placed in the two groups with paired block. In the first stage, after selecting the samples, the intervention and control groups will be selected and in the second stage the two groups will be switched. To do the work, at first each newborn will be positioned laterally for 15 minutes and then placed in prone or supine position for 3 hours. After 3 hours, the newborn will be positioned laterally fir 15 minutes again and then placed in the opposite position for 3 hours. For each newborn arterial blood oxygen concentration, heart rate, respiratory rate and body temperature will be documented every 15 minutes for 3 hours. The main goal is determining the effect of two prone and supine positions on premature newborns’ blood oxygen concentration and vital signs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041633471N1
Registration date:2017-09-27, 1396/07/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-27, 1396/07/05
Registrant information
Name
Hamid Torabian
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3293 6248
Email address
h.torabian@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2017-09-16, 1396/06/25
Expected recruitment end date
2017-10-17, 1396/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of prone and supine positions on arterial blood oxygen saturation and vital signs of premature newborn
Public title
Comparing the effect of prone and supine positions on arterial blood oxygen saturation and vital signs of premature newborn
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: gestational age between 32-36 weeks; birth age of 2 days to 4 weeks; weight at least 1000 grams; not using ventilator; spontaneous breathing; maximum oxygen concentration of 5 liter/minute if using oxygen by hood or incubator; free of congenital anomalies, free of active bleeding; not having blood problems; methemoglobinemia; carboxyhemoglobinemia; hemoglobin greater than 9 gr/dl; not using narcotics, corticosteroids, and surfactant
Exclusion criteria: connecting to ventilator; infecting with pneumothorax; death; parental dissatisfaction with continuing the work; need to perform CPR
Age
From 2 days old to 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
In this study, after selecting the samples based on inclusion criteria, the samples will be placed in the two intervention and control groups with paired block randomization. In addition to arterial blood oxygen concentration, at the same time premature newborns` vital signs such as respiratory rate, heart rate and body temperature will be monitored and documented.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Deputy of research and technology;Third Floor;Imam Musa Kazim Building;Academic Complex of the Payamber ; Basij Square;Arak;Markazi Province
City
Arak
Postal code
Approval date
2017-03-13, 1395/12/23
Ethics committee reference number
IR.ARAKMU.REC.1395.448
Health conditions studied
1
Description of health condition studied
Sleep state to the abdomen and back
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Arterial Blood Oxygen Saturation
Timepoint
Every 15 minutes to 3 Hours
Method of measurement
Puls Oximiter
2
Description
Heart Rate
Timepoint
Every 15 minutes to 3 hours
Method of measurement
Puls Oximiter
3
Description
Breath Rate
Timepoint
Every 15 minutes to 3 hours
Method of measurement
Chest lead
4
Description
Temperature
Timepoint
Every 15 minutes to 3 hours
Method of measurement
SkinThermometer
Secondary outcomes
empty
Intervention groups
1
Description
Second Intervention:sleep newborn on supine position for 3 hours
Category
Other
2
Description
First intervention: Sleep newborn on prone position for 3 hours
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Hamid Torabian
Street address
Amir Kabir Hospital,Parastar Sq, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Arak University of Medical Sciences
Full name of responsible person
Ali Arash Anoshiravani
Street address
Deputy of research and technology,Third Floor,Imam Musa Kazim Building,Academic Complex of the Payamber , Basij Square,Arak;Markazi Province
City
Arak
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,Arak 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
Vice chancellor for research,Arak University of Medical Sciences
Full name of responsible person
Ali Arash Anoshiravani
Position
Blood specialist and oncology
Other areas of specialty/work
Street address
Deputy of research and technology,Third Floor,Imam Musa Kazim Building,Academic Complex of the Payamber , Basij Square,Arak;Markazi Province
City
Arak
Postal code
Phone
+98 86 3417 3638
Fax
+98 86 3417 3639
Email
Research@arakmu.ac.ir
Web page address
www.arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Arak University of Medical Sciences
Full name of responsible person
Doc Sharareh khosravi
Position
phD nursing
Other areas of specialty/work
Street address
Blue Bal,School of Nursing and Midwifery , Academic Complex of Prophet Muhammad (PBUH, Sardasht, Basij Sq, Arak
City
Arak
Postal code
Phone
+98 86 3417 3503
Fax
Email
shararehkh2011@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Arak University of Medical Sciences
Full name of responsible person
Hamid Torabian
Position
MSN
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 25 3291 1958
Fax
Email
h.torabian@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)