Comparison of the effect two method care : prone positioning and pron positioning with chest physiotherapy on duration of intubation in premature neonate admitted in NICU in hazrat zainab hospital in shiraz-2015
This is a randomized clinical controlled trial. Goal of study: to evaluate the effect of prone positioning and prone positioning with chest physiotherapy on duration of intubation in premature neonate admitted in NICU of Hazrat Zainab hospital. After obtaining informed consent, neonates who meet inclusion criteria, are randomly assigned to three groups (two experimental groups and one control groups), the first experimental group, neonate mechanical ventilation lying prone position. Elbows bent and arms placed at the two sides of the body, while hands were placed at the two sides of head and head was placed towards ventilator tube. For the second group in addition to prone position chest physiotherapy was done every 8 hours. In control group routine care was given. In three groups HR, FIO2, O2 SAT , RR , check before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014121520316N1
Registration date:2015-02-22, 1393/12/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-22, 1393/12/03
Registrant information
Name
Susan Aduband
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3831 1814
Email address
adoband_s@sums.com
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect two method care : prone positioning and pron positioning with chest physiotherapy on duration of intubation in premature neonate admitted in NICU in hazrat zainab hospital in shiraz-2015
Public title
Comparison of the effect two method care: prone positioning and pron positioning with chest physiotherapy on duration of intubation in premature neonate
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: gestational age between 26-37 weeks; need to mechanical ventilation in 48 hours after birth; pron position of neonate with confirmation physician; no problem expect repiratory distress syndrome; all of the neonates took surfactant.
Exclusion criteria: no cardiac disorder; pulmunary hemorrhage; neuromuscular disease; pneumothorax and death.
Age
From 3 days old to 3 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
69
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of Shiraz University of Medical Sciences
Street address
Cetral Bulding of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
7115
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrom
ICD-10 code
J95-99
ICD-10 code description
Other diseases of respiratory syndrom
Primary outcomes
1
Description
Fio2
Timepoint
Eevery 1 Hour
Method of measurement
Monitoring and Arteial blood gas
2
Description
Pco2
Timepoint
Twice a day
Method of measurement
Blood gas
3
Description
Heart rate
Timepoint
Eevery 1 Hour
Method of measurement
Cardiac monitoring
4
Description
Raspiratory rate
Timepoint
Twice a day
Method of measurement
Monitoring
5
Description
O2Sat
Timepoint
Eevery 1 Hour
Method of measurement
Monitoring
Secondary outcomes
1
Description
parameters of mechanical ventilator
Timepoint
two time in day
Method of measurement
monitor of mechanical ventilator
Intervention groups
1
Description
In the control group treat according to routins.
Category
N/A
2
Description
In the experimental group who prone positioning, two small towels were rolled and placed under infants. Knees and abdomen to prevent pressure to knees and chest .in this position, elbows bent and arms placed at the two sides of the body, while hands were placed at the two sides of head and head was placed towards ventilator tube. Fio2 , HR , O2sat check every 1 hour.
Category
Prevention
3
Description
In the second experimental group who prone positioning whit chest physiotherapy, in addition to, prone position chest physiotherapy was done every 8 hours. Chest physiotherapy includes percussion and vibration. Percussion will be done with face masks, neonate. Vibration will be done with massager of face. HR, FIO2, RR, check every 1 hour.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Zainab Hospital
Full name of responsible person
MS.soltani
Street address
Defa Moghaddas square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Central Building of Shiraz University of Medical Sciences, Zand blvd.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mitra Edraki
Position
MSc of Nursing
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Nemazi square
City
Shiraz
Postal code
Phone
+98 71 3345 1978
Fax
Email
mitraedraki@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mitra Edraki
Position
MSc of Nursing
Other areas of specialty/work
Street address
College of Nursing and midwifery, Nemazi square
City
Shiraz
Postal code
Phone
+98 71 3345 1978
Fax
Email
mitraedraki@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Susan Aduband
Position
MSc of Nursing
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Nemazi square
City
Shiraz
Postal code
Phone
+98 71 3345 1978
Fax
Email
susanaduband@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)