The comparison of prone and supine position’s effect, on the oxygenation and the vital signs in the preterm neonates who are under the nasal continuous positive air way pressure
In a cross over clinical trial ,we investigated effects of different positioning in 30neonates28 to 37 weeks' gestational age who were under mechanical ventilation on nasal continuous positive air way pressure (NCPAP)afterINSURE (i.e. Intubation Surfactant early Extubation)their oxygenation and the vital signs . At first, randomly, they were positioned in supine or prone position for3 houres and then in another position for another 3houres while theiroxygenation , pulse and respiratory rate levels were measured every15minuet and episodes of desaturation, bradycardia ,apnea were measuring for3 houres in one position than 3 houres in another position. Oxygenation index , respiratory and pulse rate and episodes of desaturation, bradycardia and apnea were measuring by continuous monitoring. During the intervention, they received no or minimum procedure. They were excluded if they had the vital sign instability, or continuous episodes of SPO2 les than 80% or apnea, during the study period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109177569N1
Registration date:2011-10-28, 1390/08/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-28, 1390/08/06
Registrant information
Name
tahereh vafaienejad
Name of organization / entity
Yazd University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1751
Email address
vafa.nasim@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy for Yazd University of Medical Sciences
Expected recruitment start date
2009-03-08, 1387/12/18
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of prone and supine position’s effect, on the oxygenation and the vital signs in the preterm neonates who are under the nasal continuous positive air way pressure
Public title
The comparison of prone and supine position in preterm neonates under nasal continuous positive air way pressure .
in Amiralmomenin hospital in Semnan city
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: infants how, having no contraindicate for prone position Gestational age 28to 37 weeks, under the nasal continuous positive air way pressure after INSURE from previous 6 hours, having no congenital heart disease, having no intra ventricular hemorrhage, having no congenital diaphragmatic hernia, having no pulmonary interstitial emphysema , having no pneumothorax, having no sepsis with positive culture,Exclusion criteria: vital sign instability or continuous episodes of SPO2 les than 80% or apnea, during the study period.
Age
From 28 years old to 37 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 in Researches of Medical Sciences 0f Vice Chanceller for Research of yazd University of Medic
Street address
Vice Chanceller for Research, shahid bahonarsquare, University of Medical Sciences,Yazd.
City
Yazd
Postal code
8916978477
Approval date
2010-10-27, 1389/08/05
Ethics committee reference number
پ/17/1/81617
Health conditions studied
1
Description of health condition studied
premature newborns under mechanical ventilation
ICD-10 code
P07.3
ICD-10 code description
Disorders related to length of gestation and fetal growth
Primary outcomes
1
Description
Oxygenation,puls rate Respiratory rate
Timepoint
Every15minute for3hr every position
Method of measurement
Monitoring
Secondary outcomes
1
Description
Prevalence of bradycardia,Apnea,decrease of O2SAT,scale FIO2