An analysis of the effects of the position of premature infants suffering respiratory distress syndrome on arterial oxygen saturation, vital signs and abdominal distention attached to positive airway pressure device
This study aims to assess the impact of the position premature infants with respiratory distress syndrome on arterial oxygen saturation, vital signs and abdominal distention. The population of this study includes 26-week-old to 36-week-old infants, the first and fifth-minute Apgar scoring above seven and those attached to positive airway pressure device. The primary diagnosis of neonates was respiratory distress syndrome and they were dependent of oxygen. Infants requiring intubation were excluded. Samplings were accessibly carried out on 41 infants. Each infant was his/her own control. The position of the first infant, including supine or prone was determined randomly. Subsequently, the change of the positions continued in an alternate fashion to the last infant. The duration of each positioning was 2 hours. The percentage of arterial oxygen saturation, heart rate, respiratory rate and blood pressure in each position was measured every 30 minutes and recorded in questionnaires. The abdominal circumference was measured and recorded before and after each positioning. Body temperature was measured and recorded at the beginning of each position. Following every positioning, there was a 30-minute interval for the infant to reach stability in the new position, titled the washout period, after which parameters were measured and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101211089N1
Registration date:2015-06-13, 1394/03/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-13, 1394/03/23
Registrant information
Name
Farzaneh Balali
Name of organization / entity
Nursing And Midwifery School Of Shahid Beheshti
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
f.balali@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Nursing And Midwifery School of Shahid Beheshti
Expected recruitment start date
2011-11-26, 1390/09/05
Expected recruitment end date
2012-07-20, 1391/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An analysis of the effects of the position of premature infants suffering respiratory distress syndrome on arterial oxygen saturation, vital signs and abdominal distention attached to positive airway pressure device
Public title
The effect of positions on premature infants with respiratory distress syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 26-36 week-olds (gestational age); early diagnosis of respiratory distress syndrome; without history of congenital diseases; the first and the fifth minute Apgar scoring above seven; attachment to positive airway pressure device (nasal CPAP)
Exclusion criteria: Infection; requiring surgery or intubation
Age
From 1 day old to 2 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
41
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
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Yaman Street, Shahid Chamran
City
Tehran
Postal code
1985717443
Approval date
2013-06-02, 1392/03/12
Ethics committee reference number
sbmu.rec.1392.141
Health conditions studied
1
Description of health condition studied
Respiratory distress syndrome of newborn
ICD-10 code
P22.0
ICD-10 code description
Respiratory distress syndrome of newborn
Primary outcomes
1
Description
Heart rate
Timepoint
Every half hour for 2 hours
Method of measurement
Masimo Set pulse oximeter manufactured by Saadat company
2
Description
Saturation of arterial blood
Timepoint
Every half hour for 2 hours
Method of measurement
Masimo Set pulse oximeter manufactured by Saadat company