: Determination and comparison of two positions (prone-supine) on the vital parameters of premature infants with respiratory distress admitted to the neonatal intensive care unit of selected hospital of Baqiyatallah University of Medical Sciences, Tehran-
Design
The present study is a clinical trial t. Najmieh Hospital neonates are performed on 80 premature infants. Sampling in this study will be done in consultation with the respected professor of statistics according to Cochran's formula.
Settings and conduct
Sampling will be done randomly by first completing the initial infant evaluation : the case and control groups. The control group changes position every 3 hours, which is routine, and the case group changes position every 2 hours, .
This study is performed on 80 premature infants in the neonatal intensive care unit of Najmieh Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Infants who are premature (28-35 weeks)
2. Infants who are in the first 1-3 days of their birth.
3. Infants with respiratory distress.
4. Infants who are not treated with mechanical ventilation.
5- Infants who have 75-90% oxygen saturation.
6- Infants who have more than 60 breaths per minute.
7. Infants with a heart rate of more than 160 beats per minute.
8. Infants who do not have a congenital anomaly.
Exclusion criteria:
1- Death or discharge of the infant before the completion of the research period
2- Transferring the baby to another hospital
Intervention groups
The control group changes position every 3 hours, which is according to the routine section, and the case group changes position every 2 hours
Main outcome variables
The position of the lower back may affect the vital parameters of premature infants with respiratory distress
The supine position may affect the vital parameters of infants with respiratory distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190611043863N1
Registration date:2021-01-02, 1399/10/13
Registration timing:retrospective
Last update:2021-01-02, 1399/10/13
Update count:0
Registration date
2021-01-02, 1399/10/13
Registrant information
Name
Zahra Bashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6647 3810
Email address
zahrabashi8@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2020-02-20, 1398/12/01
Trial completion date
2020-02-20, 1398/12/01
Scientific title
comparison of two position(prone-supine) on vital parameters of premature infants with respiratory distress admitted in NIcU
Public title
comparison of two position(prone-supine) on vital parameters of premature infants with respiratory distress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Infants who are premature (28-35 weeks old) 2- Infants who are in the first 1-3 days of their birth 3. Infants who have respiratory distress 4. Infants who are not treated with mechanical ventilation Oxygen saturation is 90-75%. 6. Infants with respiratory rate greater than 60 in. Precise infants with heart rate exceeding 160 minutes
Exclusion criteria:
1-death or discharge of the infant before the completion of the research period 2-transfer of the infant to another hospital
Age
From 1 day old to 3 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
To select the samples in this study, simple random sampling has been used so that the researcher by attending the neonatal ward in the morning, evening and night shifts to sample the neonates with inclusion criteria and the names of the neonates in the sheets It is written in small and separate and placed in dark nylon and using the lottery method, the sheets are taken out and placed in the case and control groups, respectively, ie the first person in the case group and the second person in the control group until the end.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tahran Azad University of Medical Sciences