Protocol summary

Summary
The effects of prone positions on o2 saturation and heart rate in ventilated premature; thirty five cases of low birth weight infants (birth weight less than 2000 g ) and premature ( less than 34 weeks gestational age ) located under mechanical ventilation. Inclusion criteria: infants under mechanical ventilation for 2 hours supine position and physiological parameters recorded during this period every 10 minutes and the infant placed prone position for 2 hours during this time physiological parameters in 10 minutes by monitoring cardiac -inspiratory (monitoring SAADAT) measured by pulse oximeter and recorded and compared with the mean in each state. Infants studied, has the following entry criteria: mechanical ventilated premature newborns; less than 34 weeks of pregnancy; weighing less than 2000 grams; no congenital anomalies; without receipt sedation drugs; without umbilical artery catheters and umbilical vein catheters and chest tubes; at least 4 hours have mechanical ventilation; during the first 4 hours of mechanical ventilation without complications such as pneumothorax . Since to evaluate the arterial blood gas in low birth weight and prematurity is an invasive and painful, and the need for frequent blood sampling, repeated blood sampling decreased blood oxygen saturation is followed by the anemic baby, with comments supervisor, non-invasive monitoring of vital signs was used to evaluate study. The main outcome variable: the condition of the baby in the placement of two supine and prone position, female sex and male sex, gestational age is less than 34weeks gestational age, arterial blood oxygen saturation, birth weight, heart rate.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015032621542N1
Registration date: 2015-08-23, 1394/06/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-08-23, 1394/06/01
Registrant information
Name
Tahereh Babuyeh
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9596
Email address
t.babuyeh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2014-07-20, 1393/04/29
Expected recruitment end date
2015-04-13, 1394/01/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of prone positions on o2 saturation and heart rate in ventilated premature infants
Public title
The effects of prone positions on o2 saturation and heart rate in ventilated premature infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: infants mechanical ventilated premature newborns; less than 34 weeks of pregnancy; weighing less than 2000 grams. Exclusion criteria: non mechanical ventilated infants and mechanical ventilated infants over 34 weeks of pregnancy and weight more than 2000 grams; infants with congenital anomalies; under mechanical ventilation for less than 4 hours; recent receive sedation drugs; infants with umbilical vein catheters and umbilical artery catheters and chest tubes; infants during the first 4 hours of mechanical ventilation are complications such as pneumothorax.
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz st.
City
Babol
Postal code
4775447-976
Approval date
2014-08-02, 1393/05/11
Ethics committee reference number
9328533

Health conditions studied

1

Description of health condition studied
Respiratory and cardiovascular disorders specific to the perinatal period
ICD-10 code
P20-29
ICD-10 code description
Respiratory and cardiovascular disorders specific to the perinatal period

Primary outcomes

1

Description
O2 saturation
Timepoint
Every ten minutes during two hours while studying and sleeping in the supine position the abdomen position
Method of measurement
Pulsoxymeter

2

Description
Heart rate
Timepoint
Every ten minutes during two hours while studying and sleeping in the supine position the abdomen position
Method of measurement
Pulsoxymeter

Secondary outcomes

1

Description
Bradycardia
Timepoint
Every ten minutes during two hours while studying and
Method of measurement
Pulsoxymeter

2

Description
Tachycardia
Timepoint
Every ten minutes during two hours while studying and
Method of measurement
Pulsoxymeter

3

Description
Reduced blood arterial oxygen saturation
Timepoint
Every ten minutes during two hours while studying and Reduced blood arterial oxygen saturation Reduced blood arterial oxygen saturation Reduced blood arterial oxygen saturation reduced blood arterial oxygen saturation
Method of measurement
Pulsoxymeter

Intervention groups

1

Description
Thirty five cases of low birth weight infants ( birth weight less than 2000 g ) and premature ( less than 34 weeks gestational age ) located under mechanical ventilation , Inclusion Entry criteria infants under mechanical ventilation for 2 hours supine position and physiological parameters recorded during this period every 10 minutes and the infant placed prone position for 2 hours During this time physiological parameters in 10 minutes by monitoring cardiac -inspiratory ( monitoring SAADAT ) measured by pulse oximeter and recorded and compared with the mean in each state
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Rohani Hospital
Full name of responsible person
Tahereh Babuyeh
Street address
Ayatollah Rohani Hospital in Babol
City
Babol

2

Recruitment center
Name of recruitment center
Imam Ayatollah Khomeini
Full name of responsible person
Tahereh Babuyeh
Street address
Imam Ayatollah Khomeini in Sari
City
Sari

3

Recruitment center
Name of recruitment center
Boali Sina hospital
Full name of responsible person
Tahereh Babuyeh
Street address
Boali Sina hospital in Sari
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Moqhaddamnia
Street address
Babol University of Medical Sciences, Ganjafrooz st.
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Tahereh Babuyeh
Position
MSc student of neonatal intensive care nursing
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafrooz st.
City
Babol
Postal code
4775447-976
Phone
+98 119832238301
Fax
+98 11 3219 0624
Email
t.babuyeh@yahoo.com; t.babuyeh@mu.babol.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Tahereh Babuyeh
Position
MSc student of neonatal intensive care nursing
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafrooz st.
City
Babol
Postal code
4775447-976
Phone
+98 11 3223 8301
Fax
+98 11 3219 0624
Email
t.babuyeh@yahoo.com; t.babuyeh@mu.babol.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences, Ganjafrooz st.
Full name of responsible person
Tahereh Babuyeh
Position
MSc student of neonatal intensive care nursing
Other areas of specialty/work
Street address
Babol University of Medical Sciences, Ganjafrooz st.
City
Babol
Postal code
4775447-976
Phone
+98 11 3223 8301
Fax
+98 11 3219 0624
Email
t.babuyeh@yahoo.com; t.babuyeh@mu.babol.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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