The aim of the study: the effect of ambient lighting on heart rate and blood oxygen saturation in preterm infants in the NICU.
Performing study design: non-random
Studied mass population: 40 premature infants hospitalized in subordinate hospitals of Babol city.
Inclusion criteria: premature infants less than 37 weeks; weighing less than 2500 grams; without the need for mechanical ventilation and oxygen therapy; arterial oxygen saturation in normal range.
Exclusion criteria: existence of neurological- vision problems; congenital anomalies; sepsis; gastro - intestinal tract problems; congenital heart disease; respiratory distress syndrome with more or equal to 5; maternal drug addiction; drugs affecting on heart rate and arterial oxygen saturation percentage; infants undergoing phototherapy in the hospital and suffering invasive procedures.
Brightness severity through the luxury meter units, recording heart rate and blood oxygen saturation in preterm infants by Saadat monitor was measured, infants at a certain time from 12:00 to 13:00 (routine based) the amount of brightness was recorded by luxury meters every 5 minutes and then the heart rate and blood oxygen saturation in the monitor display will be registered. On the same day, for the same child, between the hours of 14: 30-15:30 brightness reached 10 luxuries and we record its effect on heart rate and oxygen saturation every 5 minutes during the intervention.
The primary outcome: the ambient lighting, heart rate, blood oxygen saturation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014051217669N1
Registration date:2014-06-23, 1393/04/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-23, 1393/04/02
Registrant information
Name
Saide Manochehri
Name of organization / entity
Babol University of Medical Science.
Country
Iran (Islamic Republic of)
Phone
+98 17 3372 4668
Email address
manochehri.saide@yahoo.com
Recruitment status
Recruitment complete
Funding source
personal.
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-04-19, 1393/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ambient lighting on heart rate and blood oxygen saturation in preterm infant admitted to neonatal intensive care unit in Babol, Iran
Public title
The effect of ambient lighting in preterm infant
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: premature infants less than 37 weeks; weighing less than 2500 grams; without the need for mechanical ventilation and oxygen therapy; arterial oxygen saturation in normal range.
Exclusion criteria: existence of neurological- vision problems; congenital anomalies; sepsis; gastro - intestinal tract problems; congenital heart disease; respiratory distress syndrome with more or equal to 5; maternal drug addiction; drugs affecting on heart rate and arterial oxygen saturation percentage; infants undergoing phototherapy in the hospital and suffering invasive procedures.
Age
From 5 days old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
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 Babol University of Medical Sciences
Street address
Research and Technology، Ganjafroz Street Babol university of Medical Science، Babol، Mazandaran، Iran.
City
Babol
Postal code
Approval date
2013-12-03, 1392/09/12
Ethics committee reference number
3461 /30/ژ/پ
Health conditions studied
1
Description of health condition studied
Effect of ambient lighting on heart rate and blood oxygen saturation in preterm infant
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants
Primary outcomes
1
Description
Ambient lighting
Timepoint
Before and during intervention every 5 minutes to an hour
Method of measurement
In terms of luxury and using luxury meter device
2
Description
Hear rate
Timepoint
Before and during intervention every 5 minutes to an hour
Method of measurement
In terms of beats per minute using Monitor
3
Description
Blood oxygen saturation
Timepoint
Before and during intervention every 5 minutes to an hour
Method of measurement
In terms of percentage using Monitor
Secondary outcomes
1
Description
Gestational age
Timepoint
After birth
Method of measurement
In terms of day and week using Ballard scale.
2
Description
Weight
Timepoint
After birth
Method of measurement
In terms of gram using Balance
Intervention groups
1
Description
In this study, gestational age was calculated by Ballard scale and intensity of brightness in the NICU through a device called a luxury meter with 3% ± confidence level in Taiwan, heart rate and oxygen saturation percentage in preterm infants by Saadat monitor, made in Iran was measured. In order to record data on the monitor, we use the probe including a light detector, put against each other and also the tissue layers (fingers of hand or foot) and also between them. In order to get demographic information, we use birth records after attracting personnel and explaining to the parents and getting consent from them. According to selected Infants at the same time from 12:00 to 13:00 on a routine part, amount of brightness have been estimated and recorded by luxury meter and then we record heart rate and arterial oxygen saturation percentage displayed on the monitor every 5 minutes. On the same day, on the same infant from 14:30 to 15:30, amount of brightness through controlling light by covering the incubator and putting the cover on the window with the blinds and turning off non-essential lights reached 10 luxuries and then we record their effect on heart rate and arterial oxygen saturation percentage every 5 minutes during the intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kola Children's Hospital
Full name of responsible person
Mr.Doctor Mousa Ahmadpour.
Street address
Research Institute of children Non Communicable Diseases، Amir Kola Children's Hospital Babol، Mazandran، Iran.