The purpose of this study was to evaluate the effect of white plastic cover around the phototherapy equipment on its efficiency and safety in term neonates with icterus. This was done in a single blind and random fashion. The main inclusion criteria included gestational age less than 37, bilirubin level between 18 and 21.9 and those of the exclusion were hemolysis, age less than two and more than 14 and high level of direct bilirubin. The sample size included 182 uncomplicated neonates whom were randomly assigned into two different groups. The control and intervention groups were put under phototherapy without and with plastic cover, respectively. The neonates were checked for the appearance of probable complications such as hyperthermia, dehydration and so on, while receiving phototherapy. The main outcome of this study was to see the effect of the cover, put around the equipment, on the level of bilirubin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010184961N1
Registration date:2010-10-31, 1389/08/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-31, 1389/08/09
Registrant information
Name
Homa Babaei
Name of organization / entity
Kermanshah University of Medical Secinces
Country
Iran (Islamic Republic of)
Phone
00988314276303 داخلی 2292
Email address
homa_babaei@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2009-11-03, 1388/08/12
Expected recruitment end date
2010-10-27, 1389/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy and safety of white plastic cover around phototherapy unit in term jaundiced neonate: A randomized controlled trial
Public title
The efficacy and safety of white plastic cover around phototherapy unit in term jaundiced neonate: A randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: neonates who had gestational age of 37 and were more than 2500g with the Bilirubin level between 18 and 21, at the beginning of the phototherapy
Exclusion criteria: congenital malformations, hemolysis, increased direct Bilirubin ( >20% of the total Bilirubin), sepsis, age less than 48 hours and more than 2 weeks, at the beginning of phototherapy
Age
From 2 years old to 14 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
182
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Bulding no=2, Sepah Avenue, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6714415333
Approval date
2009-11-03, 1388/08/12
Ethics committee reference number
33386
Health conditions studied
1
Description of health condition studied
Hyperbilirubin in neonate
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Serum Bilirubin level
Timepoint
Each 12 hours
Method of measurement
Laboratory Bilirubin Assay Kit
Secondary outcomes
1
Description
Body Temperature
Timepoint
each 6 hours
Method of measurement
Thermometer
2
Description
Dehydatation
Timepoint
each 6 hours
Method of measurement
physical examination
3
Description
stool consistence
Timepoint
each 6 hours
Method of measurement
inspection
Intervention groups
1
Description
The intervention groups were put under single phototherapy with plastic cover
Category
Treatment - Devices
2
Description
The control group were put under single phototherapy without plastic cover.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Kermanshah University of Medical Sciences,
Full name of responsible person
Homa Babaei
Street address
Department of pediatrics, Imam Reza Hospital, Kermanshah University of Medical Sciences
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Najafi
Street address
Deputy of Research, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Homa Babaei, MD
Position
Neonatologist
Other areas of specialty/work
Street address
Department of Pediatrics, Imam Reza Hospital, Kermanshah
City
Kermanshah
Postal code
6714415333
Phone
+98 83 1427 6303
Fax
+98 83 1428 2670
Email
homa_babaei @kums.ac.irhoma_babaei @yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Homa Babaei, MD
Position
Neonatologist
Other areas of specialty/work
Street address
Department of Pediatrics, Imam Reza Hospital, Kermanshah
City
Kermanshah
Postal code
6714415333
Phone
+98 83 1427 6303
Fax
Email
homa_babaei@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Homa Babaei
Position
Neonatologist
Other areas of specialty/work
Street address
Department of pediatrics, Imam Reza Hospital, Kermanshah
City
Kermanshah
Postal code
6714415333
Phone
+98 83 1427 6303
Fax
Email
homa_babaei@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)