The main purpose of the study:
-Determining the Effect and Complications of High-Power Single and Double-Level Phototherapy in Nonconjugated Jaundice in Neonates Hospitalized in Be'sat Hospital, Hamadan
Aims:
-Determination and Comparison of the Effectiveness of Single and Double surface Intensive Phototherapy on Indirect Bilirubin Levels
-Determination and Comparison of the Effect of Single and Double surface Intensive Phototherapy on Serum Calcium Level
-Determination and comparison of the effect of Single and Double surface Intensive Phototherapy on platelet count
-Determination and comparison of the effect of Single and Double surface Intensive Phototherapy on the length of hospital stay
-Determination and comparison of the effect of Single and Double surface Intensive Phototherapy on the fecal excretion status
- Determining and comparing the effect of Single and Double surface Intensive Phototherapy on Patient's body temperature
-Determination and comparison of the effect of high-level and two-level high-power phototherapy on incidence of skin rash
Design
Prospective study, Randomized clinical trial
Settings and conduct
Neonates Ward of Be'sat Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Term healthy newborn; Age less than 14 days; Birth weight ≥ 2500 grams; nonmolytic hyperbilirubinemia; Serum total bilirubin concentration between 15-20 mg/dl
Exclusive Breastfeeding
Exclusion criteria:
Asphyxia; Pre-term; Bilirubin encephalopathy; Sepsis
Intervention groups
In 1st group, treated only with single surface intensive phototherapy, 6 lamps of chamber irradiate at distance of 20-30 cm, angle of 0-180°
In 2nd group, treated only with double surface intensive phototherapy, 12 lamps of chamber irradiate at distance of 20-30 cm, angle of 0-360°
Main outcome variables
Indirect bilirubin; Serum calcium level; Platelet count, Duration of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191203045595N1
Registration date:2019-12-16, 1398/09/25
Registration timing:prospective
Last update:2019-12-16, 1398/09/25
Update count:0
Registration date
2019-12-16, 1398/09/25
Registrant information
Name
Shadi VEISI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3827 0172
Email address
shadiwaisi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-06-21, 1399/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effectiveness and Side Effects of Single and Double surface Intensive Phototherapy on Neonatal Jaundice in Be’sat Hospital, Hamedan
Public title
Evaluation of Effectiveness and Side Effects of Single and Double surface Intensive Phototherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy term infant, with non-hemolytic hyperbilirubinemia with total serum bilirubin between 15-20 mg/dl
1-14 days old
Exclusion criteria:
Asphyxia
Pre-term
Age
From 1 day old to 14 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with any level of bilirubin were randomly divided into two groups of 75 each. The questionnaires were coded from 1 to 150 (from 1 to 75 for single-level phototherapy and from 76 to 150 for two-level phototherapy). After each infant is enrolled in the study, one of the numbers is identified by lot and the questionnaire is filled out during the intervention.
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 Hamedan University of Medical Sciences
Before intervention and then every 24 hours until discharge
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Single Surface Intensive Phototherapy. Patients are placed inside a Tosan double surface intensive phototherapy machine that provides 180 degrees illumination from up, at a distance of 20-30 cm. treatment continues uninterrupted until reducing Bilirubin to less than 10mg/dl.
Category
Treatment - Other
2
Description
Intervention group 2: ِDouble Surface Intensive Phototherapy. Patients are placed inside a Tosan double surface intensive phototherapy machine that provides 360 degrees illumination from a distance of 20-30 cm. treatment continues uninterrupted until reducing Bilirubin to less than 10mg/dl.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Be'sat Hospital
Full name of responsible person
Shadi Veisi
Street address
Shahid Beheshti Blvd.
City
Hamedan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3827 0172
Email
shadiwaisi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Vice Chancellor for Research and Technology, Hamedan University of Medical Sciences, Shahid Fahmideh Blvd, Mahdieh St.
City
Hamedan
Province
Hamadan
Postal code
6517838696
Phone
+98 81 3838 0717
Email
bashirian@umsha.ac.ir
Web page address
http://research.umsha.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?