Comparison of Periodic Phototherapy with Continuous Phototherapy in the Treatment of VLBW Neonatal Jaundice in NICU ward
Design
Clinical trial with two groups with continuous phototherapy (control) and
With parallel, two-way blind groups, randomized phase 1_2 on 150 patients, the rand function of Excel software was used for randomization.
Settings and conduct
Infants hospitalized in neonatal intensive care unit of Afzalipour Hospital in Kerman with jaundice less than one day have been selected and due to intubation or not, they are placed in two groups and then blinding is done for receiving permanent or periodic phototherapy among parents of infants, researcher, vanalisor assessor group according to the need for intervention in order to discontinue phototherapy in periodic type or receive phototherapy. Permanently do not go blind in case of excessive bilirubin increase
Participants/Inclusion and exclusion criteria
Entry requirements:
Weight 1000 to 1500 g
Not receiving previous phototherapy
Need to receive phototherapy
Age less than 24 hours
Non-entry requirements:
Known hemolytic disease
Asphykisia
Nonbacterial infection overt
The existence of major anomalies
Unstable conditions (pH of arterial blood less than 6.8 for more than 2 hours, stable bradycardia associated with hypoxia over 2 hours)
Informed dissatisfaction of parents or legal guardian of the infant to enter the study
Intervention groups
The effect of phototherapy at 15 minutes per hour in infants weighing 1000-1500 grams hospitalized in NICU ward with control group receiving continuous phototherapy and comparing the efficacy and effects in both groups.
Main outcome variables
Treatment of Neonatal Jaundice
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211218053444N1
Registration date:2022-02-22, 1400/12/03
Registration timing:prospective
Last update:2022-02-22, 1400/12/03
Update count:0
Registration date
2022-02-22, 1400/12/03
Registrant information
Name
Zahra Jamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 8198
Email address
z.jamali@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-05, 1400/12/14
Expected recruitment end date
2022-06-09, 1401/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cycled phototherapy with continuous phototherapy in treatment of jaundice in premature VLBW neonates
Public title
Cycled phototherapy in treatment of neontal jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Weight 1000 to 1500 grams
Failure to receive previous phototherapy
Need to receive phototherapy
Age less than 24 hours
Exclusion criteria:
Known hemolytic disease
Asphyxia
Non-bacterial infection overt
Existence of major anomalies
Unstable conditions (arterial blood pH less than 6.8 for more than 2 hours, stable bradycardia associated with hypoxia for more than 2 hours)
Unwanted consent of the baby's parents or legal guardian to enter the study
Age
From 1 day old to 1 day old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
The Infants will be Admitted to the Study by Observing the Inclusion Criteria, Which will be Classified into two Groups, High Risk and Low Risk, based on the State of Intubation, and then Will Be Randomly Divided into two Groups with a Ratio of 1: 1. the First Group will Receive Continuous Phototherapy and the Other Group Will Receive Periodic Phototherapy Beds for 15 Minutes Per Hour.
Blinding (investigator's opinion)
Double blinded
Blinding description
Parents of infants participating in the study will be blinded in one of two groups after obtaining consent .Clinical caregivers are not blinded due to direct involvement with the baby and the need to discontinue phototherapy at the desired time. The researcher ,the assessor and the enlisor are blind in this study and extract the results from patient records
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Ebn-e-Sina St., Jahad Blvd., Kerman
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2021-11-03, 1400/08/12
Ethics committee reference number
IR.KMU.AH.REC.1400.185
Health conditions studied
1
Description of health condition studied
Neonatal Jaundice
ICD-10 code
jaundice
ICD-10 code description
زردی نوزادان
Primary outcomes
1
Description
Neonatal jaundice rate
Timepoint
Fourteen days
Method of measurement
Serum bilirubin levels
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The effect of periodic phototherapy on VLBW neonates Control group: Effect of permanent phototherapy on VLBW neonates . Neonates will be classified into two groups of high risk and low risk based on intubation status and then randomly divided into two groups with a ratio of 1 to 1. The first group will undergo continuous phototherapy and the other group will be subjected to periodic phototherapy bed for 15 minutes per hour. Serum bilirubin total levels (TSB) of newborns will be measured daily for up to seven days after birth and also on the day that phototherapy was administered or stopped in the second week after birth. Also, the average total hours of phototherapy will be recorded in two groups and will be used for statistical comparison .Light-emitting diode phototherapy lamps will be used to irradiate the blue light of the narrow spectrum. The irradiance intensity of phototherapy lamp will be pre-adjusted so that patients receive 22 μW/cm2/nm of light in low settings equal to 33 μW/cm2/nm in high settings .V wave delay in Brainstem auditory-evoked responses (BAERs), a neurotoxicity sensitive marker with bilirubin, is also measured.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Zahra Jamali
Street address
Emam Blvd., Afazlipour Hospital .NICU
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
z.jamali@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zahra Jamali
Street address
Emam Blvd., Afazlipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
z.jamali@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zahra Jamali
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Emam Blvd., Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
031328000
Email
z.jamali@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zahran Jamali
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Emam Blvd., Afzalipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
z.jamali@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zahra Jamali
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Blvd., Afazlipour Hospital
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
009831328000
Email
z.jamali@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information will be shared, but how it will be published will be announced later
When the data will become available and for how long
Information will be shared, but how it will be published will be announced later
To whom data/document is available
Information will be shared, but how it will be published will be announced later
Under which criteria data/document could be used
Information will be shared, but how it will be published will be announced later
From where data/document is obtainable
Information will be shared, but how it will be published will be announced later
What processes are involved for a request to access data/document
Information will be shared, but how it will be published will be announced later