Protocol summary
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Study aim
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Comparison of Periodic Phototherapy with Continuous Phototherapy in the Treatment of VLBW Neonatal Jaundice in NICU ward
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Design
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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.
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Settings and conduct
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Infants hospitalized in neonatal intensive care unit of Afzalipour Hospital in Kerman with age 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
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Weight 1000 to 1500 g (GA: 28-32 wks)
Not receiving previous phototherapy
Need to receive phototherapy
Age less than 24 hours
Exclusion criteria:
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
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Intervention groups
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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.
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Main outcome variables
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Reducing phototherapy complications by reducing phototherapy time
General information
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Reason for update
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We forgot to enter the age range. To prevent IUGR babies from entering, we decided to specify the age range.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20211218053444N1
Registration date:
2022-02-22, 1400/12/03
Registration timing:
prospective
Last update:
2026-06-22, 1405/04/01
Update count:
1
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Registration date
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2022-02-22, 1400/12/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-03-05, 1400/12/14
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Expected recruitment end date
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2022-06-09, 1401/03/19
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of cycled phototherapy with continuous phototherapy in treatment of jaundice in premature very low-birth-weight (VLBW) neonates
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Public title
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Cycled phototherapy in treatment of neontal jaundice
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Weight 1000 to 1500 grams (GA: 28-32 wks)
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
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Age
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From 1 day old to 1 day old
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Gender
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Both
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Phase
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1-2
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
150
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-11-04, 1400/08/13
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Ethics committee reference number
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IR.KMU.AH.REC.1400.185
Health conditions studied
1
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Description of health condition studied
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Neonatal Jaundice
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ICD-10 code
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P59.8
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ICD-10 code description
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Neonatal jaundice from other specified causes
Primary outcomes
1
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Description
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Neonatal jaundice rate
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Timepoint
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The primary outcomes were the mean peak TSB levels and total hours of phototherapy during the first 14 days of life.
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Method of measurement
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Serum bilirubin levels
Intervention groups
1
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Description
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Intervention group: The effect of intermittent phototherapy on very low birth weight infants.
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Category
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Treatment - Devices
2
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Description
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Control group: The effect of continuous phototherapy in very low birth weight infants. Infants will be classified into high-risk and low-risk groups based on their intubation status and then randomly assigned to one of the two groups in a 1:1 ratio. The first group will receive continuous phototherapy and the other group will receive intermittent phototherapy for 15 minutes per hour. The infants' total serum bilirubin levels will be measured daily for seven days after birth and also on the day phototherapy is administered or stopped in the second week after birth. If more than one total serum bilirubin sample was taken per day, the total serum bilirubin level that was closest to 7 a.m. and the highest total serum bilirubin level of the day will both be recorded. The average total hours of phototherapy in the two groups will also be recorded and used for statistical comparison. Light-emitting diode phototherapy lamps will be used to emit narrow-spectrum blue light. The intensity of the phototherapy lamp will be preset so that patients receive 22 microwatts/cm2/nm of light at the low setting and 33 microwatts/cm2/nm at the high setting. The V-wave latency of the auditory brainstem evoked responses, a sensitive marker of bilirubin neurotoxicity, is also measured.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kerman University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Information will be shared, but how it will be published will be announced later
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When the data will become available and for how long
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Information will be shared, but how it will be published will be announced later
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To whom data/document is available
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Information will be shared, but how it will be published will be announced later
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Under which criteria data/document could be used
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Information will be shared, but how it will be published will be announced later
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From where data/document is obtainable
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Information will be shared, but how it will be published will be announced later
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What processes are involved for a request to access data/document
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Information will be shared, but how it will be published will be announced later
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Comments
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