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Trial registered on ANZCTR
Registration number
ACTRN12624000860561p
Ethics application status
Submitted, not yet approved
Date submitted
7/06/2024
Date registered
12/07/2024
Date last updated
12/07/2024
Date data sharing statement initially provided
12/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Intermittent Phototherapy vs Continuous Phototherapy in Treating Neonatal Jaundice - A Randomized Controlled Trial
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Scientific title
Changes in Bilirubin with Intermittent Phototherapy vs Continuous Phototherapy for Treating Neonatal Jaundice - A Randomized Controlled Trial
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Secondary ID [1]
312186
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nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neonatal Jaundice
333852
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Condition category
Condition code
Reproductive Health and Childbirth
330525
330525
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0
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Complications of newborn
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Reproductive Health and Childbirth
330859
330859
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0
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Childbirth and postnatal care
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Physical Medicine / Rehabilitation
330860
330860
0
0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intermittent Phototherapy. Babies who fulfil inclusion criteria will be selected into the study. Baseline serum bilirubin will be taken. They will undergo phototherapy for 10 hours and phototherapy will stop. After 6 hours without phototherapy, venous blood gas will be taken to see the bilirubin level as to prevent rebound jaundice. If the level requires phototherapy, we will restart the phototherapy and withdraw them from study to proceed with standard treatment. If they do not require phototherapy, another serum bilirubin will be taken at 24 hours of study. If they require another phototherapy, it is considered treatment failure. We will restart the phototherapy and proceed with standard treatment.
The level that used to decide babies requiring phototherapy will be based on their age and risk following Malaysia Paediatric Protocol page 139.
The phototherapy machine used is the same for both groups which is Niscomed Bistos LED Phototherapy System. It consists of 8 LED lights at the top chamber each delivering 25 - 35 µW/cm²/nm.
To ensure adherence to the intervention, we will place baby in a cot and place them under phototherapy. The nursing time is same for all babies, this is to minimize interruption of treatment.
Medical Officer and nurses will participate in this intervention including starting phototherapy, blood taking and nursing care of the patient,
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Intervention code [1]
328893
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Treatment: Other
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Comparator / control treatment
Continuous Phototherapy. Babies that fulfil inclusion criteria will be selected into the study, Baseline serum bilirubin will be taken and they will undergo phototherapy for 24 hours. After 24 hours, another serum bilirubin will be taken. If they need to continue the phototherapy, then they are considered as treatment failure.
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Control group
Active
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Outcomes
Primary outcome [1]
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Rate of decline of bilirubin per hour in each group
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Assessment method [1]
338294
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serum bilirubin level
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Timepoint [1]
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Baseline bilirubin level before starting phototherapy and at 24 hours post baseline bilirubin level
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Secondary outcome [1]
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compare the mean of serum bilirubin post 24 hours phototherapy
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Assessment method [1]
435317
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Serum bilirubin
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Timepoint [1]
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24 hours serum bilirubin post baseline
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Secondary outcome [2]
435318
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compare the rate of treatment failure in each group
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Assessment method [2]
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serum bilirubin
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Timepoint [2]
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serum bilirubin at 24 hours post baseline will be used to decide to continue or stop the phototherapy. Require another phototherapy will be consider as treatment failure
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Eligibility
Key inclusion criteria
1. Bilirubin level must be within 50umol/L from phototherapy level based on age
2. Age must be more than 24 hours but less than 2 weeks of life
3. Gestational age more than 38 weeks
4. Birth weight more than 2.5kg
5. Low risk based on Malaysia Paediatric Protocol in which subjects do not have the following risk factors : ABO incompatibility, Glucose-6-phosphate dehydrogenase (G6PD) deficiency, clinical sepsis, Rhesus isoimmunization, asphyxia
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Minimum age
24
Hours
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Maximum age
14
Days
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. severe jaundice required intensive phototherapy
2. syndromic babies
3. had risk factos such as ABO incompatibility, G6PD deficiency, clinical sepsis, Rhesus isoimmunization, asphyxia
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization by Microsoft Excel
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
74
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26314
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Malaysia
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State/province [1]
26314
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Funding & Sponsors
Funding source category [1]
316559
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Hospital
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Name [1]
316559
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Hospital Universiti Sains Malaysia
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Address [1]
316559
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Country [1]
316559
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Malaysia
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Primary sponsor type
University
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Name
Universiti Sains Malaysia
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Address
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Country
Malaysia
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Secondary sponsor category [1]
318686
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None
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Name [1]
318686
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Address [1]
318686
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Country [1]
318686
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
315303
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Jawatankuasa Etika Penyelidikan Manusia
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Ethics committee address [1]
315303
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HOSPITAL UNIVERSITI SAINS MALAYSIA ,KUBANG KERIAN ,16150 KUBANG KERIAN ,KELANTAN
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Ethics committee country [1]
315303
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Malaysia
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Date submitted for ethics approval [1]
315303
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04/02/2024
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Approval date [1]
315303
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Ethics approval number [1]
315303
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USM/JEPem/KK/24020150
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Summary
Brief summary
This is a randomized controlled trial to compare the effectiveness of intermittent phototherapy vs continous phototherapy in treating neonatal jaundice. Our hypothesis is intermittent phototherapy is as effective as continuous phototherapy. If our hypothesis is proven in this study, thus we can apply intermittent phototherapy in our practice. By using the data, we can practice daycare phototherapy to minimize ward congestion and improve resources management.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
134274
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Dr Ong Jia Cheng
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Address
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Department of Paediatrics, Hospital Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, 16150 Kota Bahru, Kelantan
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Country
134274
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Malaysia
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Phone
134274
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+60142924219
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Fax
134274
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Email
134274
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[email protected]
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Contact person for public queries
Name
134275
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Ong Jia Cheng
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Address
134275
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Department of Paediatrics, Hospital Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, 16150 Kota Bahru, Kelantan
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Country
134275
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Malaysia
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Phone
134275
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+60142924219
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Fax
134275
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Email
134275
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[email protected]
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Contact person for scientific queries
Name
134276
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Ong Jia Cheng
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Address
134276
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Department of Paediatrics, Hospital Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, 16150 Kota Bahru, Kelantan
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Country
134276
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Malaysia
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Phone
134276
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+60142924219
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Fax
134276
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Email
134276
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
22441
Study protocol
387804-(Uploaded-07-06-2024-11-43-05)-study protocol.docx
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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