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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
Scientific title
Changes in Bilirubin with Intermittent Phototherapy vs Continuous Phototherapy for Treating Neonatal Jaundice - A Randomized Controlled Trial
Secondary ID [1] 312186 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal Jaundice 333852 0
Condition category
Condition code
Reproductive Health and Childbirth 330525 330525 0 0
Complications of newborn
Reproductive Health and Childbirth 330859 330859 0 0
Childbirth and postnatal care
Physical Medicine / Rehabilitation 330860 330860 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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,
Intervention code [1] 328893 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 338294 0
Rate of decline of bilirubin per hour in each group
Timepoint [1] 338294 0
Baseline bilirubin level before starting phototherapy and at 24 hours post baseline bilirubin level
Secondary outcome [1] 435317 0
compare the mean of serum bilirubin post 24 hours phototherapy
Timepoint [1] 435317 0
24 hours serum bilirubin post baseline
Secondary outcome [2] 435318 0
compare the rate of treatment failure in each group
Timepoint [2] 435318 0
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

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
Minimum age
24 Hours
Maximum age
14 Days
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization by Microsoft Excel
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment outside Australia
Country [1] 26314 0
Malaysia
State/province [1] 26314 0

Funding & Sponsors
Funding source category [1] 316559 0
Hospital
Name [1] 316559 0
Hospital Universiti Sains Malaysia
Country [1] 316559 0
Malaysia
Primary sponsor type
University
Name
Universiti Sains Malaysia
Address
Country
Malaysia
Secondary sponsor category [1] 318686 0
None
Name [1] 318686 0
Address [1] 318686 0
Country [1] 318686 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315303 0
Jawatankuasa Etika Penyelidikan Manusia
Ethics committee address [1] 315303 0
Ethics committee country [1] 315303 0
Malaysia
Date submitted for ethics approval [1] 315303 0
04/02/2024
Approval date [1] 315303 0
Ethics approval number [1] 315303 0
USM/JEPem/KK/24020150

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134274 0
Dr Ong Jia Cheng
Address 134274 0
Department of Paediatrics, Hospital Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, 16150 Kota Bahru, Kelantan
Country 134274 0
Malaysia
Phone 134274 0
+60142924219
Fax 134274 0
Email 134274 0
[email protected]
Contact person for public queries
Name 134275 0
Ong Jia Cheng
Address 134275 0
Department of Paediatrics, Hospital Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, 16150 Kota Bahru, Kelantan
Country 134275 0
Malaysia
Phone 134275 0
+60142924219
Fax 134275 0
Email 134275 0
[email protected]
Contact person for scientific queries
Name 134276 0
Ong Jia Cheng
Address 134276 0
Department of Paediatrics, Hospital Universiti Sains Malaysia, Jalan Raja Perempuan Zainab II, 16150 Kota Bahru, Kelantan
Country 134276 0
Malaysia
Phone 134276 0
+60142924219
Fax 134276 0
Email 134276 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22441Study 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.