Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000590561
Ethics application status
Approved
Date submitted
13/03/2024
Date registered
9/05/2024
Date last updated
9/05/2024
Date data sharing statement initially provided
9/05/2024
Date results information initially provided
9/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised Controlled Trial on 360° Phototherapy versus Single Surface LED Phototherapy in Neonatal Hyperbilirubinemia
Scientific title
Randomised Controlled Trial on 360° Phototherapy versus Single Surface LED Phototherapy in Neonatal Hyperbilirubinemia
Secondary ID [1] 311730 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal hyperbilirubinemia 333211 0
Condition category
Condition code
Reproductive Health and Childbirth 329899 329899 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised controlled trial.
Phototherapy units are set up for both intervention and control groups, which will involve 1 unit of a new 360’ phototherapy device for intervention group and few units of single surface LED phototherapy device for control group. The phototherapy units will be serviced before the study began and it will be maintained in optimal working condition for whole duration of the therapy.
The 360’ phototherapy consist of LED blue light (40 LED lights each at the top and bottom of the device). Both of the top and bottom of the device will be made sure to be close throughout the study.
The distance between phototherapy unit and babies will be fixed at 30cm for both of the control and intervention group. Pre-study evaluation of light intensity measurement from three different angles (front -- at level of neonate’s skin [on anterior thoracic region – which is the centre of phototherapy light], right and left of the babies) will be done for both 360’ and single surface LED phototherapy using ‘FANEM radiation monitor 2620’. This evaluation will only be done before the start of intervention for all participants involved. This is done to monitor the light intensity emitted by the devices used in the study in all participants involved, measured in uW/cm2/nm. The light intensity for both will be kept at level 5. The intervention will be administered by the NICU staff nurses or health officers in charged.
While receiving phototherapy, the light will be continuously on, except during feeding, physical examination and blood taking. Breastfeeding will be continued as per ‘Malaysian Neonatal Jaundice Guideline’. Interruption time will be monitored and restricted. All neonates involved will be ensured to have adequate exposure to the light, in which they will be dressed with nappies only during treatment in both groups, eyes will be covered to prevent retinal damage and strict adherence to study protocol will be ensured.
The phototherapy session will be continuous except during feeding, physical examination and blood taking to maintain the optimal therapy. After 24 hours, the intervention will be discontinued. Subjects who still required phototherapy after 24 hours will continue with the treatment irrespective of the type of phototherapy. Intervention will also be discontinued if subjects’ serum bilirubin level are below phototherapy level before reaching 24-hour.
All data will then be collected using the proforma checklist. The proforma form will be labelled with code numbers to ensure the confidentiality of all participants are preserved. The proforma form will consists of baseline data, safety profiles monitoring during phototherapy and blood sampling parameters.
Intervention code [1] 328191 0
Treatment: Devices
Comparator / control treatment
Single surface LED phototherapy devices are used as the control group.
Light source consist of 24 pieces of blue LED light (super bright LED). Light intensity will be measured at the start of each study at three different angles (front, right and left). The distance of phototherapy to anterior chest of the baby will be fixed at 30cm.
The intervention will be administered by any of the healthcare members involved ie NICU staff nurses or medical officers.
The phototherapy session will be continuous except during feeding, physical examination and blood taking to maintain the optimal therapy. After 24 hours, the intervention will be discontinued. Subjects who still required phototherapy after 24 hours will continue with the treatment irrespective of the type of phototherapy. Intervention will also be discontinued if subjects’ serum bilirubin level are below phototherapy level before reaching 24-hour.
Control group
Active

Outcomes
Primary outcome [1] 337667 0
Serum bilirubin level
Timepoint [1] 337667 0
The serum bilirubin will be repeated at 4-hour, 10-hour and 24-hour post commencement of phototherapy.
Secondary outcome [1] 432754 0
Safety of phototherapy
Timepoint [1] 432754 0
Safety of phototherapy by the monitoring of the temperature (at start of phototherapy, 4-hr, 10-hr, 24-hr), oxygen saturation monitoring (at start of phototherapy, 4-hr, 10-hr, 24-hr), hydration status by assessment of; weight (at initial, and at 24-hour), and based on clinical assessment. Presence of any skin rash (by end of intervention) will also be monitored. Monitoring of babies stool frequency over 24 hours since start of phototherapy will also be done.
Secondary outcome [2] 432756 0
Ease of usage of phototherapy
Timepoint [2] 432756 0
the questionnaire will be completed during cessation of the study

Eligibility
Key inclusion criteria
The study will include all term neonates who are born at 35 weeks of age or more, and age less than or equal to 7 days, with unconjugated hyperbilirubinemia, requiring intensive phototherapy following the Malaysian guideline of neonatal jaundice. The neonates weight must be 2 kg or more and has not received any phototherapy before.
Minimum age
No limit
Maximum age
7 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neonates whose serum bilirubin level is above the exchange transfusion level following the Malaysian guideline of neonatal jaundice will not be included in the study. Other exclusion criterias include direct hyperbilirubinemia of >15%, neonates with congenital abnormalities or inborn error of metabolism and neonates who required intensive care.

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)
The participants will be allocated into intervention or control group by using opaque, sealed and stapled envelopes which contained the group assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation is by random allocation sequence. For allocation of the participants, block randomisation, based on computer generated table, will be used for randomisation of all subjects into either of the two groups (360’ phototherapy = intervention group, single surface LED phototherapy = control group) with 1:1 ratio
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be used to summarise the socio-demographic characteristics of subjects. Numerical data will be presented as mean (SD) or median (IQR) based on their normality distribution. Categorical data will be presented as frequency (percentage).
To compare mean decrease in serum bilirubin after 4 hours, 10 hours, 24 hours of phototherapy using 360° phototherapy versus single surface LED phototherapy, mixed factorial ANOVA will be used. For the side effects of phototherapy using 360° phototherapy versus single surface LED phototherapy, it is either independant T-test/chi square test/ mixed factorial ANOVA will be used depending on the variables tested. If numerical variable is not normally distributed, non-parametric test, (Mann Whitney) will be used to compare between groups. Chi square test will be used to analyse the ease of usage of phototherapy device by the health care staff (staff nurses) in Neonatal Intensive Care Unit (NICU).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/12/2022
Date of last participant enrolment
Anticipated
Actual
13/03/2023
Date of last data collection
Anticipated
Actual
13/03/2023
Sample size
Target
38
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 26199 0
Malaysia
State/province [1] 26199 0
KELANTAN

Funding & Sponsors
Funding source category [1] 316061 0
Hospital
Name [1] 316061 0
Hospital Universiti Sains Malaysia
Country [1] 316061 0
Malaysia
Primary sponsor type
University
Name
Universiti Sains Malaysia
Address
Country
Malaysia
Secondary sponsor category [1] 318411 0
None
Name [1] 318411 0
Address [1] 318411 0
Country [1] 318411 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314880 0
Human Research Ethics Committee USM
Ethics committee address [1] 314880 0
USM Health Campus, 16150, Kubang Kerian, Kelantan. 097672354
Ethics committee country [1] 314880 0
Malaysia
Date submitted for ethics approval [1] 314880 0
17/07/2022
Approval date [1] 314880 0
17/11/2022
Ethics approval number [1] 314880 0

Summary
Brief summary
This is a randomised controlled trial on 360° phototherapy versus single surface LED phototherapy in neonatal hyperbilirubinemia requiring intensive phototherapy by comparing the mean difference in serum bilirubin level at different timing after start of phototherapy. It is also to determine the outcome of neonate who were treated with 360° phototherapy as compared to single surface LED phototherapy in term of the side effects or safety of the phototherapy, by monitoring of the temperature, hydration status, skin rashes, stool frequency and SPO2 monitoring, at the same time evaluating the ease of usage of 360° phototherapy device among the staff nurses in Neonatal Intensive Care Unit (NICU).
Trial website
Trial related presentations / publications
Public notes
Pre test validation has also be done prior to the study and validated by at least two consultant neonatologists prior to use,

Contacts
Principal investigator
Name 133038 0
Dr Nik Amalia binti Nik Najib
Address 133038 0
Pediatric Department, Hospital Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
Country 133038 0
Malaysia
Phone 133038 0
+60172935945
Fax 133038 0
Email 133038 0
malianajib@usm.my
Contact person for public queries
Name 133039 0
Nik Amalia binti Nik Najib
Address 133039 0
Pediatric Department, Hospital Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
Country 133039 0
Malaysia
Phone 133039 0
+60172935945
Fax 133039 0
Email 133039 0
malianajib@usm.my
Contact person for scientific queries
Name 133040 0
Nik Amalia binti Nik Najib
Address 133040 0
Pediatric Department, Hospital Universiti Sains Malaysia, 16150 Kubang Kerian, Kelantan
Country 133040 0
Malaysia
Phone 133040 0
+60172935945
Fax 133040 0
Email 133040 0
malianajib@usm.my

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?

No Supporting Document Provided



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.