Effectiveness of the blanket model of light emitting diode “BLUI blanket” phototherapy on decreasing serum bilirubin levels in physiological jaundice at gestational age ≥ 35 weeks
| ISRCTN | ISRCTN17473621 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17473621 |
- Submission date
- 15/05/2023
- Registration date
- 06/06/2023
- Last edited
- 06/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Neonatal jaundice is a condition where newborns have high levels of bilirubin in their blood, which can be caused by various factors. In Indonesia, the prevalence of jaundice in newborns is relatively high. Current therapies for jaundice often involve conventional phototherapy tools, which have limitations such as separating the mother and baby, hindering breastfeeding, and being less portable.
One alternative is phototherapy blankets, which provide comfort and bonding between the baby and mother, as well as ease of direct breastfeeding. However, existing phototherapy blankets can be expensive. Recent research has focused on developing a simpler and more cost-effective phototherapy blanket using LED arrays. Studies have shown that LED lamps can effectively reduce bilirubin levels compared to conventional fluorescent lamps.
The BLUI Blanket LED phototherapy blanket is an LED-based alternative that has advantages such as lower production costs, easy portability, even radiation distribution, and flexibility in placement. This study aims to develop and evaluate the efficacy and side effects of the BLUI Blanket LED phototherapy blanket compared to conventional phototherapy devices. A randomized controlled trial will be conducted to assess the effectiveness of the new blanket in reducing bilirubin levels in newborns with physiological jaundice.
The goal is to compare the effects of the LED BLUI Blanket phototherapy blanket with traditional phototherapy devices in newborns at 35 weeks gestation who have physiological jaundice. The findings from this study will provide valuable insights into the effectiveness of LED phototherapy blankets and their potential to improve the treatment of neonatal jaundice.
Who can participate?
Infants with a gestational age ≥ 35 weeks and a postnatal age > 24 hours – 14 days with a birth weight ≥ 2000 grams
What does the study involve?
Eligibility and Consent – After receipt of a serum bilirubin level near or above the treatment line when compared with age on an appropriate treatment nomogram, the parents or guardians of the infant will be approached for informed consent by a member of the research team or a neonatal doctor. The investigator will explain the study fully to the patient’s parent(s)/guardian(s) using the Patient Information Sheet. Parents will be informed that they may withdraw their child from the study at any time should they wish; and that a decision not to consent to their child’s participation in the study or to withdraw their infant from the study once enrolled will not affect their infant's access to the best available care at the RSAB Harapan Kita. Consent forms will be kept securely, and a copy will be provided in the patient’s chart. Fully informed written consent will be obtained before enrolment.
Randomisation and Allocation Concealment - Randomisation will occur on receipt of informed consent. A computer-generated random number list will be used, prepared by an investigator with no clinical involvement in the trial. Sequences will be grouped based on the type of phototherapy used - BLUI Blanket and conventional (fluorescent) phototherapy. Once generated, the randomization lists will be sealed in opaque envelopes. Once the patient consents to enter the trial, the investigator(s), doctor on duty, or ANP will open the next sequential opaque envelope in the correct strata and provide the allocated interventions.
Blinding – Blinding of parents or research staff will not be possible due to the nature of the intervention.
Methods
Infants will be randomized after having a serum bilirubin sample that is ‘near’ the treatment line for their age or less from the treatment line on a treatment nomogram. Both groups will have serum bilirubin samples taken 24 hours until they cross the treatment line and require phototherapy or until they are deemed to be at a safe level from the line and suitable for discharge home. Infants in the control group may also be discharged for repeat samples as an outpatient if deemed appropriate.
Confidentiality
The study team will record data that is routinely collected for each infant in their medical records as part of their routine care. Participation in the study will not necessitate extra investigations or interventions over and above those indicated as part of their routine care. These data will be recorded on dedicated Case Report Forms (CRFs). These CRFs will not contain identifying information of individual infants and will be stored securely. Data that are extracted from these CRFs will be anonymized and entered into databases on password-protected computers.
What are the possible benefits and risks of participating?
An anticipated benefit for the patient's parents is that breast milk can be provided directly to the patient while using the phototherapy blanket.
The benefits for Society include:
- The results of this study can be applied to improve health services for the community, namely in the form of maintaining the bonding between mothers and babies who experience neonatal jaundice, where undergoing phototherapy between mothers and children are not separated.
- Maintain mother-infant contact and do not interfere with direct breastfeeding when the baby receives light therapy.
- Get cheap and affordable phototherapy.
The benefits for General Practitioner Clinicians and Pediatricians include:
- Providing evidence-based information to clinicians that Light Emitting Diode BLUI Blanket phototherapy blankets can be a more practical alternative to reducing bilirubin levels in neonatal jaundice and provide benefits for maintaining mother-infant contact when breastfeeding directly.
- Providing evidence-based information to clinicians that this BLUI Blanket Light Emitting Diode phototherapy blanket has milder side effects.
There is a risk that the phototherapy blanket will not work due to technical problems meaning that phototherapy rays will not perform their function optimally, causing ineffectiveness in lowering bilirubin levels.
Where is the study run from?
Univeritas Indonesia (Indonesia)
When is the study starting and how long is it expected to run for?
February 2020 to May 2024
Who is funding the study?
Education Fund Management Institute, Indonesia Endowment Fund for Education, LPDP (Indonesia)
Who is the main contact?
Tubagus Ferdi Fadilah, tubagus.ferdi@ui.ac.id (Indonesia)
Contact information
Public
Universitas Trisakti
Faculty of Medicine
Jakarta
11440
Indonesia
 ORCID ID |
0000-0001-8156-4876 |
|---|---|
| Phone | +62 21 566 3232 |
| tubagus.ferdi@ui.ac.id |
Study information
| Study design | Single-center two-armed randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | The effectiveness of the “BLUI Blanket” light emitting diode phototherapy blanket model against decreased bilirubin in physiological jaundice gestational age ≥ 35 Weeks - a randomised control trial |
| Study objectives | The proportion of physiologic jaundice neonates whose bilirubin levels decreased by or more than 3 mg/dL from the initial bilirubin level within 24 hours of neonates receiving therapy with LED BLUI blankets will be greater than the proportion of neonates receiving therapy with fluorescent phototherapy. |
| Ethics approval(s) | Approved 23/02/2023, Research and Community Engagement Ethical Committee, Faculty of Public Health at The University of Indonesia (Gedung Dekanat Fakultas Kesehatan Masyarakat Kampus UI Depok, 16424, Indonesia; +62 21 7864975, 7864976; fkmui@ui.ac.id), ref: Ket- 38/UN2.F10.D11/PPM.00.02/2023 |
| Health condition(s) or problem(s) studied | Neonatal jaundice |
| Intervention | The trial is a single-center, two-armed, randomized controlled trial. The intervention group will be treated with a BLUI Blanket in the post-natal ward. The control group will have conventional phototherapy (fluorescent overhead lamp). Both groups will be monitored for serum bilirubin levels for 24 hours until they reach a safe level for their age and gestation. A safe level is a serum bilirubin level below the treatment line. Ethical approval has been sought from the Research Ethics Committee in the Faculty of Public Health, Universitas Indonesia. Sample Recruitment Method The data collection procedure is carried out through the following steps: - Pass the ethics test from the FKM UI Ethics Committee - Pre-recruitment 1. Apply for a research permit from the Director of Harapan Kita Hospital. 2. Research respondents who met the requirements according to the inclusion criteria and exclusion criteria were then taken as research samples with the 4-block model 3. In this study the researchers were assisted by data collectors, namely the head of each inpatient room and nurse in the nursery or perinatology room, who had received instructions about the research objectives and ways to fill out questionnaires and collect data so that they had the same understanding. This activity was carried out for one day in the form of explanations, discussions and questions and answers. Recruitment 1. Researchers and data collectors meet the parents/guardians of the respondents and explain the purpose and benefits of the research to the parents/guardians of the respondents. After the parent/guardian of the respondent understood the explanation given, the parent/guardian of the respondent was asked for his consent by signing an informed consent as proof. 2. 100 eligible patients were then randomly allocated according to the randomization carried out by the Diklit section without the knowledge of the researchers, blocks were then allocated as patients with interventions and patients with controls. 3. Patients were followed from the start of phototherapy until the phototherapy was discontinued according to medical indications, and data was collected according to the research variables. 4. Blood samples are taken before the intervention (initial), 24 hours, and 48 hours from the start of phototherapy until the bilirubin level reaches the limit allowed to go home by the doctor in charge, namely total serum bilirubin level </=10 mg/dl for late preterm age gestation 35 – 36 6/7 weeks and </=12 mg/dl for term gestational age >/=37 weeks, and at discharge. 5. Conduct in-depth interviews and surveys with informants, namely doctors, nurses, and parents of patients after the patient has completed phototherapy. The intervention and timepoints The intervention group received a Light Emitting Diode BLUI Blanket phototherapy blanket and the control group received fluorescent phototherapy. The intervention provider Phototherapy is given by a perinatology nurse who has previously been given training on how to use the tool Mode of intervention delivery Phototherapy intervention is given directly to the individual |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | BLUI Blanket |
| Primary outcome measure | Bilirubin serum level measured by examination of blood serum at 24 hours after the start of phototherapy |
| Secondary outcome measures | Side effects measured by physical examination at 24 hours after the start of phototherapy |
| Overall study start date | 01/02/2020 |
| Completion date | 01/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Lower age limit | 2 Days |
| Upper age limit | 14 Days |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Infants with gestational age ≥ 35 weeks and birth weight ≥ 2000 grams (p25) 2. Postnatal age > 24 hours – 14 days 3. No history of birth trauma/cephalhematoma/bleeding 4. Total serum bilirubin levels are 10 and less than19 mg/dl (cut-off value for medium risk infants, gestational age 35-36 6/7 weeks and fit), and radar serum bilirubin total 12 less 22 mg/dl (limit value lower risk infants aged ≥ 38 weeks and fit) 5. Asian race 6. No circulatory disturbances, respiratory disorders, and saturation above 90% 7. The patient's parents/guardians agree to participate in the study and sign an informed consent |
| Key exclusion criteria | 1. Genetic, metabolic disorders, hemolytic anemia (examination of GDS levels, blood group, and rhesus, peripheral blood picture) 2. Infection (clinical fever or hypothermia and increased leukocyte laboratory tests) 3. The direct bilirubin level exceeds 2 mg/dl or 20% of the total serum bilirubin level |
| Date of first enrolment | 01/05/2023 |
| Date of final enrolment | 01/02/2024 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Jakarta
11420
Indonesia
Sponsor information
Government
Indonesia Endowment Fund for Education
Gedung Danadyaksa Cikini
Jl. Cikini Raya No.91A-D
Menteng
Jakarta Pusat
10330
Indonesia
| Phone | +62 21 23507011 |
|---|---|
| kemenkeu.prime@kemenkeu.go.id | |
| Website | https://lpdp.kemenkeu.go.id/en/informasi/hubungi-kami/ |
"ROR" |
https://ror.org/05p2xef58 |
Funders
Funder type
Government
Government organisation / Universities (academic only)
- Alternative name(s)
- Education Fund Management Institute, Indonesia Endowment Fund for Education, LPDP
- Location
- Indonesia
Results and Publications
| Intention to publish date | 01/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated or analyzed during the current study will be published as a supplement to the result publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 31/05/2023 | No | No |
Additional files
Editorial Notes
06/06/2023: Trial's existence confirmed by the Research and Community Engagement Ethical Committee Faculty of Public Health Universitas Indonesia.
