Newborn JaundiceNCT06837935
Aluminum Foil Reflector on Phototherapy for Newborn with Jaundice
A study testing Aluminum Foil Reflector in people with Newborn Jaundice, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
Hyperbilirubinemia is defined as the presence of bilirubin in the serum of newborns at levels exceeding the normal range. It is the most common problem among healthy newborns, with an incidence of approximately 40% to 60% in full-term infants. Read more about this study
- Who is it for?
- Ages 1 hour to 14 days
- Conditions the study is for
- Newborn Jaundice
- What is being tested?
- Aluminum Foil Reflector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns who are admitted to the neonatal ward for examination and treatment due to jaundice levels reaching the treatment threshold.
- Term babies below 14 days of age (gestational age of 37 weeks or greater).
- No evidence of hemolysis
Who cannot join
- Infants with serum bilirubin levels close to the exchange transfusion limit
- Hemolytic disease (Ex: G6PD)
- Congenital anomalies
- Elevated direct bilirubin
- Infants with abnormal liver function or biliary structure
- Infants who receive Cardiopulmonary Resuscitation after birth or suspected perinatal asphyxia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Shuangho Hospital
New Taipei City
SunPeng Chang, 0912028058, 09055@s.tmu.edu.tw
About this study
Official title: Effect of Aluminum Foil Reflector on Phototherapy for Newborn Infants with Unconjugated Hyperbilirubinemia: a Randomized Controlled Trial
Hyperbilirubinemia is defined as the presence of bilirubin in the serum of newborns at levels exceeding the normal range. It is the most common problem among healthy newborns, with an incidence of approximately 40% to 60% in full-term infants. The primary cause is the immature bilirubin metabolism in newborns, leading to the accumulation of excess bilirubin in the blood, which in turn results in a temporary yellowing of the skin and sclera, known as jaundice. Physiological jaundice in full-term newborns typically appears 24 to 72 hours after birth, peaking on days 4 to 5. Studies have shown that neonatal jaundice is a leading cause of readmission after discharge.
Phototherapy is the most effective and safest treatment for neonatal hyperbilirubinemia. It takes advantage of bilirubin's sensitivity to light, converting bilirubin into water-soluble conjugated bilirubin, which is then excreted through bile and urine, thereby reducing total bilirubin levels. The most effective light during phototherapy has a wavelength of 400 nm to 520 nm and an intensity of at least 30 microW/cm²/nm, with at least 80% of the infant's body surface area exposed.
This study aims to investigate whether using aluminum foil reflective covering around the phototherapy incubator can enhance the effectiveness of light treatment for jaundice in infants, thus potentially reducing the duration of phototherapy required.
- Conditions
- Newborn Jaundice
- Being tested
- Aluminum Foil Reflector
- Keywords
- Aluminum Foil Reflector, Phototherapy, Newborn, Hyperbilirubinemia
- Medical subject headings
- Jaundice, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aluminum Foil ReflectorDevice
The hyperbilirubinemia newborns will receive phototherapy with an Aluminum Foil Reflector around an incubator. The aluminum foil reflector, sewn inside a cloth that is 30 cm long and 3 mm thick, will be hung from the three sides of the phototherapy unit. The reflector will cover the whole incubator except for the foot part to allow infant observation during treatment. While receiving phototherapy, the lights will be continuously on, except during feeding, physical examination, and blood taking. All participants will dress only in nappies and eye masks during phototherapy treatment.
Serum bilirubin will be taken every 24 hours until phototherapy can be stopped according to AAP guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Aluminum Foil Reflector Group | Experimental | This group includes newborns who require phototherapy with an Aluminum Foil Reflector. Receives: Device: Aluminum Foil Reflector |
| Control group | No intervention | This group includes newborns requiring phototherapy and not using an Aluminum Foil Reflector. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decline in bilirubin
The number of infants experiencing sufficient decline in bilirubin.
Measured: at 24 hours, 48 hours, 72 hours and the end of phototherapy
Phototherapy duration (hours)
The total time of phototherapy, mean ± SD
Measured: From the date of beginning of phototherapy until the day of stop of phototherapy
Secondary outcomes (4)
Bilirubinemia concentration
Heel blood will be taken for serum bilirubin level assessment
Measured: At 24 hours, 48 hours, 72 hours and the end of phototherapy
Hospital stay (days)
Number of days of hospital stay
Measured: From the hospitalization to the discharge of infants
Skin rash
Number of participants with redness, blisters, itchiness, and peeling.
Measured: From the beginning of phototherapy until the stop of phototherapy.
Diarrhea
Number of participants having the signs of passing loose, watery stools three or more times a day
Measured: From the beginning of phototherapy until the stop of phototherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn JaundiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ka-Wai Tam, Study director, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837935
- Sponsor's protocol ID
- N202411028
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aluminum Foil Reflector on Phototherapy for Newborn Infants with Unconjugated Hyperbilirubinemia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06837935
- Acronym / sponsor ID
- N202411028
- Conditions
- Newborn Jaundice
- Keywords
- Aluminum Foil Reflector, Phototherapy, Newborn, Hyperbilirubinemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hyperbilirubinemia is defined as the presence of bilirubin in the serum of newborns at levels exceeding the normal range. It is the most common problem among healthy newborns, with an incidence of approximately 40% to 60% in full-term infants. The primary cause is the immature bilirubin metabolism in newborns, leading to the accumulation of excess bilirubin in the blood, which in turn results in a temporary yellowing of the skin and sclera, known as jaundice. Physiological jaundice in full-term newborns typically appears 24 to 72 hours after birth, peaking on days 4 to 5. Studies have shown that neonatal jaundice is a leading cause of readmission after discharge.
Phototherapy is the most effective and safest treatment for neonatal hyperbilirubinemia. It takes advantage of bilirubin's sensitivity to light, converting bilirubin into water-soluble conjugated bilirubin, which is then excreted through bile and urine, thereby reducing total bilirubin levels. The most effective light during phototherapy has a wavelength of 400 nm to 520 nm and an intensity of at least 30 microW/cm²/nm, with at least 80% of the infant's body surface area exposed.
This study aims to investigate whether using aluminum foil reflective covering around the phototherapy incubator can enhance the effectiveness of light treatment for jaundice in infants, thus potentially reducing the duration of phototherapy required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Aluminum Foil Reflector Group | Experimental | Device: Aluminum Foil ReflectorThis group includes newborns who require phototherapy with an Aluminum Foil Reflector. |
| Control group | No intervention | –This group includes newborns requiring phototherapy and not using an Aluminum Foil Reflector. |
Who may qualify
- Ages
- 1 hour to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborns who are admitted to the neonatal ward for examination and treatment due to jaundice levels reaching the treatment threshold.
- Term babies below 14 days of age (gestational age of 37 weeks or greater).
- No evidence of hemolysis
Key exclusion criteria (6 listed)
- Infants with serum bilirubin levels close to the exchange transfusion limit
- Hemolytic disease (Ex: G6PD)
- Congenital anomalies
- Elevated direct bilirubin
- Infants with abnormal liver function or biliary structure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aluminum Foil ReflectorThe hyperbilirubinemia newborns will receive phototherapy with an Aluminum Foil Reflector around an incubator. The aluminum foil reflector, sewn inside a cloth that is 30 cm long and 3 mm thick, will be hung from the three sides of the phototherapy unit. The reflector will cover the whole incubator except for the foot part to allow infant observation during treatment. While receiving phototherapy, the lights will be continuously on, except during feeding, physical examination, and blood taking. All participants will dress only in nappies and eye masks during phototherapy treatment. Serum bilirubin will be taken every 24 hours until phototherapy can be stopped according to AAP guidelines. | Device | Aluminum Foil Reflector Group |
Primary outcome
Decline in bilirubin
Time frame: at 24 hours, 48 hours, 72 hours and the end of phototherapy
The number of infants experiencing sufficient decline in bilirubin.
Phototherapy duration (hours)
Time frame: From the date of beginning of phototherapy until the day of stop of phototherapy
The total time of phototherapy, mean ± SD
4 secondary outcomes
Bilirubinemia concentration
Time frame: At 24 hours, 48 hours, 72 hours and the end of phototherapy
Hospital stay (days)
Time frame: From the hospitalization to the discharge of infants
Skin rash
Time frame: From the beginning of phototherapy until the stop of phototherapy.
Diarrhea
Time frame: From the beginning of phototherapy until the stop of phototherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Newborn Jaundice
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Newborn Abdominal Massage to Prevent Hyperbilirubinemia
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Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
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Not yet recruitingPhase 4
Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
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Enrolling by invitation
Hat-Type Glasses Intervention in Phototherapy-Related Newborns
Neonatal Hyperbilirubinemia, Neonatal Jaundice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ka-Wai Tam study director
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aluminum Foil Reflector in people with Newborn Jaundice, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SunPeng Chang (+886-2249-0088 ext. 2660, 09055@s.tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decline in bilirubin (time frame: at 24 hours, 48 hours, 72 hours and the end of phototherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.