Aluminum Foil Reflector on Phototherapy for Newborn with Jaundice (NCT06837935) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Aluminum Foil Reflector on Phototherapy for Newborn with Jaundice
Taiwan160 participantsStarted 2025-05-01
Plain-language 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. 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.
Who can participate
Age range
1 Hour – 14 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Infants with serum bilirubin levels close to the exchange transfusion limit
. Hemolytic disease (Ex: G6PD)
. Congenital anomalies
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Decline in bilirubin
Timeframe: at 24 hours, 48 hours, 72 hours and the end of phototherapy
2
Phototherapy duration (hours)
Timeframe: From the date of beginning of phototherapy until the day of stop of phototherapy
Trial details
NCT IDNCT06837935
SponsorTaipei Medical University Shuang Ho Hospital