Aluminum Foil Reflector on Phototherapy for Newborn with Jaundice
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aluminum Foil Reflector.
- Who it may be relevant to
- Registry conditions: Newborn Jaundice. Basic parameters: 1 Hour — 14 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Aluminum Foil Reflector on Phototherapy for Newborn Infants with Unconjugated Hyperbilirubinemia: a Randomized Controlled Trial
Overview
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.
Interventions
- Device Aluminum Foil Reflector
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.
Primary outcome measures
- Decline in bilirubin [Time frame: at 24 hours, 48 hours, 72 hours and the end of phototherapy]
- Phototherapy duration (hours) [Time frame: From the date of beginning of phototherapy until the day of stop of phototherapy]
Secondary outcome measures (4)
- 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.]
Eligibility criteria
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
- Elevated direct bilirubin
- Infants with abnormal liver function or biliary structure
- Infants who receive Cardiopulmonary Resuscitation after birth or suspected perinatal asphyxia
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Shuangho Hospital — New Taipei City
Identifiers
NCT: NCT06837935 · N202411028