Shuangho Hospital
New Taipei City, Taiwan
NCT Number: NCT06837935
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.
Trial opening soon.
Get Notified1 hour–14 day
All sexes
Interventional
Not applicable
New Taipei City, Taiwan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: at 24 hours, 48 hours, 72 hours and the end of phototherapy
The number of infants experiencing sufficient decline in bilirubin.
Time frame: From the date of beginning of phototherapy until the day of stop of phototherapy
The total time of phototherapy, mean ± SD
Time frame: At 24 hours, 48 hours, 72 hours and the end of phototherapy
Heel blood will be taken for serum bilirubin level assessment
Time frame: From the hospitalization to the discharge of infants
Number of days of hospital stay
Time frame: From the beginning of phototherapy until the stop of phototherapy.
Number of participants with redness, blisters, itchiness, and peeling.
Time frame: From the beginning of phototherapy until the stop of phototherapy.
Number of participants having the signs of passing loose, watery stools three or more times a day
Contact information is provided by the study sponsor or research team.
Taipei Medical University Shuang Ho Hospital
Other
Effect of Aluminum Foil Reflector on Phototherapy for Newborn Infants with Unconjugated Hyperbilirubinemia: a Randomized Controlled Trial
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