An interventional study of Aluminum Foil Reflector in Newborn Jaundice, sponsored by Taipei Medical University Shuang Ho Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 1 Hour to 14 Days. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by Taipei Medical University Shuang Ho Hospital · Not applicable, Interventional, and Treatment
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.
110 studies on the registry are indexed under Jaundice, Neonatal; 28 are open to participants now.
This study's planned enrollment of 160 is close to the median of 150 across 78 interventional studies indexed under Jaundice, Neonatal.
Browse Jaundice, Neonatal studies →Taipei Medical University Shuang Ho Hospital is the lead sponsor of 102 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group includes newborns who require phototherapy with an Aluminum Foil Reflector.
Device: Aluminum Foil Reflector
This group includes newborns requiring phototherapy and not using an 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. 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.
Decline in bilirubin
The number of infants experiencing sufficient decline in bilirubin.
Time frame: at 24 hours, 48 hours, 72 hours and the end of phototherapy
Phototherapy duration (hours)
The total time of phototherapy, mean ± SD
Time frame: From the date of beginning of phototherapy until the day of stop of phototherapy
Bilirubinemia concentration
Heel blood will be taken for serum bilirubin level assessment
Time frame: At 24 hours, 48 hours, 72 hours and the end of phototherapy
Hospital stay (days)
Number of days of hospital stay
Time frame: From the hospitalization to the discharge of infants
Skin rash
Number of participants with redness, blisters, itchiness, and peeling.
Time frame: 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
Time frame: From the beginning of phototherapy until the stop of phototherapy.
Plan to share: No
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This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Taipei Medical University Shuang Ho Hospital →