Newborn Jaundice
Conditions
Keywords
Aluminum Foil Reflector, Phototherapy, Newborn, Hyperbilirubinemia
Brief 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.
Interventions
DEVICEAluminum 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.
Sponsors
Taipei Medical University Shuang Ho Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
1 Hours to 14 Days
Healthy volunteers
No
Inclusion criteria
1. Newborns who are admitted to the neonatal ward for examination and treatment due to jaundice levels reaching the treatment threshold. 2. Term babies below 14 days of age (gestational age of 37 weeks or greater). 3. No evidence of hemolysis
Exclusion criteria
1. Infants with serum bilirubin levels close to the exchange transfusion limit 2. Hemolytic disease (Ex: G6PD) 3. Congenital anomalies 4. Elevated direct bilirubin 5. Infants with abnormal liver function or biliary structure 6. Infants who receive Cardiopulmonary Resuscitation after birth or suspected perinatal asphyxia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decline in bilirubin | at 24 hours, 48 hours, 72 hours and the end of phototherapy | The number of infants experiencing sufficient decline in bilirubin. |
| Phototherapy duration (hours) | From the date of beginning of phototherapy until the day of stop of phototherapy | The total time of phototherapy, mean ± SD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bilirubinemia concentration | At 24 hours, 48 hours, 72 hours and the end of phototherapy | Heel blood will be taken for serum bilirubin level assessment |
| Hospital stay (days) | From the hospitalization to the discharge of infants | Number of days of hospital stay |
| Skin rash | From the beginning of phototherapy until the stop of phototherapy. | Number of participants with redness, blisters, itchiness, and peeling. |
| Diarrhea | 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 |
Countries
Taiwan
Contacts
Primary ContactSunPeng Chang
Backup ContactLe Thy Phuong Anh
Outcome results
None listed