Clinical trial NCT06837935: Aluminum Foil Reflector on Phototherapy for Newborn with Jaundice
Official title: Effect of Aluminum Foil Reflector on Phototherapy for Newborn Infants with Unconjugated Hyperbilirubinemia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Newborn Jaundice
Keywords: Aluminum Foil Reflector
Phototherapy
Newborn
Hyperbilirubinemia
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 160
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Decline in bilirubin
timeFrame: at 24 hours, 48 hours, 72 hours and the end of phototherapy
measure: Phototherapy duration (hours)
timeFrame: From the date of beginning of phototherapy until the day of stop of phototherapy
Secondary outcomes:
measure: Bilirubinemia concentration
timeFrame: At 24 hours, 48 hours, 72 hours and the end of phototherapy
measure: Hospital stay (days)
timeFrame: From the hospitalization to the discharge of infants
measure: Skin rash
timeFrame: From the beginning of phototherapy until the stop of phototherapy.
measure: Diarrhea
timeFrame: From the beginning of phototherapy until the stop of phototherapy.
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Shuangho Hospital
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: Ka-Wai Tam
role: STUDY_DIRECTOR
References: