Aluminum Foil Reflector on Phototherapy for Newborn with Jaundice

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-14
SponsorTaipei Medical University Shuang Ho Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Infants with serum bilirubin levels close to the exchange transfusion limit

Hemolytic disease (Ex: G6PD)

Congenital anomalies

Elevated direct bilirubin

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aluminum Foil Reflector

    Device

    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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Aluminum Foil Reflector GroupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

Hospital stay (days)

Number of days of hospital stay

Time frame
From the hospitalization to the discharge of infants
3

Skin rash

Number of participants with redness, blisters, itchiness, and peeling.

Time frame
From the beginning of phototherapy until the stop of phototherapy.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: