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NCT Number: NCT06837935

Aluminum Foil Reflector on Phototherapy for Newborn with Jaundice

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.

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Key information

Age range

1 hour–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Infants with serum bilirubin levels close to the exchange transfusion limit
  • Hemolytic disease (Ex: G6PD)
  • Congenital anomalies
  • Elevated direct bilirubin
  • Infants with abnormal liver function or biliary structure
  • Infants who receive Cardiopulmonary Resuscitation after birth or suspected perinatal asphyxia

Treatment and study plan

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.

Primary outcomes

  1. Decline in bilirubin

    Time frame: at 24 hours, 48 hours, 72 hours and the end of phototherapy

    The number of infants experiencing sufficient decline in bilirubin.

  2. Phototherapy duration (hours)

    Time frame: From the date of beginning of phototherapy until the day of stop of phototherapy

    The total time of phototherapy, mean ± SD

Secondary outcomes

  1. Bilirubinemia concentration

    Time frame: At 24 hours, 48 hours, 72 hours and the end of phototherapy

    Heel blood will be taken for serum bilirubin level assessment

  2. Hospital stay (days)

    Time frame: From the hospitalization to the discharge of infants

    Number of days of hospital stay

  3. Skin rash

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

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

  4. Diarrhea

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Le Thy Phuong Anh

CONTACT

[email protected]

+886-987133290

SunPeng Chang

CONTACT

[email protected]

+886-2249-0088 ext. 2660

Sponsors and collaborators

Lead sponsor

Taipei Medical University Shuang Ho Hospital

Other

Registry information

Official study title

Effect of Aluminum Foil Reflector on Phototherapy for Newborn Infants with Unconjugated Hyperbilirubinemia: a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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