Aluminum Foil Reflector on Phototherapy for Newborn with Jaundice

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

Study Overview

• Status: Not yet recruiting
• Conditions: Newborn Jaundice
• Intervention / Treatment: Device: Aluminum Foil Reflector

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SunPeng Chang; Phone Number: 2660 +886-2249-0088; Email: 09055@s.tmu.edu.tw
• Study Contact Backup: Name: Le Thy Phuong Anh; Phone Number: +886-987133290; Email: d142113019@tmu.edu.tw

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Shuangho Hospital
    • Contact: SunPeng Chang; Phone Number: 0912028058; Email: 09055@s.tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aluminum Foil Reflector Group; This group includes newborns who require phototherapy with an Aluminum Foil Reflector.	Device: 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.
No Intervention: Control group; This group includes newborns requiring phototherapy and not using an Aluminum Foil Reflector.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decline in bilirubin	The number of infants experiencing sufficient decline in bilirubin.	at 24 hours, 48 hours, 72 hours and the end of phototherapy
Phototherapy duration (hours)	The total time of phototherapy, mean ± SD	From the date of beginning of phototherapy until the day of stop of phototherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bilirubinemia concentration	Heel blood will be taken for serum bilirubin level assessment	At 24 hours, 48 hours, 72 hours and the end of phototherapy
Hospital stay (days)	Number of days of hospital stay	From the hospitalization to the discharge of infants
Skin rash	Number of participants with redness, blisters, itchiness, and peeling.	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	From the beginning of phototherapy until the stop of phototherapy.

Collaborators and Investigators

• Sponsor: Taipei Medical University Shuang Ho Hospital
• Investigators: Study Director: Ka-Wai Tam, Taipei Medical University Shuang Ho Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Newborn; Phototherapy; Hyperbilirubinemia; Aluminum Foil Reflector
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia, Neonatal; Jaundice, Neonatal; Jaundice; Hyperbilirubinemia
• Other Study ID Numbers: N202411028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No