Aluminum Foil Reflector on Phototherapy for Newborn with Jaundice

NCT06837935 | Not Yet Recruiting DMC

• 1 other identifier: N202411028
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborn Jaundice

Keywords

Aluminum Foil Reflector; Phototherapy; Newborn; Hyperbilirubinemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Bilirubinemia concentration

  At 24 hours, 48 hours, 72 hours and the end of phototherapy

• Hospital stay (days)

  From the hospitalization to the discharge of infants

• Skin rash

  From the beginning of phototherapy until the stop of phototherapy.

• Diarrhea

  From the beginning of phototherapy until the stop of phototherapy.

Study Arms (2)

Aluminum Foil Reflector Group

EXPERIMENTAL

This group includes newborns who require phototherapy with an Aluminum Foil Reflector.

Device: Aluminum Foil Reflector

Control group

NO INTERVENTION

This group includes newborns requiring phototherapy and not using an Aluminum Foil Reflector.

Interventions

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.

Aluminum Foil Reflector Group

Eligibility Criteria

• Age: 1 Hour - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Shuangho Hospital

New Taipei City, Taiwan

Location

MeSH Terms

Conditions

Jaundice, Neonatal; Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ka-Wai Tam

  Taipei Medical University Shuang Ho Hospital

  STUDY DIRECTOR

Central Study Contacts

SunPeng Chang

CONTACT

+886-2249-0088; 09055@s.tmu.edu.tw

Le Thy Phuong Anh

CONTACT

+886-987133290; d142113019@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 20, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)