Research Assistant

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Background: Indirect hyperbilirubinemia (IHB) is a common neonatal condition, affecting over 60% of term and 80% of preterm infants. Phototherapy is the most widely used, safe, and non-invasive treatment; however, scattering of phototherapy light decreases treatment efficacy, prolongs therapy duration, and increases the risk of side effects. Reflective materials have been suggested to enhance phototherapy effectiveness, yet studies comparing different reflector types remain limited. Aim: This study aims to compare the effects of using reflective materials (white cloth or aluminum foil) during phototherapy on total serum bilirubin levels, phototherapy duration, length of hospital stay, vital signs, side effects, and nurses' satisfaction in neonates with physiological IHB.

Methods: This single-center, single-blind, randomized controlled trial will be conducted at Ankara University Faculty of Medicine, Cebeci Neonatal Intensive Care Unit. A total of 81 neonates with gestational age 35-42 weeks and total serum bilirubin levels of 15-20 mg/dl will be randomly assigned into three groups: (1) phototherapy with white cloth reflectors, (2) phototherapy with aluminum foil reflectors, and (3) standard phototherapy (control). Data will be collected using an Introductory Information Form, Daily Follow-up Chart, Side Effect Observation Form, and Nurse Satisfaction Questionnaire. Statistical analyses will include parametric and non-parametric tests based on distribution assumptions, with significance set at p\<0.05. Expected

Results: It is hypothesized that the use of reflective materials will result in faster reduction of total serum bilirubin, shorter phototherapy and hospitalization durations, more stable vital signs, fewer side effects, and higher nurse satisfaction compared with standard phototherapy.

Conclusion: The study will provide evidence on the comparative effectiveness of two low-cost reflector materials in enhancing phototherapy outcomes, potentially offering a practical and efficient strategy for neonatal hyperbilirubinemia management.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8 months
Maximum Age: 9 months
Healthy Volunteers: f
View:

• Neonates with total serum bilirubin levels between 15-20 mg/dL

• Gestational age between 35-42 weeks

• Birth weight between 2500-4000 g

• APGAR score of 7-10 at the 1st and 5th minutes after birth

• Fed with breast milk and/or formula

• Written and verbal informed consent obtained from parents

• Neonates who can be reached on the first day of phototherapy treatment

Locations
Other Locations
Turkey
Ankara Bilkent City Hospital
RECRUITING
Ankara
Contact Information
Primary
Kübra Nur Kabakcı Sarıdağ
kubranurkabakci@gmail.com
+905079149033
Backup
Figen Isık Esenay
Figen.Isik.Esensoy@ankara.edu.tr
+905326869514
Time Frame
Start Date: 2024-12-30
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 27
Treatments
Experimental: Group using a white sheet as reflective material in conjunction with phototherapy
The three sides of the incubator will be covered with a cardboard panel, cut to fit the incubator dimensions, lined with white linen cloth on the inner surface (length 88 cm, width 47 cm, height 34 cm).
Experimental: Group Using Aluminum Foil as Reflective Material in Combination with Phototherapy
The incubators will be enclosed by a panel covered with aluminum foil on three sides (long side 88 cm, short side 47 cm, height 34 cm).
No_intervention: Group Receiving Standard Single Phototherapy
Infants will receive treatment in accordance with standard phototherapy practice.
Sponsors
Leads: Baskent University

This content was sourced from clinicaltrials.gov