Effect of Repositioning Frequency Neonates Receiving Phototherapy

Effect of Repositioning Frequency on Bilirubin Level and Infant Comfort in Neonates Receiving Phototherapy

Purpose: The present study was conducted to determine the effect of repositioning frequency during phototherapy on bilirubin level and neonates comfort.

Design and methods: This was a single-centered, single-blind, 3-arm, pretest-posttest parallel-group randomized controlled trial conducted in a neonatal intensive care unit. Participants were randomly assigned to one of three groups: Supine position group (n = 20), hourly position change group (n = 20), and control group (n = 20). The bilirubin level and comfort levels of the neonates were evaluated.

Study Overview

• Status: Completed
• Conditions: Newborn Jaundice; Bilirubinemia
• Intervention / Treatment: Behavioral: Supine position group; Behavioral: Hourly position change group; Behavioral: Control Group (2-hour position change)

Detailed Description

Purpose: The present study was conducted to determine the effect of repositioning frequency during phototherapy on bilirubin level and neonates comfort.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Selcuklu/Konya
    • Konya, Selcuklu/Konya, Turkey, 42060
      • Selcuk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 9 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• gestational age between 35-42 weeks
• birth weight of 2000 g or more
• indication for phototherapy
• no previous phototherapy,
• no medical diagnosis other than prenatal hyperbilirubinemia
• stable health status
• no clinical signs of dehydration
• transition to oral feeding, no sucking problems
• being at least 2 days old on the day of phototherapy

Exclusion Criteria:

• a sudden change in stability during phototherapy and
• phototherapy duration of less than 24 hours

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supine position group; These neonates were placed in supine position, fed every 2 hours in accordance with routine clinical practice, and then returned to supine position.	Behavioral: Supine position group; These neonates were placed in supine position, fed every 2 hours in accordance with routine clinical practice, and then returned to supine position.
Experimental: Hourly position change group: Infants in this group were repositioned "every hour" based on the time of phototherapy initiation. Neonates were initially placed in supine position and then changed to the prone position. Infants were alternated between supine and prone positions every hour for 24 hours.	Behavioral: Hourly position change group; Infants in this group were repositioned "every hour" based on the time of phototherapy initiation. Neonates were initially placed in supine position and then changed to the prone position. Infants were alternated between supine and prone positions every hour for 24 hours.
Other: Control Group (2-hour position change); Neonates in this group were repositioned every 2 hours as routine practice based on the time of phototherapy initiation.	Behavioral: Control Group (2-hour position change); Neonates in this group were repositioned every 2 hours as routine practice based on the time of phototherapy initiation. Phototherapy was started with neonates in supine position. In the second period, the neonate was placed in the prone position after routine feeding was performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bilirubin level	bilirubin level change	Baseline and 24 hours after phototherapy
comfort level questionnaire	comfort level change	up to 24 hours

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Study Director: Fatma Taş Arslan, Professor, Selcuk University; Study Director: Sibel Kücükoglu, professor, Selcuk University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): August 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: December 31, 2022
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: comfort; phototherapy; neonates; positioning; bilirubin
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia, Neonatal; Jaundice; Hyperbilirubinemia; Jaundice, Neonatal
• Other Study ID Numbers: 2019/14489

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