Effect of Repositioning Frequency Neonates Receiving Phototherapy

Newborn Jaundice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05692648
• Other study ID #: 2019/14489
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: January 2023
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Weeks to 42 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Bilirubinemia
• Hyperbilirubinemia
• Jaundice
• Jaundice, Neonatal

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Selcuk University	Konya	Selcuklu/Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bilirubin level	bilirubin level change	Baseline and 24 hours after phototherapy
Primary	comfort level questionnaire	comfort level change	up to 24 hours