Effect of Repositioning Frequency Neonates Receiving Phototherapy

NCT05692648 | Completed

• 1 other identifier: 2019/14489
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bilirubinemia; Newborn Jaundice

Keywords

bilirubin; comfort; neonates; phototherapy; positioning

Outcome Measures

Primary Outcomes (2)

• Change in bilirubin level

  bilirubin level change

  Baseline and 24 hours after phototherapy

• comfort level questionnaire

  comfort level change

  up to 24 hours

Study Arms (3)

Supine position group

EXPERIMENTAL

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

Hourly position change group:

EXPERIMENTAL

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

Control Group (2-hour position change)

OTHER

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)

Interventions

Supine position group BEHAVIORAL

These neonates were placed in supine position, fed every 2 hours in accordance with routine clinical practice, and then returned to supine position.

Supine position group

Hourly position change group BEHAVIORAL

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.

Hourly position change group:

Control Group (2-hour position change) BEHAVIORAL

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.

Control Group (2-hour position change)

Eligibility Criteria

• Age: 35 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Selcuklu/Konya, 42060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hyperbilirubinemia; Jaundice, Neonatal

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sibel Kücükoglu, professor

  Selcuk University

  STUDY DIRECTOR

• Fatma Tas Arslan, professor

  Selcuk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single (participant, outcomes assessor)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer (Phd)

Model Details: single-centered, single-blind, 3-arm, pretest-posttest parallel-group randomized controlled trial

Study Record Dates

• First Submitted: December 31, 2022
• First Posted: January 20, 2023
• Study Start: February 1, 2020
• Primary Completion: August 30, 2020
• Study Completion: September 30, 2020
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)