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Completed

NCT Number: NCT05692648

Effect of Repositioning Frequency 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.

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Key information

Conditions

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

Age range

35 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University

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

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Change in bilirubin level

    Time frame: Baseline and 24 hours after phototherapy

    bilirubin level change

  2. comfort level questionnaire

    Time frame: up to 24 hours

    comfort level change

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 20, 2023
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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