Back to resultsEffect of Repositioning Frequency Neonates Receiving Phototherapy
Primary Purpose
Bilirubinemia, Newborn Jaundice
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Supine position group
Hourly position change group
Control Group (2-hour position change)
Sponsored by
About this trial
This is an interventional supportive care trial for Bilirubinemia focused on measuring bilirubin, comfort, neonates, phototherapy, positioning
Eligibility Criteria
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
Sites / Locations
- Selcuk University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Supine position group
Hourly position change group:
Control Group (2-hour position change)
Arm Description
These neonates were placed in supine position, fed every 2 hours in accordance with routine clinical practice, and then returned to supine position.
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.
Neonates in this group were repositioned every 2 hours as routine practice based on the time of phototherapy initiation.
Outcomes
Primary Outcome Measures
Change in bilirubin level
bilirubin level change
comfort level questionnaire
comfort level change
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05692648
Brief Title
Effect of Repositioning Frequency Neonates Receiving Phototherapy
Official Title
Effect of Repositioning Frequency on Bilirubin Level and Infant Comfort in Neonates Receiving Phototherapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Purpose: The present study was conducted to determine the effect of repositioning frequency during phototherapy on bilirubin level and neonates comfort.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilirubinemia, Newborn Jaundice
Keywords
bilirubin, comfort, neonates, phototherapy, positioning
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single-centered, single-blind, 3-arm, pretest-posttest parallel-group randomized controlled trial
Masking
Participant
Masking Description
single (participant, outcomes assessor)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supine position group
Arm Type
Experimental
Arm Description
These neonates were placed in supine position, fed every 2 hours in accordance with routine clinical practice, and then returned to supine position.
Arm Title
Hourly position change group:
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group (2-hour position change)
Arm Type
Other
Arm Description
Neonates in this group were repositioned every 2 hours as routine practice based on the time of phototherapy initiation.
Intervention Type
Behavioral
Intervention Name(s)
Supine position group
Intervention Description
These neonates were placed in supine position, fed every 2 hours in accordance with routine clinical practice, and then returned to supine position.
Intervention Type
Behavioral
Intervention Name(s)
Hourly position change group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Group (2-hour position change)
Intervention Description
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 Outcome Measure Information:
Title
Change in bilirubin level
Description
bilirubin level change
Time Frame
Baseline and 24 hours after phototherapy
Title
comfort level questionnaire
Description
comfort level change
Time Frame
up to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sibel Kücükoglu, professor
Organizational Affiliation
Selcuk University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fatma Tas Arslan, professor
Organizational Affiliation
Selcuk University
Official's Role
Study Director
Facility Information:
Facility Name
Selcuk University
City
Konya
State/Province
Selcuklu/Konya
ZIP/Postal Code
42060
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Repositioning Frequency Neonates Receiving Phototherapy
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