Effect of Repositioning Frequency Neonates Receiving Phototherapy

• Sponsor: Selcuk University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05692648
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Actual Duration (Months): 8
• Patients Per Site Per Month: 7.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bilirubinemia; Newborn Jaundice	Behavioral: Supine position group; Behavioral: Hourly position change group; Behavioral: Control Group (2-hour position change)	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: single-centered, single-blind, 3-arm, pretest-posttest parallel-group randomized controlled trialsingle-centered, single-blind, 3-arm, pretest-posttest parallel-group randomized controlled trial
• Masking: Single (Participant)
• Masking Description: single (participant, outcomes assessor)
• Primary Purpose: Supportive Care
• Official Title: Effect of Repositioning Frequency on Bilirubin Level and Infant Comfort in Neonates Receiving Phototherapy
• Actual Study Start Date: Feb 1, 2020
• Actual Primary Completion Date: Aug 30, 2020
• Actual Study Completion Date: Sep 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in bilirubin level [Baseline and 24 hours after phototherapy]

   bilirubin level change

2. comfort level questionnaire [up to 24 hours]

   comfort level change

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Weeks to 42 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Selcuk University	Konya	Selcuklu/Konya	Turkey	42060

Sponsors and Collaborators

• Selcuk University

Investigators

• Study Director: Sibel Kücükoglu, professor, Selcuk University
• Study Director: Fatma Tas Arslan, professor, Selcuk University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sevinc Akkoyun, lecturer (Phd), Selcuk University
• ClinicalTrials.gov Identifier: NCT05692648
• Other Study ID Numbers: 2019/14489
• First Posted: Jan 20, 2023
• Last Update Posted: Jan 20, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sevinc Akkoyun, lecturer (Phd), Selcuk University: bilirubin; comfort; neonates; phototherapy; positioning
• Additional relevant MeSH terms: Jaundice, Neonatal; Jaundice; Hyperbilirubinemia

Study Results

No Results Posted as of Jan 20, 2023