BilirubinemiaNCT05692648
Effect of Repositioning Frequency Neonates Receiving Phototherapy
A study testing Supine position group and Hourly position change group in people with Bilirubinemia and Newborn Jaundice, run by Selcuk University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 35 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Bilirubinemia, Newborn Jaundice
- What is being tested?
- Supine position group and Hourly position change group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 9Show fewer
- no clinical signs of dehydration
- transition to oral feeding, no sucking problems
- being at least 2 days old on the day of phototherapy
Who cannot join
- a sudden change in stability during phototherapy and
- phototherapy duration of less than 24 hours
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University
Konya, Selcuklu/Konya, 42060
About this study
Official title: Effect of Repositioning Frequency on Bilirubin Level and Infant Comfort in 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.
Read the detailed description
Purpose: The present study was conducted to determine the effect of repositioning frequency during phototherapy on bilirubin level and neonates comfort.
- Conditions
- Bilirubinemia, Newborn Jaundice
- Being tested
- Supine position group, Hourly position change group, Control Group (2-hour position change)
- Keywords
- bilirubin, comfort, neonates, phototherapy, positioning
- Medical subject headings
- Hyperbilirubinemia, Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine position groupBehavioural
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 groupBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Control Group (2-hour position change) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bilirubin level
bilirubin level change
Measured: Baseline and 24 hours after phototherapy
comfort level questionnaire
comfort level change
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start1 Feb 2020
- Primary completion30 Aug 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BilirubinemiaStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-centered, single-blind, 3-arm, pretest-posttest parallel-group randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevinc Akkoyun, Selcuk University
- Investigators
- Sibel Kücükoglu, professor, Study director, Selcuk UniversityFatma Tas Arslan, professor, Study director, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692648
- Sponsor's protocol ID
- 2019/14489
- Other IDs
- 2019
- Status last verified
- Jan 2023
- First submitted
- 31 Dec 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repositioning Frequency on Bilirubin Level and Infant Comfort in Neonates Receiving Phototherapy
- ClinicalTrials.gov ID
- NCT05692648
- Acronym / sponsor ID
- 2019/14489
- Conditions
- Bilirubinemia, Newborn Jaundice
- Keywords
- bilirubin, comfort, neonates, phototherapy, positioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- single-centered, single-blind, 3-arm, pretest-posttest parallel-group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Supine position group | Experimental | Behavioral: Supine position groupThese 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: | Experimental | Behavioral: Hourly position change groupInfants 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) | Other | 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. |
Who may qualify
- Ages
- 35 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- a sudden change in stability during phototherapy and
- phototherapy duration of less than 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supine position groupThese neonates were placed in supine position, fed every 2 hours in accordance with routine clinical practice, and then returned to supine position. | Behavioural | Supine position group |
| Hourly position change groupInfants 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. | Behavioural | Hourly position change group: |
| 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. | Behavioural | Control Group (2-hour position change) |
Primary outcome
Change in bilirubin level
Time frame: Baseline and 24 hours after phototherapy
bilirubin level change
comfort level questionnaire
Time frame: up to 24 hours
comfort level change
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibel Kücükoglu, professor study director
Selcuk University
Fatma Tas Arslan, professor study director
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine position group and Hourly position change group in people with Bilirubinemia and Newborn Jaundice, run by Selcuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bilirubin level (time frame: Baseline and 24 hours after phototherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.