Newborn; VitalityNCT06324799
The Effect of Position Change Frequency on Hyperbilirubinemia
A study testing phototherapy treatment in people with Newborn; Vitality and Hyperbilirubinemia, Neonatal, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
In our study, the effect of the frequency of position changes on hyperbilirubinemia in babies hospitalized in the Neonatal Intensive Care Unit and receiving phototherapy treatment will be investigated. Read more about this study
- Who is it for?
- Ages 1 day to 15 days
- Conditions the study is for
- Newborn; Vitality, Hyperbilirubinemia, Neonatal
- What is being tested?
- phototherapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2024to 24 Mar 2025
- 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 1 day to 15 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born after 37 weeks of gestation, receiving treatment at Mersin City Training and Research Hospital Neonatal Intensive Care Service,
- There is an indication for phototherapy treatment in the phototherapy nomogram, where the total serum bilirubin value is evaluated according to the patient's postnatal day and risk factors,
- Postnatal 1-15. on the day,
- Patients whose families approve the informed consent form.
Who cannot join
- Older than the 15th postnatal day,
- There is an indication for exchange transfusion in the blood exchange curve, where the total serum bilirubin value is evaluated according to the patient's day and risk factors,
- Having a major anomaly or disease detected antenatally,
- Patients with comorbid diseases such as perinatal asphyxia, bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, congenital heart disease and similar diseases will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Position Change Frequency on Hyperbilirubinemia in Term Infants Receiving Phototherapy
In our study, the effect of the frequency of position changes on hyperbilirubinemia in babies hospitalized in the Neonatal Intensive Care Unit and receiving phototherapy treatment will be investigated.
This study was planned as a single-center randomized controlled clinical trial to examine the effect of the frequency of position changes on the time it takes for hyperbilirubinemia to subside in babies receiving phototherapy treatment in the Neonatal Intensive Care Unit of Mersin City Training and Research Hospital.
Read more
Babies included in the study will be randomly divided into two groups by randomization method. While the babies in the study group will be subjected to position changes (supine, prone, lateral) every 2 hours, the same procedure will be applied to the control group every 6 hours. All newborns included in the study were treated with the Unitest (Blue angel) LED Phototherapy device, which is used as standard in the neonatal intensive care unit, at a distance of 25-40 cm, at a wavelength of 425-475 nm, at 45 watts, at 50/60 Hz. Phototherapy will be applied unidirectionally. During phototherapy, only the perineal area of the babies will be covered with a reduced diaper, and their eyes will be covered with a three-layer, cotton, black eye patch that transmits 99.5% of ultraviolet rays. During phototherapy sessions, the total serum bilirubin level of the patient is checked; Phototherapy will be continued until it falls below the threshold value in the Bhutani nomogram, which is evaluated according to postnatal days and risk factors. The descriptive characteristics of the babies included in the study and their total bilirubin and hematocrit values before the start of phototherapy will be recorded on the form prepared by the researchers. After phototherapy begins, position changes will be made every two hours for babies in the experimental group and every six hours for babies in the control group until the total serum bilirubin value falls below the phototherapy threshold value in the Bhutani nomogram.
Bilirubin levels will be measured and recorded by venous measurement at the sixth hour and the 24th hour, and this process will be continued regularly until the bilirubin value decreases to the normal range. This practice is performed routinely in the clinic and will not be considered specific to the study.
Read the detailed description
This study was planned as a single-center randomized controlled clinical trial to examine the effect of the frequency of position changes on the time it takes for hyperbilirubinemia to subside in babies receiving phototherapy treatment in the Neonatal Intensive Care Unit of Mersin City Training and Research Hospital.
Randomization and Masking: Randomization will be achieved by randomly and equally distributing patients who meet the sample selection criteria to 2 groups (group 1 study group and group 2 control group) through a computer program. Randomization will also be stratified according to the feeding style of the babies, as breast-fed babies may affect the duration of phototherapy. Stratified randomization will be performed according to whether the babies are fed with breast milk or formula.
(http://www1.assumption.edu/users/avadum/applets/RandAssign/GroupGen.html).
Babies included in the study will be randomly divided into two groups by randomization method. While the babies in the study group will be subjected to position changes (supine, prone, lateral) every 2 hours, the same procedure will be applied to the control group every 6 hours. All newborns included in the study were treated with the Unitest (Blue angel) LED Phototherapy device, which is used as standard in the neonatal intensive care unit, at a distance of 25-40 cm, at a wavelength of 425-475 nm, at 45 watts, at 50/60 Hz. Phototherapy will be applied unidirectionally. During phototherapy, only the perineal area of the babies will be covered with a reduced diaper, and their eyes will be covered with a three-layer, cotton, black eye patch that transmits 99.5% of ultraviolet rays. During phototherapy sessions, the total serum bilirubin level of the patient is checked; Phototherapy will be continued until it falls below the threshold value in the Bhutani nomogram, which is evaluated according to postnatal days and risk factors. The descriptive characteristics of the babies included in the study and their total bilirubin and hematocrit values before the start of phototherapy will be recorded on the form prepared by the researchers. After phototherapy begins, position changes will be made every two hours for babies in the experimental group and every six hours for babies in the control group until the total serum bilirubin value falls below the phototherapy threshold value in the Bhutani nomogram.
Bilirubin levels will be measured and recorded by venous measurement at the sixth hour and the 24th hour, and this process will be continued regularly until the bilirubin value decreases to the normal range. This practice is performed routinely in the clinic and will not be considered specific to the study.
In both groups, babies will start phototherapy in the prone position, and the patients will continue to be fed 8 times a day, at 3-hour intervals, as the routine of the neonatal intensive care unit. Babies will be fed by turning off phototherapy for a maximum of 15 minutes, thus minimizing phototherapy interruption. Care will be taken not to exceed this period for babies who are breastfed by their mothers.
Data Collection Tools
Baby Identification Information Form: The form includes descriptive characteristics of the babies included in the study; It includes questions about their gender, mode of birth, birth weight, gestational age, Apgar score, weight, bilirubin level and hematocrit level.
Bhutani Nomogram: Each bilirubin value must be interpreted according to the "bilirubin nomogram" prepared according to the baby's age in hours. The use of the nomogram according to postnatal age allows monitoring the course of repeated bilirubin values and predicting the baby who will later develop hyperbilirubinemia. This scale, known as the "Bhutani nomogram" and has been widely used since 1999, will be used in our study.
Evaluation of Data The analysis of the data obtained from the research will be carried out in the SPSS 22.0 statistical package program. The statistical significance level was determined as 0.05. Kolmogrow-Smirnov will be used in the normality analysis of dependent variables. Chi-square and comparison of means tests will be used to determine the similarity of the groups. In comparing between and within groups averages, appropriate parametric or non-parametric tests will be used, depending on whether the distribution is normal. In addition, at the end of the research, whether the study has been conducted with a sufficient sample size will be tested with post-hoc power analysis.
- Conditions
- Newborn; Vitality, Hyperbilirubinemia, Neonatal
- Being tested
- phototherapy treatment
- Keywords
- Hyperbilirubinemia, newborn, Phototherapy
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phototherapy treatmentOther
The newborns in the study group will be subjected to position changes (supine, prone, lateral) every 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Position group every 2 hours | Experimental | Newborns in the study group will change position (supine, prone, lateral) every 2 hours. Receives: Other: phototherapy treatment |
| Control group | No intervention | Newborns in the control group will change position (supine, prone, lateral) every 6 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bhutani Nomogram
Each bilirubin value must be interpreted according to the "bilirubin nomogram" prepared according to the baby's age in hours. The use of the nomogram according to postnatal age allows monitoring the course of repeated bilirubin values and predicting the baby who will later develop hyperbilirubinemia. This scale, known as the "Bhutani nomogram" and has been widely used since 1999, will be used in our study.
Measured: 1 day
Secondary outcomes (2)
bilirubin level
bilirubin level in blood
Measured: 1 day
hematocrit levels
hematocrit value in blood
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start14 Mar 2024
- Primary completion14 Sep 2024
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Newborn; VitalityStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atiye Karakul, Tarsus University
- Investigators
- Çağla Tarcan, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324799
- Sponsor's protocol ID
- 2023/51
- Status last verified
- Apr 2025
- First submitted
- 14 Mar 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Academy of Pediatrics, Clinical Practice Guideline, Subcommittee on Hyperbilirubinemia. Management
Karen Marcdante & Robert M. Kliegman & Abigail M. Schuh. 2023 Nelson Essentials of Pediatrics 9th edition. 2022. p. 953-60.
Ovalı F., Dağoğlu T. Neonatoloji. İndirekt Hiperbilirubinemi. 3. Baskı İstanbul: Nobel Tıp Kitabevleri Tic. Ltd. Şti.; 2018. p. 959-84.
Bhethanabhotla S, Thukral A, Sankar MJ, Agarwal R, Paul VK, Deorari AK. Effect of position of infant during phototherapy in management of hyperbilirubinemia in late preterm and term neonates: a randomized controlled trial. J Perinatol. 2013 Oct;33(10):795-9. doi: 10.1038/jp.2013.54. Epub 2013 Jun 6.
PubMed 23743672Thukral A, Deorari A, Chawla D. Periodic change of body position under phototherapy in term and preterm neonates with hyperbilirubinaemia. Cochrane Database Syst Rev. 2022 Mar 2;3(3):CD011997. doi: 10.1002/14651858.CD011997.pub2.
PubMed 35235686Shinwell ES, Sciaky Y, Karplus M. Effect of position changing on bilirubin levels during phototherapy. J Perinatol. 2002 Apr-May;22(3):226-9. doi: 10.1038/sj.jp.7210678.
PubMed 11948386Akkuzu, A. (2021). Hiperbilirubinemi tanısı ile yenidoğan yoğun bakım ünitesinde yatan bebeklerin beslenme şekilleri ile hastanede kalış süreleri arasındaki ilişki (Master's thesis, İstanbul Medipol Üniversitesi Sağlık Bilimleri Enstitüsü).
Donneborg ML, Knudsen KB, Ebbesen F. Effect of infants' position on serum bilirubin level during conventional phototherapy. Acta Paediatr. 2010 Aug;99(8):1131-4. doi: 10.1111/j.1651-2227.2010.01885.x. Epub 2010 Jun 2.
PubMed 20528799Lee Wan Fei S, Abdullah KL. Effect of turning vs. supine position under phototherapy on neonates with hyperbilirubinemia: a systematic review. J Clin Nurs. 2015 Mar;24(5-6):672-82. doi: 10.1111/jocn.12712. Epub 2014 Oct 16.
PubMed 25319831Chen CM, Liu SH, Lai CC, Hwang CC, Hsu HH. Changing position does not improve the efficacy of conventional phototherapy. Acta Paediatr Taiwan. 2002 Sep-Oct;43(5):255-8.
PubMed 12607480
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Position Change Frequency on Hyperbilirubinemia in Term Infants Receiving Phototherapy
- ClinicalTrials.gov ID
- NCT06324799
- Acronym / sponsor ID
- 2023/51
- Conditions
- Newborn; Vitality, Hyperbilirubinemia, Neonatal
- Keywords
- Hyperbilirubinemia, newborn, Phototherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 14 Sep 2024 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 22 Mar 2024 (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.
In our study, the effect of the frequency of position changes on hyperbilirubinemia in babies hospitalized in the Neonatal Intensive Care Unit and receiving phototherapy treatment will be investigated.
This study was planned as a single-center randomized controlled clinical trial to examine the effect of the frequency of position changes on the time it takes for hyperbilirubinemia to subside in babies receiving phototherapy treatment in the Neonatal Intensive Care Unit of Mersin City Training and Research Hospital.
Babies included in the study will be randomly divided into two groups by randomization method. While the babies in the study group will be subjected to position changes (supine, prone, lateral) every 2 hours, the same procedure will be applied to the control group every 6 hours. All newborns included in the study were treated with the Unitest (Blue angel) LED Phototherapy device, which is used as standard in the neonatal intensive care unit, at a distance of 25-40 cm, at a wavelength of 425-475 nm, at 45 watts, at 50/60 Hz. Phototherapy will be applied unidirectionally. During phototherapy, only the perineal area of the babies will be covered with a reduced diaper, and their eyes will be covered with a three-layer, cotton, black eye patch that transmits 99.5% of ultraviolet rays. During phototherapy sessions, the total serum bilirubin level of the patient is checked; Phototherapy will be continued until it falls below the threshold value in the Bhutani nomogram, which is evaluated according to postnatal days and risk factors. The descriptive characteristics of the babies included in the study and their total bilirubin and hematocrit values before the start of phototherapy will be recorded on the form prepared by the researchers. After phototherapy begins, position changes will be made every two hours for babies in the experimental group and every six hours for babies in the control group until the total serum bilirubin value falls below the phototherapy threshold value in the Bhutani nomogram.
Bilirubin levels will be measured and recorded by venous measurement at the sixth hour and the 24th hour, and this process will be continued regularly until the bilirubin value decreases to the normal range. This practice is performed routinely in the clinic and will not be considered specific to the study.
Detailed description
This study was planned as a single-center randomized controlled clinical trial to examine the effect of the frequency of position changes on the time it takes for hyperbilirubinemia to subside in babies receiving phototherapy treatment in the Neonatal Intensive Care Unit of Mersin City Training and Research Hospital.
Randomization and Masking: Randomization will be achieved by randomly and equally distributing patients who meet the sample selection criteria to 2 groups (group 1 study group and group 2 control group) through a computer program. Randomization will also be stratified according to the feeding style of the babies, as breast-fed babies may affect the duration of phototherapy. Stratified randomization will be performed according to whether the babies are fed with breast milk or formula.
(http://www1.assumption.edu/users/avadum/applets/RandAssign/GroupGen.html).
Babies included in the study will be randomly divided into two groups by randomization method. While the babies in the study group will be subjected to position changes (supine, prone, lateral) every 2 hours, the same procedure will be applied to the control group every 6 hours. All newborns included in the study were treated with the Unitest (Blue angel) LED Phototherapy device, which is used as standard in the neonatal intensive care unit, at a distance of 25-40 cm, at a wavelength of 425-475 nm, at 45 watts, at 50/60 Hz. Phototherapy will be applied unidirectionally. During phototherapy, only the perineal area of the babies will be covered with a reduced diaper, and their eyes will be covered with a three-layer, cotton, black eye patch that transmits 99.5% of ultraviolet rays. During phototherapy sessions, the total serum bilirubin level of the patient is checked; Phototherapy will be continued until it falls below the threshold value in the Bhutani nomogram, which is evaluated according to postnatal days and risk factors. The descriptive characteristics of the babies included in the study and their total bilirubin and hematocrit values before the start of phototherapy will be recorded on the form prepared by the researchers. After phototherapy begins, position changes will be made every two hours for babies in the experimental group and every six hours for babies in the control group until the total serum bilirubin value falls below the phototherapy threshold value in the Bhutani nomogram.
Bilirubin levels will be measured and recorded by venous measurement at the sixth hour and the 24th hour, and this process will be continued regularly until the bilirubin value decreases to the normal range. This practice is performed routinely in the clinic and will not be considered specific to the study.
In both groups, babies will start phototherapy in the prone position, and the patients will continue to be fed 8 times a day, at 3-hour intervals, as the routine of the neonatal intensive care unit. Babies will be fed by turning off phototherapy for a maximum of 15 minutes, thus minimizing phototherapy interruption. Care will be taken not to exceed this period for babies who are breastfed by their mothers.
Data Collection Tools
Baby Identification Information Form: The form includes descriptive characteristics of the babies included in the study; It includes questions about their gender, mode of birth, birth weight, gestational age, Apgar score, weight, bilirubin level and hematocrit level.
Bhutani Nomogram: Each bilirubin value must be interpreted according to the "bilirubin nomogram" prepared according to the baby's age in hours. The use of the nomogram according to postnatal age allows monitoring the course of repeated bilirubin values and predicting the baby who will later develop hyperbilirubinemia. This scale, known as the "Bhutani nomogram" and has been widely used since 1999, will be used in our study.
Evaluation of Data The analysis of the data obtained from the research will be carried out in the SPSS 22.0 statistical package program. The statistical significance level was determined as 0.05. Kolmogrow-Smirnov will be used in the normality analysis of dependent variables. Chi-square and comparison of means tests will be used to determine the similarity of the groups. In comparing between and within groups averages, appropriate parametric or non-parametric tests will be used, depending on whether the distribution is normal. In addition, at the end of the research, whether the study has been conducted with a sufficient sample size will be tested with post-hoc power analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Position group every 2 hours | Experimental | Other: phototherapy treatmentNewborns in the study group will change position (supine, prone, lateral) every 2 hours. |
| Control group | No intervention | –Newborns in the control group will change position (supine, prone, lateral) every 6 hours. |
Who may qualify
- Ages
- 1 day to 15 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Born after 37 weeks of gestation, receiving treatment at Mersin City Training and Research Hospital Neonatal Intensive Care Service,
- There is an indication for phototherapy treatment in the phototherapy nomogram, where the total serum bilirubin value is evaluated according to the patient's postnatal day and risk factors,
- Postnatal 1-15. on the day,
- Patients whose families approve the informed consent form.
Key exclusion criteria (4 listed)
- Older than the 15th postnatal day,
- There is an indication for exchange transfusion in the blood exchange curve, where the total serum bilirubin value is evaluated according to the patient's day and risk factors,
- Having a major anomaly or disease detected antenatally,
- Patients with comorbid diseases such as perinatal asphyxia, bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, congenital heart disease and similar diseases will not be included in the study.
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 |
|---|---|---|
| phototherapy treatmentThe newborns in the study group will be subjected to position changes (supine, prone, lateral) every 2 hours | Other | Position group every 2 hours |
Primary outcome
Bhutani Nomogram
Time frame: 1 day
Each bilirubin value must be interpreted according to the "bilirubin nomogram" prepared according to the baby's age in hours. The use of the nomogram according to postnatal age allows monitoring the course of repeated bilirubin values and predicting the baby who will later develop hyperbilirubinemia. This scale, known as the "Bhutani nomogram" and has been widely used since 1999, will be used in our study.
2 secondary outcomes
bilirubin level
Time frame: 1 day
hematocrit levels
Time frame: 1 day
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 15 Apr 2025.
- Results publicationAmerican Academy of Pediatrics, Clinical Practice Guideline, Subcommittee on Hyperbilirubinemia. Management
- Results publicationKaren Marcdante & Robert M. Kliegman & Abigail M. Schuh. 2023 Nelson Essentials of Pediatrics 9th edition. 2022. p. 953-60.
- Results publicationOvalı F., Dağoğlu T. Neonatoloji. İndirekt Hiperbilirubinemi. 3. Baskı İstanbul: Nobel Tıp Kitabevleri Tic. Ltd. Şti.; 2018. p. 959-84.
- Results publication: PubMed 23743672Bhethanabhotla S, Thukral A, Sankar MJ, Agarwal R, Paul VK, Deorari AK. Effect of position of infant during phototherapy in management of hyperbilirubinemia in late preterm and term neonates: a randomized controlled trial. J Perinatol. 2013 Oct;33(10):795-9. doi: 10.1038/jp.2013.54. Epub 2013 Jun 6.
- Results publication: PubMed 35235686Thukral A, Deorari A, Chawla D. Periodic change of body position under phototherapy in term and preterm neonates with hyperbilirubinaemia. Cochrane Database Syst Rev. 2022 Mar 2;3(3):CD011997. doi: 10.1002/14651858.CD011997.pub2.
- Results publication: PubMed 11948386Shinwell ES, Sciaky Y, Karplus M. Effect of position changing on bilirubin levels during phototherapy. J Perinatol. 2002 Apr-May;22(3):226-9. doi: 10.1038/sj.jp.7210678.
- Results publicationAkkuzu, A. (2021). Hiperbilirubinemi tanısı ile yenidoğan yoğun bakım ünitesinde yatan bebeklerin beslenme şekilleri ile hastanede kalış süreleri arasındaki ilişki (Master's thesis, İstanbul Medipol Üniversitesi Sağlık Bilimleri Enstitüsü).
- Results publication: PubMed 20528799Donneborg ML, Knudsen KB, Ebbesen F. Effect of infants' position on serum bilirubin level during conventional phototherapy. Acta Paediatr. 2010 Aug;99(8):1131-4. doi: 10.1111/j.1651-2227.2010.01885.x. Epub 2010 Jun 2.
- Results publication: PubMed 25319831Lee Wan Fei S, Abdullah KL. Effect of turning vs. supine position under phototherapy on neonates with hyperbilirubinemia: a systematic review. J Clin Nurs. 2015 Mar;24(5-6):672-82. doi: 10.1111/jocn.12712. Epub 2014 Oct 16.
- Results publication: PubMed 12607480Chen CM, Liu SH, Lai CC, Hwang CC, Hsu HH. Changing position does not improve the efficacy of conventional phototherapy. Acta Paediatr Taiwan. 2002 Sep-Oct;43(5):255-8.
- 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.
Çağla Tarcan principal investigator
Mersin 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 phototherapy treatment in people with Newborn; Vitality and Hyperbilirubinemia, Neonatal, run by Tarsus 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 4 inclusion and 4 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 15 Apr 2025. 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?
Bhutani Nomogram (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06324799, which also lists 10 linked publications.
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 15 Apr 2025.