Neonatal HyperbilirubinemiaNCT07694635
Predictors of Rebound Hyperbilirubinemia Study
An observational study of Neonatal Hyperbilirubinemia and Rebound Hyperbilirubinemia, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
## Brief Summary Neonatal hyperbilirubinemia is one of the most common causes of neonatal hospitalization and phototherapy treatment. Although phototherapy is highly effective, rebound hyperbilirubinemia following discontinuation of phototherapy may occur in some infants and may require repeat treatment. Read more about this study
- Who is it for?
- Ages 2 hours to 28 days
- Conditions the study is for
- Neonatal Hyperbilirubinemia, Rebound Hyperbilirubinemia
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to Nov 2026
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 2 hours to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of neonates admitted to the NICU for neonatal hyperbilirubinemia and treated with phototherapy according to institutional protocols and current guideline-based phototherapy thresholds. Both standard and intensive phototherapy modalities may be used based on bilirubin levels, gestational age, and neurotoxicity risk factors. Eligible neonates will be prospectively followed after discontinuation of phototherapy for evaluation of rebound hyperbilirubinemia and repeat phototherapy requirement. Clinical, laboratory, hemolytic, feeding-related, and phototherapy-related variables will be recorded and analyzed to identify predictors of clinically significant rebound hyperbilirubinemia.
Who may be able to join
- Neonates admitted to the NICU with neonatal hyperbilirubinemia
- Gestational age ≥35 weeks
- Requirement for phototherapy according to institutional protocol and current guideline-based phototherapy thresholds
- Receipt of standard and/or intensive phototherapy
- Availability of bilirubin measurements before, during, and after phototherapy
- Availability of rebound bilirubin measurement within 48 hours after phototherapy discontinuation
- Written informed consent obtained from parents or legal guardians, if required by the ethics committee
Who cannot join
- Major congenital anomalies
- Conjugated hyperbilirubinemia
- Neonates requiring exchange transfusion before completion of initial phototherapy
- Severe perinatal asphyxia
- Proven or suspected inborn errors of metabolism affecting bilirubin metabolism
- Significant congenital liver disease
Show all 10Show fewer
- Neonates transferred to another center before completion of rebound bilirubin follow-up
- Missing or incomplete clinical or laboratory data
- Absence of rebound bilirubin measurement within 48 hours after phototherapy discontinuation
- Parents or legal guardians declining participation, if consent is required
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences, Haseki Training and Research Hospital
Istanbul, Sultangazi, 34265
Dilek Kurnaz, M.D, 05556119280, drdilekkurnaz@gmail.com
About this study
Official title: Predictors of Rebound Hyperbilirubinemia After Phototherapy in Neonates
## Brief Summary
Neonatal hyperbilirubinemia is one of the most common causes of neonatal hospitalization and phototherapy treatment. Although phototherapy is highly effective, rebound hyperbilirubinemia following discontinuation of phototherapy may occur in some infants and may require repeat treatment. Early identification of neonates at risk for clinically significant rebound hyperbilirubinemia could help optimize discharge timing and reduce unnecessary hospital stay and repeat bilirubin testing.
Read more
This prospective observational study aims to evaluate the predictors of rebound hyperbilirubinemia after phototherapy discontinuation in neonates admitted to the NICU. Particular focus will be placed on the role of delta total serum bilirubin (ΔTSB), defined as the difference between the phototherapy threshold and the measured bilirubin level at the time of phototherapy discontinuation. Clinical, demographic, laboratory, hemolytic, feeding-related, and phototherapy-related variables will also be analyzed.
The primary outcome will be clinically significant rebound hyperbilirubinemia requiring repeat phototherapy within 24-48 hours after discontinuation of the initial phototherapy treatment. Secondary outcomes include rebound bilirubin levels, duration of hospitalization, and factors associated with repeat phototherapy.
Read the detailed description
## Detailed Description
Neonatal hyperbilirubinemia remains one of the leading causes of neonatal hospitalization worldwide. Phototherapy is the standard treatment for significant unconjugated hyperbilirubinemia and is highly effective in reducing serum bilirubin levels. However, a subset of neonates may develop rebound hyperbilirubinemia after discontinuation of phototherapy, occasionally requiring repeat phototherapy and prolonged hospitalization.
Current evidence regarding predictors of rebound hyperbilirubinemia remains limited, particularly in prospective NICU-based cohorts. Identification of infants at increased risk for clinically significant rebound hyperbilirubinemia may improve individualized monitoring strategies, optimize timing of discharge, and reduce unnecessary bilirubin measurements and hospital stay.
This prospective observational study will include neonates admitted to the NICU and treated with phototherapy for hyperbilirubinemia. Clinical and laboratory parameters associated with rebound hyperbilirubinemia will be evaluated. Special emphasis will be placed on delta total serum bilirubin (ΔTSB), defined as the difference between the phototherapy threshold recommended by current guidelines and the measured total serum bilirubin level at the time of phototherapy discontinuation.
Additional variables including gestational age, postnatal age at phototherapy initiation, feeding type, hemolytic risk factors, bilirubin kinetics, and phototherapy characteristics will also be analyzed. Rebound bilirubin measurements will be obtained within 24-48 hours after discontinuation of phototherapy according to unit protocol.
The primary objective is to determine predictors of clinically significant rebound hyperbilirubinemia requiring repeat phototherapy. Secondary objectives include evaluation of bilirubin rebound levels, hospitalization duration, and the association between phototherapy characteristics and rebound risk.
- Keywords
- Rebound Hyperbilirubinemia, Neonatal Jaundice, Phototherapy, Neonate, Repeat Phototherapy
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neonates Receiving Phototherapy | This cohort includes neonates admitted to the NICU and treated with phototherapy for neonatal hyperbilirubinemia according to current institutional protocols and guideline-based phototherapy thresholds. Both standard and intensive phototherapy modalities may be used depending on bilirubin levels, gestational age, and neurotoxicity risk factors. Phototherapy is administered using Astek phototherapy devices and/or tunnel phototherapy systems, either as single-device or double-device therapy. Irradiance intensity may be adjusted according to clinical severity. Phototherapy is applied continuously except during feeding and routine care intervals. Serum bilirubin levels are monitored during and after phototherapy according to unit protocol. Rebound bilirubin measurements are routinely obtained after discontinuation of phototherapy, and additional measurements are performed in neonates considered at increased risk for rebound hyperbilirubinemia. Clinical, labo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically Significant Rebound Hyperbilirubinemia Requiring Repeat Phototherapy
Clinically significant rebound hyperbilirubinemia is defined as an increase in total serum bilirubin after discontinuation of initial phototherapy that reaches the guideline-based phototherapy threshold and requires initiation of repeat phototherapy.
Measured: Within 48 hours after phototherapy discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start15 Jun 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal HyperbilirubinemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berker Okay, Haseki Training and Research Hospital
- Investigators
- Dilek Kurnaz, M.D, Principal investigator, Health Sciences University, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694635
- Sponsor's protocol ID
- HASEKI-NICU-RHB-2026-01
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared because the study involves sensitive neonatal clinical data obtained from a single-center NICU cohort. Data sharing may be restricted by institutional policies and ethical considerations regarding patient confidentiality and privacy. Aggregated and anonymized study results will be presented in scientific publications and presentations.
Publications
Donneborg ML, Thorsteinsson K, Bruun NH, Ebbesen F. Short-time intensive phototherapy of hyperbilirubinemic neonates: efficacy, bilirubin rebound and risk factors for rebound. Pediatr Res. 2026 Feb 28. doi: 10.1038/s41390-026-04870-3. Online ahead of print.
PubMed 41760910
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Rebound Hyperbilirubinemia After Phototherapy in Neonates
- ClinicalTrials.gov ID
- NCT07694635
- Acronym / sponsor ID
- HASEKI-NICU-RHB-2026-01
- Keywords
- Rebound Hyperbilirubinemia, Neonatal Jaundice, Phototherapy, Neonate, Repeat Phototherapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 Jul 2026 (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.
## Brief Summary
Neonatal hyperbilirubinemia is one of the most common causes of neonatal hospitalization and phototherapy treatment. Although phototherapy is highly effective, rebound hyperbilirubinemia following discontinuation of phototherapy may occur in some infants and may require repeat treatment. Early identification of neonates at risk for clinically significant rebound hyperbilirubinemia could help optimize discharge timing and reduce unnecessary hospital stay and repeat bilirubin testing.
This prospective observational study aims to evaluate the predictors of rebound hyperbilirubinemia after phototherapy discontinuation in neonates admitted to the NICU. Particular focus will be placed on the role of delta total serum bilirubin (ΔTSB), defined as the difference between the phototherapy threshold and the measured bilirubin level at the time of phototherapy discontinuation. Clinical, demographic, laboratory, hemolytic, feeding-related, and phototherapy-related variables will also be analyzed.
The primary outcome will be clinically significant rebound hyperbilirubinemia requiring repeat phototherapy within 24-48 hours after discontinuation of the initial phototherapy treatment. Secondary outcomes include rebound bilirubin levels, duration of hospitalization, and factors associated with repeat phototherapy.
Detailed description
## Detailed Description
Neonatal hyperbilirubinemia remains one of the leading causes of neonatal hospitalization worldwide. Phototherapy is the standard treatment for significant unconjugated hyperbilirubinemia and is highly effective in reducing serum bilirubin levels. However, a subset of neonates may develop rebound hyperbilirubinemia after discontinuation of phototherapy, occasionally requiring repeat phototherapy and prolonged hospitalization.
Current evidence regarding predictors of rebound hyperbilirubinemia remains limited, particularly in prospective NICU-based cohorts. Identification of infants at increased risk for clinically significant rebound hyperbilirubinemia may improve individualized monitoring strategies, optimize timing of discharge, and reduce unnecessary bilirubin measurements and hospital stay.
This prospective observational study will include neonates admitted to the NICU and treated with phototherapy for hyperbilirubinemia. Clinical and laboratory parameters associated with rebound hyperbilirubinemia will be evaluated. Special emphasis will be placed on delta total serum bilirubin (ΔTSB), defined as the difference between the phototherapy threshold recommended by current guidelines and the measured total serum bilirubin level at the time of phototherapy discontinuation.
Additional variables including gestational age, postnatal age at phototherapy initiation, feeding type, hemolytic risk factors, bilirubin kinetics, and phototherapy characteristics will also be analyzed. Rebound bilirubin measurements will be obtained within 24-48 hours after discontinuation of phototherapy according to unit protocol.
The primary objective is to determine predictors of clinically significant rebound hyperbilirubinemia requiring repeat phototherapy. Secondary objectives include evaluation of bilirubin rebound levels, hospitalization duration, and the association between phototherapy characteristics and rebound risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates Receiving Phototherapy | – | –This cohort includes neonates admitted to the NICU and treated with phototherapy for neonatal hyperbilirubinemia according to current institutional protocols and guideline-based phototherapy thresholds. Both standard and intensive phototherapy modalities may be used depending on bilirubin levels, gestational age, and neurotoxicity risk factors. Phototherapy is administered using Astek phototherapy devices and/or tunnel phototherapy systems, either as single-device or double-device therapy. Irradiance intensity may be adjusted according to clinical severity. Phototherapy is applied continuously except during feeding and routine care intervals. Serum bilirubin levels are monitored during and after phototherapy according to unit protocol. Rebound bilirubin measurements are routinely obtained after discontinuation of phototherapy, and additional measurements are performed in neonates considered at increased risk for rebound hyperbilirubinemia. Clinical, labo |
Who may qualify
- Ages
- 2 hours to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of neonates admitted to the NICU for neonatal hyperbilirubinemia and treated with phototherapy according to institutional protocols and current guideline-based phototherapy thresholds. Both standard and intensive phototherapy modalities may be used based on bilirubin levels, gestational age, and neurotoxicity risk factors. Eligible neonates will be prospectively followed after discontinuation of phototherapy for evaluation of rebound hyperbilirubinemia and repeat phototherapy requirement. Clinical, laboratory, hemolytic, feeding-related, and phototherapy-related variables will be recorded and analyzed to identify predictors of clinically significant rebound hyperbilirubinemia.
Key inclusion criteria (7 listed)
- Neonates admitted to the NICU with neonatal hyperbilirubinemia
- Gestational age ≥35 weeks
- Requirement for phototherapy according to institutional protocol and current guideline-based phototherapy thresholds
- Receipt of standard and/or intensive phototherapy
- Availability of bilirubin measurements before, during, and after phototherapy
Key exclusion criteria (10 listed)
- Major congenital anomalies
- Conjugated hyperbilirubinemia
- Neonates requiring exchange transfusion before completion of initial phototherapy
- Severe perinatal asphyxia
- Proven or suspected inborn errors of metabolism affecting bilirubin metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinically Significant Rebound Hyperbilirubinemia Requiring Repeat Phototherapy
Time frame: Within 48 hours after phototherapy discontinuation
Clinically significant rebound hyperbilirubinemia is defined as an increase in total serum bilirubin after discontinuation of initial phototherapy that reaches the guideline-based phototherapy threshold and requires initiation of repeat phototherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Results publication: PubMed 41760910Donneborg ML, Thorsteinsson K, Bruun NH, Ebbesen F. Short-time intensive phototherapy of hyperbilirubinemic neonates: efficacy, bilirubin rebound and risk factors for rebound. Pediatr Res. 2026 Feb 28. doi: 10.1038/s41390-026-04870-3. Online ahead of print.
- \## Prospective study evaluating risk factors and bilirubin rebound after discontinuation of phototherapy in neonates.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared because the study involves sensitive neonatal clinical data obtained from a single-center NICU cohort. Data sharing may be restricted by institutional policies and ethical considerations regarding patient confidentiality and privacy. Aggregated and anonymized study results will be presented in scientific publications and presentations.
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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.
Dilek Kurnaz, M.D principal investigator
Health Sciences University, Haseki Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Hyperbilirubinemia and Rebound Hyperbilirubinemia, run by Haseki Training and Research Hospital 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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 13 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilek Kurnaz, M.D (+905556119280, drdilekkurnaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically Significant Rebound Hyperbilirubinemia Requiring Repeat Phototherapy (time frame: Within 48 hours after phototherapy discontinuation). 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 NCT07694635, which also lists 1 linked publication.
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 13 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.