Predictors of Rebound Hyperbilirubinemia Study

NCT07694635 | Not Yet Recruiting

• 1 other identifier: HASEKI-NICU-RHB-2026-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Rebound Hyperbilirubinemia; Neonatal Hyperbilirubinemia

Keywords

Rebound Hyperbilirubinemia; Neonatal Jaundice; Phototherapy; Neonate; Repeat Phototherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 48 hours after phototherapy discontinuation

Study Arms (1)

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

Eligibility Criteria

• Age: 2 Hours - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences, Haseki Training and Research Hospital

Istanbul, Sultangazi, 34265, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 41760910 RESULT

Related Links

• \## Prospective study evaluating risk factors and bilirubin rebound after discontinuation of phototherapy in neonates.

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dilek Kurnaz, M.D

  Health Sciences University, Haseki Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Kurnaz, M.D

CONTACT

+905556119280; drdilekkurnaz@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 10, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)