Predictors of Rebound Hyperbilirubinemia Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-28
SponsorHaseki Training and Research Hospital
About this trial
\## 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Major congenital anomalies
Conjugated hyperbilirubinemia
Neonates requiring exchange transfusion before completion of initial phototherapy
Severe perinatal asphyxia
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 1 trial groupGroup A: Neonates Receiving Phototherapy
Trial outcomes
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.
Time frame
Within 48 hours after phototherapy discontinuationSponsors and contacts
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Source ClinicalTrials.gov
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