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Predictors of Rebound Hyperbilirubinemia Study

StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

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  1. Study title expanded, about 2 wordsv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
\## 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.
Trial Details
NCT Number NCT07694635
Lead Sponsor Haseki Training and Research Hospital
Conditions
(from sponsor)		 Neonatal Hyperbilirubinemia, Rebound Hyperbilirubinemia
Related terms Hyperbilirubinemia, Neonatal, Jaundice, Neonatal
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov