Rebound Hyperbilirubinemia Study
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.
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.
Studienübersicht
Status
Detaillierte Beschreibung
## 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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Dilek Kurnaz, M.D
- Telefonnummer: +905556119280
- E-Mail: drdilekkurnaz@gmail.com
Studienorte
-
-
Sultangazi
-
Istanbul, Sultangazi, Türkei (türkiye), 34265
- University of Health Sciences, Haseki Training and Research Hospital
-
Kontakt:
- Dilek Kurnaz, M.D
- Telefonnummer: 05556119280
- E-Mail: drdilekkurnaz@gmail.com
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Clinically Significant Rebound Hyperbilirubinemia Requiring Repeat Phototherapy
Zeitfenster: 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.
|
Within 48 hours after phototherapy discontinuation
|
Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HASEKI-NICU-RHB-2026-01
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Neugeborene Hyperbilirubinämie
-
Sharp HealthCareAbgeschlossenAtelektase Neonatal | Pneumothorax und LuftleckVereinigte Staaten
-
Hacettepe UniversityAbgeschlossenHyperbilirubinämie, neonatal indirektTruthahn
-
Tishreen University HospitalRekrutierungHyperbilirubinämie, neonatal indirektSyrien
-
Fakultas Kedokteran Universitas IndonesiaUnbekanntEnterokolitis, nekrotisierend | Retinopathie der Frühgeburt | Bronchopulmonale Dysplasie | Früh einsetzende Sepsen, Neugeborene | Klein für Säuglinge im Gestationsalter | Periventrikuläre Hämorrhagie Neonatal
-
Sanko UniversityAbgeschlossenFrühgeburt | Atemnotsyndrom | Bronchopulmonale Dysplasie | Komplikation der mechanischen Beatmung | Chronische Lebererkrankung | Hyaline Membrankrankheit | Verfrüht | Sauerstofftoxizität | Neugeborene Ateminsuffizienz | Atelektase Neonatal | Mechanischer Beatmungsdruck hoch | Pneumonie Neugeborene | Lobar KollapsTürkei (türkiye)