Predictors of Rebound Hyperbilirubinemia After Phototherapy in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Clinically Significant Rebound Hyperbilirubinemia Requiring Repeat Phototherapy
研究概览
简要总结
## 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.
详细描述
## 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Hours 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
结局指标
主要结局
Clinically Significant Rebound Hyperbilirubinemia Requiring Repeat Phototherapy
时间窗: 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.
次要结局
未报告次要终点
研究者
Berker Okay
M.D
Haseki Training and Research Hospital