Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 主要终点
- Change in total serum bilirubin (TSB)
研究概览
简要总结
This is a prospective, randomized, open-label controlled trial comparing fenofibrate (10 mg/kg) and phenobarbitone (3 mg/kg) as adjuncts to conventional phototherapy in neonates with unconjugated hyperbilirubinemia. The study aims to compare their effectiveness in reducing total serum bilirubin. Secondary outcomes include duration of phototherapy, length of hospital stay, and treatment-related adverse effects.
详细描述
Neonatal hyperbilirubinemia is one of the most common conditions requiring medical attention during the neonatal period. Although phototherapy is the standard treatment for uncomplicated indirect hyperbilirubinemia, adjuvant pharmacological therapies may enhance bilirubin clearance and reduce the duration of phototherapy and hospital stay.
Fenofibrate induces hepatic enzymes involved in bilirubin conjugation and excretion, whereas phenobarbitone has traditionally been used to increase bilirubin metabolism through enzyme induction. The comparative effectiveness of these two agents as adjuncts to phototherapy has not been adequately evaluated.
This Phase IV, prospective, randomized, open-label, parallel-group clinical trial aims to compare the efficacy and safety of fenofibrate versus phenobarbitone as adjuncts to conventional phototherapy in neonates with indirect hyperbilirubinemia.
Eligible neonates will be randomly assigned in a 1:1 ratio to receive either fenofibrate plus phototherapy or phenobarbitone plus phototherapy. The primary outcome is the reduction in total serum bilirubin. Secondary outcomes include the duration of phototherapy, length of hospital stay, need for exchange transfusion (if applicable), and the occurrence of adverse events. Participants will be followed until resolution of hyperbilirubinemia and discharge according to the study protocol.
The results of this study are expected to provide evidence regarding the more effective adjunctive therapy for the management of neonatal indirect hyperbilirubinemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 24 Hours 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term neonates aged 24 hours to 14 days with gestational age 37-42 weeks.
- •Birth weight ≥2500 g.
- •Physiological, non-haemolytic indirect hyperbilirubinemia with total serum bilirubin 15-20 mg/dL, requiring phototherapy according to age-specific guidelines.
- •Written informed consent from parents or legal guardian.
排除标准
- •Preterm or low-birth-weight neonates.
- •Jaundice appearing within the first 24 hours of life.
- •ABO or Rh incompatibility, positive direct Coombs test, or any evidence of haemolysis.
- •Neonates with sepsis, birth asphyxia, shock, congenital anomalies, cholestasis, liver or renal disease.
- •Neonates with electrolyte, acid-base, coagulation, or intrauterine infection-related disorders.
- •Previous neonatal use of fenofibrate or phenobarbitone, or maternal phenobarbitone use during pregnancy.
结局指标
主要结局
Change in total serum bilirubin (TSB)
时间窗: Baseline and at 48 hours after initiation of treatment
Change in total serum bilirubin (TSB) level during treatment (serial measurements and comparison between groups).
次要结局
- Duration of phototherapy(From initiation untill discontinuation of phototherapy during index hospitalization(approximately upto 72 hours))
- Duration of Hospital Stay(From hospital admission untill hospital discharge during index hospitalization(approximatley upto 5 days))
- Safety profile (adverse effects) including: Skin rash, Dehydration, Gastrointestinal symptoms, Hepatotoxicity, Renal impairment, Hypoglycemia, Sedation(Baseline and through 48 hours after initiation of treatment)
研究者
Rubab Fatima
Sheikh Zayed Medical College, Rahim yar Khan.
Sheikh Zayed Medical College