A Prospective Open-label Randomized Controlled Trial , Evaluating the Efficacy of Ursodeoxycholic Acid (UDCA) as an Adjuvant to Phototherapy in Neonates With Indirect Hyperbilirubinemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Reduction of total serum bilirubin to below phototherapy threshold
研究概览
简要总结
This is a prospective, open-label, randomized controlled trial conducted at Lattakia University Hospital (Tishreen University), aiming to evaluate the efficacy of Ursodeoxycholic Acid (UDCA) as an adjuvant to triple phototherapy in the management of indirect hyperbilirubinemia in neonates ≥34 weeks of gestation.
Eligible neonates will be randomly assigned to one of two groups:
Group A: continuous triple phototherapy only
Group B: UDCA (10 mg/kg/day in two oral doses) in addition to triple continuous phototherapy.
Stratified randomization will be applied according to etiology (hemolytic, non-hemolytic, G6PD deficiency). The primary outcome is the rate and time of decline in total and indirect serum bilirubin to below phototherapy thresholds, monitored every 12 hours until discharge.
This trial seeks to determine whether UDCA may reduce phototherapy duration or enhance bilirubin clearance in a safe and effective manner.
Although this is an open-label trial for care providers and participants , the statstican conducting data analysis will be blinded to group allocation to reduce assessment bias.
详细描述
This is a prospective, open-label, randomized controlled clinical trial designed to assess the efficacy of ursodeoxycholic acid (UDCA) as an adjuvant to continuous triple phototherapy in neonates with indirect hyperbilirubinemia.
The study includes neonates ≥34 weeks gestational age and appropriate for gestational age (AGA), who meet the American Academy of Pediatrics (AAP) criteria for starting phototherapy.
Participants will be randomized 1:1 into two parallel arms:
Group A (Control): Continuous triple phototherapy
Group B (Intervention): Continuous triple phototherapy + oral UDCA at a dose of 10 mg/kg/day divided into two doses, using locally available Ursorasha (Rasha Pharma, license #1991/1192).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates with gestational age ≥ 34 weeks
- •Appropriate for Gestational Age (AGA) infants
- •Presence of indirect hyperbilirubinemia that meets the threshold for phototherapy.
排除标准
- •Gestational age < 34 weeks
- •Small or Large for Gestational Age
- •Direct (conjugated) hyperbilirubinemia > 20% of total bilirubin
- •Suspected or confirmed sepsis
- •Neonates of diabetic mothers
- •Presence of congenital or acquired liver disease
- •Receiving Total Parenteral Nutrition (TPN)
研究组 & 干预措施
Group B - phototherapy + UDCA
Phototherapy + UDCA
干预措施: ursodeoxycholic acid (UDCA) (Drug)
Group A - phototherapy only
Infants who have indirect hyperbilirubinemia recieve continuous triple phototherapy only .
干预措施: Phototherapy (Procedure)
Group B - phototherapy + UDCA
Phototherapy + UDCA
干预措施: Phototherapy (Procedure)
结局指标
主要结局
Reduction of total serum bilirubin to below phototherapy threshold
时间窗: Day 0 to Day 7
Measurement of serum total bilirubin levels every 12 hours until they fall below the phototherapy threshold based on gestational age and postnatal age. Outcome is considered achieved once bilirubin levels drop below threshold and phototherapy can be discontinued .
Time to bilirubin reduction below treatment threshold
时间窗: Day 0 to Day 7
Time (in hours) from treatment initiation to TSB falling below phototherapy threshold in each group.
Mean reduction in total serum bilirubin at 12 hours
时间窗: 12 hours of starting therapy
To compare the average decrease in total serum bilirubin after 12 hours between the two groups.
次要结局
- Comparison of Hospital stay between both groups(Day 0 to Day 7)
- Comparison of bilirubin reduction between late preterm (34weeks-36weeks+6 days) and term infants (≥37 weeks) in each treatment group.(Up to 7 Days)
- Comparison of bilirubin decline in each gestational age group (preterm vs preterm) and (term vs term) across jaundice types between treatment arms.(Day 0 to Day 7.)
- Need for retreatment(Day 0 to Day 10 , Up to 3 days after treatment discontinuation.)
- Incidence of adverse effects in the UDCA group(Day 0 to Day 7)
- Time to bilirubin normalization in each gestational age group across jaundice types(Up to 7 Days.)
- Time to bilirubin reduction below threshold between treatment groups within each gestational age category(Up to 7 Days)
- Time to bilirubin reduction between late preterm and term neonates within each treatment group(Up to 7 Days)
研究者
Ashraf Maan Alshelly
MD, Pediatric Resident
Tishreen University Hospital