Efficacy of Intermittent Phototherapy in Pathological Unconjugated Hyperbilirubinemic Neonates of More Than or equal to 35 Weeks of Gestation – a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of fall of TSB measured as mg/dL/h and mg/dL/h/mg of TSB after initial 24 hours of PT
研究概览
简要总结
Phototherapy is the most frequently used non-invasive modality of treatment for neonatal hyperbilirubinemia, acts by creating pathways for excretion without conjugation of bilirubin. Because of high quantum yield ,the isomerised form (4z,15E) is rapidly accumulated and at commonly used irradiances, PSS (photostationary state) can be reached in the blood of infants within a few hours of phototherapy. Once PSS reached,absorbed light just shuttles the configuaration back and forth and is wasted with regard to phototherapy. So,intermittent phototherapy is equally efficacious to continuous one.Limited data is available globally and India about the efficacy of intermittent phototherapy in pathological unconjugated hyperbilirubinemia in late preterm and term neonates.Present study attempts to evaluate whether intermittent phototherapy is as effective as continuous phototherapy with least side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 0.00 Day(s) 至 14.00 Day(s)（—）
- 性别
- All
入选标准
- •1.Gestational age more than or equal to 35 weeks, if not ascertainable admission weight >2.4 kg.
- •2.Clinical jaundice appearing after 24 h of life.
- •3.Babies with total serum bilirubin (TSB) in the phototherapy range as per clinical Practice Guidelines AAP 2022
- •TSB<2mg/dl below the threshold for exchange transfusion.
- •5.Rate of rise of TSB after 6 hours of initial phototherapy less than or equal to 0.2mg/dl/h.
排除标准
- •1.Major congenital malformations 2.Babies having neurotoxicity risk factors before enrollment(CPG AAP 2022) a) Serum albumin <3gm/dL b)Isoimmune hemolytic disease c)Sepsis(sepsis requiring treatment with antibiotic) d)Clinical instability in previous 24 hours(cardiopulmonary instability,hypotension requiring pressure support, blood PH <7.15,any respiratory support,sepsis) 3.Direct bilirubin more than 15% or more than 1.5mg/dL of TSB.
- •4.Baby received PT for more than 5 h before admission.
结局指标
主要结局
Rate of fall of TSB measured as mg/dL/h and mg/dL/h/mg of TSB after initial 24 hours of PT
时间窗: 0-28 days
次要结局
- Rate of rise of TSB measured as mg/dL/h and mg/dL/h/mg of TSB during entire duration of PT(0-28 days)
- Rate of rise of TSB more than or equal to 0.2mg/dl/hr(0-28 days)
- Rebound of TSB at 12 h of discontinuation of phototherapy(0-28 days)
- Baby requiring escalation of care during phototherapy(0-28 days)
- Baby requiring Exchange transfusion(0-28 days)
- Baby developing BIND(bilirubin induced neurological dysfunction)(0-28 days)
- Change in serum Electrolytes (sodium,potassium,calcium)(0-28 days)
- Change in Platelet count(0-28 days)