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临床试验/CTRI/2024/06/068787
CTRI/2024/06/068787尚未招募不适用

Intermittent versus Continuous phototherapy for neonatal nonhemolytic hyperbilirubinemia in neonates 28 to 34 weeks of gestational age A non inferiority randomized control trial.

Sri Ramachandra Medical College Porur1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年6月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
The rate of fall of serum bilirubin values during the treatment duration

研究概览

简要总结

Neonatal jaundice occurs in 60% term and 80% preterm infants. Continuous Phototherapy(CPT) reduces kernicterus and improves neurodevelopmental outcomes across all gestations. However alterations in mesenteric, cerebral blood flow, DNA damage, risk of carcinogenesis and higher mortality in ELBW babies have been reported. Intermittent Phototherapy(IPT) is a proven non-inferior alternative to CPT in Term and Late Preterm babies. CTRI Registration will be done and the study will be conducted from April 2023-December 2024. With 80 % power and an alpha error of 5 % that indicated intermittent PT is not inferior to continuous PT in terms of rate of fall of bilirubin, 45 neonates will be enrolled in each group with the help of computer generated randomisation. Infants with gestations 28 – 34 weeks of gestations with nonhemolytic hyperbilirubinemia during NICU stay will be enrolled with infants in IPT group receiving  phototherapy for 6 hour cycles. While infants in CPT group will receive phototherapy for 24 hours. Total serum bilirubin (TSB) will be done every 12- 24 h in both groups until criteria for stopping PT is met. Primary outcomes will be -Rate of fall of bilirubin. Data will be presented as number and percentage, mean and standard deviation or median and interquartile range as appropriate. Relevant tests of significance will be applied. Multiple regression analysis will be used to adjust for confounding. p value of <0.05 will be considered statistically significant Intermittent phototherapy may possibly avoid cerebral, splanchnic hemodynamic fluctuations in VLBW infants with preserved skin integrity. Improved KMC hours, decreased mother infant separation can be gained in infants between 28-34 weeks gestation. Finally, it may help NICU to treat more babies with limited phototherapy units across all gestations.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Neonates 28- 34 weeks gestation with non-hemolytic jaundice.

排除标准

  • Septic Shock with systemic instability Major congenital and chromosomal anomalies Severe IVH Culture proven Meningitis Babies on phototherapy for indication other than hyperbilirubinenemia.

结局指标

主要结局

The rate of fall of serum bilirubin values during the treatment duration

时间窗: From the time of starting Phototherapy to 24 hours after

次要结局

  • I.Duration of Phototherapy received to treat non hemolytic hyperbilirubinemia(II.Incidence of “IPT Non respondersâ€)

研究者

发起方
Sri Ramachandra Medical College Porur
申办方类型
Private medical college

研究点 (1)

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