跳至主要内容
临床试验/CTRI/2024/07/070378
CTRI/2024/07/070378尚未招募不适用

A prospective study of association of bilirubin and albumin ratio on the immediate outcome of neonatal hyperbilirubinemia

Datta Meghe Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2024年7月12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
55
试验地点
1
主要终点
duration of phototherapy significantly correlates to the bilirubin and albumin ratio

研究概览

简要总结

Neonatal jaundice is one of the most common issues of neonates.THE incidence of neonatal jaundice in India varies from 54.6% to 77% .  Although mostly physiological, sometimes it can result in irreversible bilirubin encephalopathy if not recognised, which becomes the concern factor for a developing brain. Out of various treatment modalities available for neonatal jaundice, phototherapy is widely used.  The study will be carried out in neonates with clinical jaundice requiring phototherapy and admitted to the neonatal intensive care unit (NICU) both inborn & outborn of AVBRH, Datta Meghe Institute of Higher Education and Research. The neonates satisfying the inclusion criteria will be included in the study after procuring consent from the parents on a pre-validated informed consent proforma.  All the babies after 24 hours of life will be screened for Neonatal Jaundice using total serum bilirubin values.Newborns with Conjugated Hyperbilirubinemia, co-morbidities like acute renal failure, Hydrops foetalis, congenital nephritic syndrome, and other diseases that mimic BIND as well as death due to other reasons will be excluded from the study.

If albumin levels are normalised in the initial phases of treatment for neonatal hyperbilirubinemia , the neurological impact can be reduced.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Day(s) 至 30.00 Day(s)(—)
性别
All

入选标准

  • All the Neonates admitted in NICU receiving phototherapy for hyperbilirubinemia after 24 hours of life.

排除标准

  • Neonates with Conjugated Hyperbilirubinemia.
  • Neonates with co-morbidities like acute renal failure, Hydrops foetalis, congenital nephritic syndrome, and other diseases that mimic BIND as well as death due to other reasons.

结局指标

主要结局

duration of phototherapy significantly correlates to the bilirubin and albumin ratio

时间窗: 24 hours

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sai Bhavani M

Datta Meghe Institute of Medical sciences, Wardha

研究点 (1)

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