跳至主要内容
临床试验/CTRI/2024/04/065447
CTRI/2024/04/065447招募中不适用

A prospective single centre study of correlation between inflammatory markers and various severity grades of meconium aspiration syndrome (mas) & their outcome

Bhaktivedanta Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2024年4月16日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
69
试验地点
1
主要终点
Changes in the inflammatory markers with severity grades of MAS.

研究概览

简要总结

This is prospective, single centre , observational study at Bhakti Vedanta Hospital and research institute. Full term and post term neonates with meconium-stained amniotic fluid and MAS patients reqiring nicu admission are included. patients will be excluded based on the exclusion criteria. Inflammatory markers at 24, 48hrs and 5th day of life will obtained and at 48hrs for those who do not require nicu admission.  Changes in the inflammatory markers with severity grades of  MAS and various outcome parameters will be observed as primary outcome. Coincidence of sepsis with MAS with their respective inflammatory markers will be studied. Value of inflammatory markers in masf not requiring nicu admission will be studied.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 5.00 Day(s)(—)
性别
All

入选标准

  • Term and post term neonates with meconium stained amniotic fluid &/or MAS will be included.

排除标准

  • 1.Preterms 2.Term neonates with:Transient tachypnoea of new-born, Hypoxic ischemic encephalopathy, congenital heart disease, congenital defects of any other organ, Inborn Error of metabolism surgical Pathology, New-born with hyaline membrane disease Infant of diabetic mother, Polycythaemia New born with respiratory distress with any other etiology or confounding factors other than MAS.

结局指标

主要结局

Changes in the inflammatory markers with severity grades of MAS.

时间窗: 24hrs, 48hrs, 5th day of birth

Value of inflammatory markers in respect to outcome parameters- nicu stay of child, associated complications-PPHN, pnemothorax, O2days,Ventilator days, cpap days,inotropes days, need of surfactant, need of HFO, ECMO, history of fetal distress, APGAR score at 1min and 5 mins.

时间窗: 24hrs, 48hrs, 5th day of birth

次要结局

  • 1.coincidence of sepsis with MAS with their respective inflammatory markers(2.value of inflammatory markers in MSAF)

研究者

发起方
Bhaktivedanta Hospital and Research Institute
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Deepali shukla

Bhaktivedanta Hospital and Research Institute

研究点 (1)

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