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临床试验/CTRI/2025/07/090068
CTRI/2025/07/090068尚未招募不适用

Correlation of Clinical and USG lung in newborns born after 34 weeks of gestation age with respiratory distress : a prospective observational study at a Tertiary Care Center in Eastern India.

Neotia Bhagirathi Woman and Child Care Centre1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年7月15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
150
试验地点
1
主要终点
1. Respiratory Distress Scoring(DOWNE score)

研究概览

简要总结

Our project Titled “Correlation of Clinical and USG lung in newborns born after 34 weeks of gestation age with respiratory distress : a prospective observational study at a Tertiary Care Center in Eastern India.” which is a unicentric study , at Bhagirathi Neotia Woman and Child Care Centre, Newtown, Kolkata. This study aims to look at the correlation between ultrasound lung findings and clinical features. If a good correlation is found then USG can replace chest X-ray as a modality of diagnosis in newborns with respiratory distress. Chest X-ray we know involves radiation exposure.

The total number of cases that are proposed to be enrolled is 150 over a period of 12 months which will be feasible at the Bhagirathi Neotia Woman and Child Care Centre, Newtown, Kolkata in the above period.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • 1.Completed 34 wks weeks of gestational age.
  • 2.Onset of respiratory distress within 6 hrs of birth.

排除标准

  • 1.Congenital Heart Disease(Either Diagnosed Antenatally or postnatally) 2.Congenital malformation incompatible with life.
  • 3.Pneumothorax and other forms of air leaks like pneumomediastinum.

结局指标

主要结局

1. Respiratory Distress Scoring(DOWNE score)

时间窗: Baseline and 24 hours later

2. USG scoring to assess the prognosis of disease pathology.

时间窗: Baseline and 24 hours later

3. Correlation between USG score and Downe score

时间窗: Baseline and 24 hours later

4. Correlation between USG and Chest X-Ray finding

时间窗: Baseline and 24 hours later

5. Correlation between Chest X-ray and Downe scoring

时间窗: Baseline and 24 hours later

6. Chest X-Ray finding.

时间窗: Baseline and 24 hours later

次要结局

  • 1. Duration of Oxygen requirement.(In hours)(2. Duration of Ventilation.(In hours))

研究者

发起方
Neotia Bhagirathi Woman and Child Care Centre
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr. Archisman Mondal

Neotia Bhagirathi Woman and Child Care Centre

研究点 (1)

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