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临床试验/CTRI/2024/09/073873
CTRI/2024/09/073873尚未招募2 期

Non-Cardiac Pulmonary Arterial Hypertension in Infants Presenting with Respiratory Distress: Assessing the Efficacy of Thiamine Supplementation in a Clinical Setting

Individual Principal Investigator Name Mampy Das1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2024年11月11日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
22
试验地点
1
主要终点
Resolution of Pulmonary Arterial Hypertension

研究概览

简要总结

The project aims to investigate the efficacy of thiamine supplementation in resolving non-cardiac Pulmonary Arterial Hypertension (PAH) in infants with respiratory distress. Conducting a randomized controlled trial (RCT) in Northeast India, where there’s a lack of data, the study seeks to establish a causal relationship between thiamine supplementation and PAH resolution. By addressing confounding factors and measuring thiamine levels, the research aims to influence clinical decision-making, potentially establishing thiamine supplementation as a standard therapeutic approach for non-cardiac PAH in infants, thus improving patient outcomes and care quality.  Our Research hypothesis is that“A significant proportion of infants aged 1month to 12months admitted to our tertiary care hospital presenting with respiratory distress (P) have pulmonary arterial hypertension (PAH) of non-cardiac origin, which have good response to thiamine supplementation (I) leading to a higher rate of resolution of PAH (O) at the end of 72hours (T) within the designated study period compared to infants receiving standard care alone (C).”

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
1.00 Month(s) 至 12.00 Month(s)(—)
性别
All

入选标准

  • Infants aged 1month to 12months presenting with respiratory distress, as evidenced by signs such as tachypnea, retractions, grunting, or cyanosis.

排除标准

  • The project has two sets of exclusion criteria:
  • Exclusions before enrollment to the prevalence study: i.Infants diagnosed with structural heart defects except a small (less than 5mm) atrial septal defect or a small (less than 2mm) patent foramen ovale.
  • Infants diagnosed with chronic lung disease.
  • Exclusions to the intervention study: i.Infants who have recently received supplementation with thiamine containing Multivitamins.
  • Patient on predominantly formula feeds.

结局指标

主要结局

Resolution of Pulmonary Arterial Hypertension

时间窗: At 72 hours

次要结局

  • Impact of thiamine supplementation on clinical outcomes, including oxygenation and heart rate(At 72 hours)

研究者

发起方
Individual Principal Investigator Name Mampy Das
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Mampy Das

North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences

研究点 (1)

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