Non-Cardiac Pulmonary Arterial Hypertension in Infants Presenting with Respiratory Distress: Assessing the Efficacy of Thiamine Supplementation in a Clinical Setting
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).â€
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
Mampy Das
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences
