A clinical trial to study the effect of the addition of thiamine to Standard Care for treating Pulmonary Arterial Hypertension in Infants

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/09/073757

Enrollment

Registered

2024-09-11

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E518- Other manifestations of thiamine deficiency

Interventions

Intervention1: Addition of Thiamine to Standard Care for management of Pulmonary Arterial Hypertension: Thiamine will be added to Standard Care (Oxygen and Sildenafil) for the management of Pulmonary

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: The project has two sets of exclusion criteria: 1. 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. ii. Infants diagnosed with chronic lung disease. 2. Exclusions to the intervention study: i.Infants who have recently received supplementation with thiamine containing Multivitamins. ii. Patient on predominantly formula feeds.

Design outcomes

Primary

Measure	Time frame
Resolution of Pulmonary Arterial HypertensionTimepoint: 72 hours	—

Secondary

Measure	Time frame
Impact of thiamine supplementation on the need for oxygen therapyTimepoint: 72 hours	—

Countries

India

Contacts

Public ContactMampy Das

North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS)

mampydas@gmail.com8399870918

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026