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CTRI Number  CTRI/2024/09/073757 [Registered on: 11/09/2024] Trial Registered Prospectively
Last Modified On: 06/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of the addition of thiamine to Standard Care for treating Pulmonary Arterial Hypertension in Infants 
Scientific Title of Study   Non-Cardiac Pulmonary Arterial Hypertension in Infants Presenting with Respiratory Distress: Assessing the Efficacy of Thiamine Supplementation in a Clinical Setting 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mampy Das 
Designation  Assistant Professor Paediatrics 
Affiliation  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS) 
Address  Department of Paediatrics, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS) Shillong, Mawdiangdiang

East Khasi Hills
MEGHALAYA
793018
India 
Phone  8399870918  
Fax    
Email  mampydas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mampy Das 
Designation  Assistant Professor Paediatrics 
Affiliation  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS) 
Address  Department of Paediatrics, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS) Shillong, Mawdiangdiang

East Khasi Hills
MEGHALAYA
793018
India 
Phone  8399870918  
Fax    
Email  mampydas@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mampy Das 
Designation  Assistant Professor Paediatrics 
Affiliation  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS) 
Address  Department of Paediatrics, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS) Shillong, Mawdiangdiang

East Khasi Hills
MEGHALAYA
793018
India 
Phone  8399870918  
Fax    
Email  mampydas@gmail.com  
 
Source of Monetary or Material Support  
Institutional Intramural grant; North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS), Shillong, Mawdiangdiang, East Khasi Hills, Meghalaya, India - 793018 
 
Primary Sponsor  
Name  Mampy Das 
Address  Department of Pediatrics, North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS), Shillong, Mawdiangdiang, East Khasi Hills, MEGHALAYA - 793018 India 
Type of Sponsor  Other [Principal Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mampy Das  North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS)  Department of Paediatrics, Paediatric Intensive Care Unit (Room A4) and Paediatric General Ward (Room B4)
East Khasi Hills
MEGHALAYA 		 8399870918

mampydas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NORTH EASTERN INDIRA GANDHI REGIONAL INSTITUTE OF HEALTH AND MEDICAL SCIENCE, SHILLONG, INSTITUTION ETHICS COMMITTEE, NEIGRIHMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E518||Other manifestations of thiamine deficiency,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 Arterial Hypertension. Thiamine will be given at a dose of 100mg/day via intravenous infusion over 60minutes for three consecutive days 
Comparator Agent  Standard Care for management of Pulmonary Arterial Hypertension  Standard Care (Oxygen and Sildenafil) for the management of Pulmonary Arterial Hypertension will be given to the patients in the control arm. Oxygen will be supplemented via invasive (Mechanical Ventilation) or non-invasive (nasal prongs/ Face mask/ Continuous Positive Airway Pressure/ Heated Humidified High Flow Nasal Canula) methods. The choice of method of oxygen supplementation will depend upon the requirement of the patient to maintain SpO2 above 90% and to alleviate any increased work of breathing. For this, the flow rate, frequency, route of administration and duration will vary from person to person. However, the duration of Oxygen supplementation will not exceed 72 hours for the study duration of this project. Sildenafil will be given orally at a dose of 0.5mg/kg/dose every 8 hours for 3 consecutive days. 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  12.00 Month(s)
Gender  Both 
Details  Infants aged 1 month to 12 months presenting with respiratory distress, as evidenced by signs such as tachypnea, retractions, grunting, or cyanosis 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Resolution of Pulmonary Arterial Hypertension   72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Impact of thiamine supplementation on the need for oxygen therapy  72 hours 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mampydas@gmail.com].

  6. For how long will this data be available start date provided 01-07-2027 and end date provided 30-06-2037?
    Response (Others) -  Immediately following publication and 10 years following article publication

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Our project aims to investigate Pulmonary Arterial Hypertension (PAH) in hospitalized infants aged 1 to 12 months, without heart problems, and determine if treating them with Vitamin B1 (Thiamine) improves their condition. Using Echocardiography (ECHO), we’ll identify infants with PAH and test their blood for Thiamine levels.

 

Currently, the Standard Care for treating PAH is giving Oxygen and a medicine called Sildenafil. Interestingly, some case series have reported that giving thiamine is beneficial in treating PAH in infants who do not have any obvious causes like heart or lung issues. However, Thiamine isn’t yet a standard treatment for PAH. There are also a few reports stating that thiamine deficiency is still quite common in Northeast India. Therefore we want to examine the effect of thiamine on PAH and explore if thiamine will be an effective adjunct therapy for PAH. 

 

For this, we’ll split our selected patients into two equal groups: One group will receive Standard Care alone and the other group Standard Care with the addition of thiamine. The test results of thiamine levels is expected to take approximately 4-5 days to come. In the meantime, we propose to randomly give thiamine to one group alongwith the Standard Care. We will repeat the ECHO at 12, 24, 48 and 72 hours. After 72 hours, if some of the children who did not receive thiamine earlier still have PAH, then we will try thiamine in them too. Our goal is to see whether the group who received thiamine on top of Standard Care had a better response to PAH or not. Now, if the thiamine blood test results come back before 72 hours then the patient will immediately receive thiamine if not given earlier and response monitored as mentioned earlier.

 

If we can demonstrate a positive response of PAH to thiamine, then it could become a part of the standard treatment for infant PAH.

 

 

 

 

 

 

 

 

 
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