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CTRI Number  CTRI/2025/07/092022 [Registered on: 30/07/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Pulmonary hypertension phenotypes in neonates - A prospective cohort study 
Scientific Title of Study   Evaluation of a physiologic phenotype-based algorithm in diagnosis and classification of pulmonary hypertension in neonates – A prospective cohort study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Murugesan A 
Designation  Assistant professor 
Affiliation  JIPMER 
Address  Deaprtment of Neonatology, WCH block, 2 nd floor, JIPMER, Gorimedu, Dhanvantari Nagar.

Pondicherry
PONDICHERRY
605006
India 
Phone  9442455767  
Fax    
Email  murugesan89@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Murugesan A 
Designation  Assistant professor 
Affiliation  JIPMER 
Address  Deaprtment of Neonatology, WCH block, 2 nd floor, JIPMER, Gorimedu, Dhanvantari Nagar.

Pondicherry
PONDICHERRY
605006
India 
Phone  9442455767  
Fax    
Email  murugesan89@gmail.com  
 
Details of Contact Person
Public Query  
Name  Murugesan A 
Designation  Assistant professor 
Affiliation  JIPMER 
Address  Deaprtment of Neonatology, WCH block, 2 nd floor, JIPMER, Gorimedu, Dhanvantari Nagar.

Pondicherry
PONDICHERRY
605006
India 
Phone  9442455767  
Fax    
Email  murugesan89@gmail.com  
 
Source of Monetary or Material Support  
JIPMER, Gorimedu, Dhanvantari Nagar, Puducherry - 605006 
 
Primary Sponsor  
Name  JIPMER 
Address  JIPMER, Gorimedu, Dhanvantari Nagar. 
Type of Sponsor  Research institution and hospital 
 
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 
MURUGESAN A  Jawaharlal Institute of Postgraduate Medical Education and Research  NICU, Deaprtment of Neonatology, WCH block, 1 st floor, JIPMER, Gorimedu, Dhanvantari Nagar.
Pondicherry
PONDICHERRY 		 9442455767

murugesan89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P288||Other specified respiratory conditions of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Inclusion criteria: Neonates admitted to NICU with
a diagnosis of echo-proven PH. 
 
ExclusionCriteria 
Details  Exclusion criteria: Neonates with structural heart
disease other than patent ductus arteriosus (PDA). Major congenital malformations. Neonates who die within 24 hours of life. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the proportion of different identifiable
PH phenotypes (flow driven, resistance driven, post- capillary, or mixed) in neonates with pulmonary
hypertension 		 Primary outcome can occur at any point of time until death or discharge from hospital. The time point might be anywhere between Day 1 of life to day 28 of life, based on when the outcome occurs 
 
Secondary Outcome  
Outcome  TimePoints 
1. To analyze the factors associated with
mortality in PH
2. To analyze the differences in phenotype and
echo parameters between term & preterm
infants with PH
3. To estimate the survival to discharge rates in
neonates with PH 		 The above mentioned secondary outcomes can occur at any point of time until death or discharge from hospital. The time point might be anywhere between Day 1 of life to day 28 of life, based on when the outcome occurs 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   N/A 
Date of First Enrollment (India)   15/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/08/2025 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [murugesan89@gmail.com].

  6. For how long will this data be available start date provided 15-08-2025 and end date provided 15-08-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Background: Persistent pulmonary hypertension (PPHN) is a syndrome of failure of transition from fetal to neonatal circulation. The incidence of PPHN is 0.5-6 per 1000 livebirths in term infants, and around 8% in preterm infants < 28 weeks. In low- and middle-income countries (LMICs), the incidence is unknown due to lack of shared databases/registries. Moreover, pulmonary hypertension (PH) secondary to other causes like infections, heart diseases are sometimes mislabeled as PPHN. Also, standard treatment options like inhaled nitric oxide (iNO) are unavailable in many centers. It is important to understand the burden of the problem in LMICs to guide targeted management 

Rationale: Due to complex cardio-respiratory interactions in the immediate postnatal life, PPHN is common in neonates. Common etiologies for this aberrant perinatal transition include: meconium aspiration syndrome (MAS), perinatal asphyxia, RDS, pneumonia, sepsis, fetal growth restriction (FGR) and congenital diaphragmatic hernia (CDH) . Though an etiology-based classification helps in anticipating PH in these neonates, it is often not enough to guide management. A physiologic phenotype driven algorithm helps in classifying PH states based on patterns like: flow-driven, resistance driven, post-capillary or a combination of patterns. Unlike etiology-driven identification, phenotype- based patterns help in guiding management, which is why the present study is being planned. 

Novelty: Treatment options and outcomes in major clinical trials are guided by indices like oxygenation index (OI), and peak systolic pulmonary pressures, which are non-specific and may be affected by other disease states like parenchymal disease, and heart disease. A phenotype-based algorithm has not been studied in PH. 

Expected outcome and application: A physiology/ phenotype-based approach will guide appropriate management of PH, against the conventional guideline-based management. Analyzing the natural course of PH phenotypes will help in identifying those at highest risk of mortality, and thus help in titrating management accordingly.
 
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