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CTRI Number  CTRI/2024/06/068789 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 09/06/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   survey 
Study Design  Other 
Public Title of Study   Incidence Of Respiratory Dificulties In Full Term Normal Vaginally Delivered Neonates. 
Scientific Title of Study   A Survey Study On the Incidence Of Respiratory Difficulties In Term Neonates.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashish pramod Rana 
Designation  assistant professor 
Affiliation  GAC and H NAGPUR 
Address  dept oF AYURVEDIC pediatrics government ayurved college & hospital nagpur opd no 35

Nagpur
MAHARASHTRA
440028
India 
Phone  9371003581  
Fax    
Email  arana988@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Bhairavi Sudhakar Karve 
Designation  Ug student IV yr BAMS 
Affiliation  GAC and H NAGPUR 
Address  GAC & H NAGPUR
pediatric opd no 35 government ayurved college nagpur
Nagpur
MAHARASHTRA
440028
India 
Phone  9371003581  
Fax    
Email  arana988@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ashish pramod Rana 
Designation  assistant professor 
Affiliation  GAC and H NAGPUR 
Address  Pediatric OPD no 35 GAC & H Nagpur

Nagpur
MAHARASHTRA
440028
India 
Phone  9371003581  
Fax    
Email  arana988@gmail.com  
 
Source of Monetary or Material Support  
CCRAS Delhi UGSpark project ccras 61-65,opp D Block ,Janakpuri institutional Area,janakpuri,new delhi 110058 
 
Primary Sponsor  
Name  CCRAS Delhi 
Address  Central Council for Research in Ayurvedic Sciences 61-65, Institutional Area, Opp. D Block Janakpuri, New Delhi-110058 
Type of Sponsor  Research institution 
 
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 Ashish Rana  Government Ayurved College Nagpur  Opd no 35 balrog Government ayurved college and Hospital Nagpur raje raghuji nagar umred road sakkardara nagpur
Nagpur
MAHARASHTRA 
9371003581

govtayurcollegenagpur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for research on Human Subjects (IEC)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:P289||Respiratory condition of newborn,unspecified. Ayurveda Condition: PRANAVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Day(s)
Gender  Both 
Details  normal vaginal delivered term neonates with respiratory dificulties with unknown reason.
normal vaginal delivered term neonates with respiratory Problem without any maternal cause. 
 
ExclusionCriteria 
Details  delivered neonates with respiratory dificulties with known reason 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To Determine the Incidence of Respiratory Difficulties in term neonates.
2. To Identify Risk Factors for Respiratory Difficulties in term neonates.
3. To Explore the Pathophysiology of TTN According to Ayurveda.

 
At Baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Maternal age, gestational age, birth weight, APGAR score and other Relevant factors will be analysed for potential correlations with respiratory difficulties.  2 months 
 
Target Sample Size   Total Sample Size="59"
Sample Size from India="59" 
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)   21/06/2024 
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="0"
Months="2"
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 - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  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 (Others) -  data will be provided only on approval from necessary authorities.

  6. For how long will this data be available start date provided 16-06-2024 and end date provided 16-05-2028?
    Response - Immediately following publication. No end date.

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

Respiratory difficulties in term neonates constitute a critical aspect of neonatal health, demanding meticulous attention due to their potential impact on overall well-being. According to existing literature, an estimated 4% of term neonates experience respiratory difficulties, emphasizing the need for a comprehensive understanding of the contributing factors and potential interventions8. While advancements in modern medicine have significantly improved neonatal care, the integration of traditional and complementary approaches, such as Ayurveda, offers a nuanced understanding of respiratory health in newborns. This research endeavors to delve into the incidence of respiratory difficulties in term neonates through a survey study, uniquely framed within the holistic principles of Ayurveda.


The neonatal period is a crucial developmental phase marked by physiological adjustments, and any deviation from respiratory norms can have profound consequences. Despite the advancements in medical science, respiratory issues remain a primary cause of neonatal morbidity and mortality. Traditional systems of medicine, like Ayurveda, bring forth ancient wisdom that considers the interconnectedness of physiological, psychological, and environmental factors in health and disease. This study seeks to bridge the gap between conventional medical practices and Ayurvedic principles to comprehensively address respiratory challenges in term neonates. The choice of Ayurveda as a framework for this survey study is motivated by its holistic approach, where health is seen as a balance between body, mind, and spirit. Ayurvedic principles emphasize preventive measures, lifestyle modifications, and natural remedies, offering a unique perspective that complements modern medical interventions. By exploring the incidence of respiratory difficulties in term neonates through an Ayurvedic lens, this research aims to uncover insights that can contribute to a more holistic and integrative approach in neonatal care.


In essence, this study is not just an exploration of statistical trends but a journey into the integration of ancient wisdom with contemporary healthcare practices. It aspires to contribute valuable knowledge that could enhance the understanding of respiratory health in term neonates, paving the way for more holistic and personalized approaches to neonatal care. 


 
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