| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:P289||Respiratory condition of newborn,unspecified. Ayurveda Condition: PRANAVAHASROTOVIKARAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
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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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - data will be provided only on approval from necessary authorities.
- 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.
- 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. |