FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/066151 [Registered on: 23/04/2024] Trial Registered Prospectively
Last Modified On: 22/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Failure of non-invasive intermittent positive pressure ventilation  
Scientific Title of Study   Incidence , Risk factors for Failure of non-invasive intermittent positive pressure ventilation in preterm infants with respiratory distress syndrome in level III NICU – a prospective observational 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  Dr Sonali Amol Avale 
Designation  Senior Resident 
Affiliation  Government Medical college , Sambhaji Nagar 
Address  Department of Neonatology , Government Medical college , Sambhaji Nagar

Aurangabad
MAHARASHTRA
431001
India 
Phone  9850584999  
Fax    
Email  sonaliawale1193@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Laxmikant Deshmukh 
Designation  Head of Department of Neonatology 
Affiliation  Government Medical college , Sambhaji Nagar 
Address  Department of Neonatology , Government Medical college , Sambhaji Nagar

Aurangabad
MAHARASHTRA
431001
India 
Phone  9822478275  
Fax    
Email  deshmukhls@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Laxmikant Deshmukh 
Designation  Head of Department of Neonatology 
Affiliation  Government Medical college , Sambhaji Nagar 
Address  Department of Neonatology , Government Medical college , Sambhaji Nagar

Aurangabad
MAHARASHTRA
431001
India 
Phone  9822478275  
Fax    
Email  deshmukhls@yahoo.com  
 
Source of Monetary or Material Support  
GOVERNMENT MEDICAL COLLEGE, AURANGABAD 
 
Primary Sponsor  
Name  Dr Sonali Amol Avale 
Address  Department of Neonatology , Government Medical college , Sambhaji Nagar 
Type of Sponsor  Government medical college 
 
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 Sonali Amol Avale  Department of Neonatology , Government Medical college , Sambhaji Nagar  Department of Neonatology , Government Medical college , Sambhaji Nagar
Aurangabad
MAHARASHTRA 
9850584999

sonaliawale1193@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institunal Ethics Committee, Government Medical College, Sambhajinagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P220||Respiratory distress syndrome of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  1.00 Day(s)
Gender  Both 
Details  • Gestational age (GA) between 26 and less than 37 weeks weeks. GA will be determined by dates or a dating ultrasound.
• Clinical and radiological Diagnosis of RDS -The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring, and or grunting and chest Xray suggestive of RDS
 
 
ExclusionCriteria 
Details  1.Any baby intubated for resuscitation or for other reasons.
2. Major congenital malformations or known complex congenital heart disease
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study incidence, risk factors of noninvasive intermittent positive pressure ventilation (NIPPV) failure, defined as the need for intubation within 72 hours of life  First 72 hours of life 
 
Secondary Outcome  
Outcome  TimePoints 
1. Days of hospitalization,
2. Days on NIV,
3. Days on supplemental oxygen,
4. Pre-discharge mortality,
5. Surfactant doses,
6. Retinopathy of prematurity,
7. Bronchopulmonary dysplasia ,
8. Abdominal distention, feed intolerance, time to full feed, air leaks
9. Intraventricular hemorrhage ,
10. Spontaneous intestinal perforation,
11. Presence of thick secretions causing an airway obstruction 
Death
Discharge 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   07/05/2024 
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="1"
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 - NO
Brief Summary  

RDS is a common cause of morbidity and mortality in preterm infants, with  severe diseases in smaller and more premature neonates. The objective of respiratory management of preterm infants with  risk of RDS is to maximize survival while minimizing potential adverse effects, such as bronchopulmonary dysplasia (BPD). The 2019 European Consensus Guidelines on the management of RDS recommend the early use of continuous positive airway pressure (CPAP) of at least 6 cm H2O in all babies at risk of RDS who do not need intubation for delivery room stabilization . Early initiation of CPAP potentially reduces the need for mechanical ventilation and surfactant replacement while improving clinical outcomes. RDS management has evolved dramatically over the last decade, almost half of the infants who are started on CPAP fail this therapy and are ultimately intubated . It should be noted that CPAP failure is associated with an increased risk of death and morbidities, including BPD and pneumothorax .Studies have shown that birth weight and male gender are risk factors for CPAP failure . To mitigate CPAP failure, and in parallel with technological advances in the field of neonatal ventilators, different modes of non-invasive ventilation (NIV) have been introduced, with nasal intermittent positive-pressure ventilation (NIPPV) being the most frequently used alternative. Multiple studies have studied CPAP failure but very few studies on NIPPV failure.

    

 
Close