| 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
|
|
|
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
|
|
|
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. |