| CTRI Number |
CTRI/2025/11/098134 [Registered on: 27/11/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Bubble CPAP versus Ventilator CPAP in premature babies |
|
Scientific Title of Study
|
A randomised controlled trial comparing the efficacy of Bubble Continuous Positive Airway Pressure (B-CPAP) and Ventilator Continuous Positive Airway Pressure (V-CPAP) in preterm neonates with respiratory distress |
| 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 Devi Pilakkal Gangadharan |
| Designation |
Post Graduate |
| Affiliation |
JSS Medical College,JSS Academyof Higher Education and Research |
| Address |
Neonatal Intensive cCare Unit,Deapartment ofPaediatrics,2nd floor,JSS Hospital,MG Road, Ramachandra Agrahara,Mysore
Mysore
KARNATAKA
570004
India |
| Phone |
9605422167 |
| Fax |
|
| Email |
devigang410@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepti Thandaveshwar |
| Designation |
Associate Professor |
| Affiliation |
JSS Medical College |
| Address |
Neonatal Intensive cCare Unit,Deapartment ofPaediatrics,2nd floor,JSS Hospital,MG Road, Ramachandra Agrahara,Mysore
Mysore
KARNATAKA
570004
India |
| Phone |
9845023309 |
| Fax |
|
| Email |
deeptiadarsh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepti Thandaveshwar |
| Designation |
Associate Professor |
| Affiliation |
JSS Medical College |
| Address |
Neonatal Intensive cCare Unit,Deapartment ofPaediatrics,2nd floor,JSS Hospital,MG Road, Ramachandra Agrahara,Mysore
Mysore
KARNATAKA
570004
India |
| Phone |
9845023309 |
| Fax |
|
| Email |
deeptiadarsh@gmail.com |
|
|
Source of Monetary or Material Support
|
| JSS Hospital,MG Road,Mysore 570004 |
|
|
Primary Sponsor
|
| Name |
Dr Devi Pilakkal Gangadharan |
| Address |
Department of Paediatrics,2nd floor,JSS Hospital,Mysore 570004 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Devi Pilakkkal Gangadharan |
JSS Hospital |
Neonatal Intensive Care Unit,2 nd floor, JSS Hospital,MG Road,Ramachandra Agrahara,Mysore
Mysore
KARNATAKA |
9605422167
devigang410@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Intervention |
Bubble CPAP |
Bubble CPAP (Fischer and Paykel company)adminitered through nasal prongs till the condition improves or needs escalation to the next step of management |
| Comparator Agent |
Ventilator CPAP |
Ventilator CPAP administered through prongs in babies with respiratory till the condition improves or needs escalation to the next step of management |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
3.00 Day(s) |
| Gender |
Both |
| Details |
Neonates less than 72 hours of age and born between 28 and 36 weeks and 6 days of gestation with respiratory distress (Downe’s score more than or equal to 3) will be included in the study. |
|
| ExclusionCriteria |
| Details |
Babies with either of the following will be excluded:
1. Congenital diaphragmatic hernia
2. Severe external congenital anomalies
3. Cardiac defects
4. Any respiratory support given outside hospital apart from oxygen
5. Surgical cases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the CPAP success rate between Bubble CPAP and Ventilator CPAP as the initial mode of respiratory support for preterm babies with respiratory distress.
|
72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the change in SOPI between bubble CPAP and Ventilator CPAP as the initial mode of respiratory support for preterm babies with respiratory distress up to 72 hours after initiation of treatment.
|
72 hours after initiation |
| 2. To compare the adverse outcomes between Bubble CPAP & Ventilator CPAP during the treatment period. |
4-6 weeks |
| 3. To compare the duration of respiratory support among babies treated with either bubble CPAP & ventilator CPAP for respiratory distress. |
4-6 weeks |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
23/12/2025 |
| 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="6"
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
|
Preterm birth remains a major global health issue, causing around 965000 neonatal deaths and 125000 deaths in children under five each year. In 2020, 13.8 million babies were born prematurely, with South East Asia and sub Saharan Africa bearing the highest burden. The early neonatal period is particularly critical, with most deaths occurring during labour or within 24 hours of birth. Prematurity and low birth weight are leading causes of neonatal mortality.
Respiratory distress is the most common complication in preterm infants, often resulting from conditions such as respiratory distress syndrome, congenital pneumonia, or pulmonary hypoplasia. A large cohort study from India and Pakistan found that 23 per cent of preterm neonates died within 28 days, with major causes including maternal hypertension, placental malperfusion, chorioamnionitis, intrauterine hypoxia, congenital and neonatal infections, and respiratory distress syndrome.
CPAP is the first-line respiratory support for preterm infants with spontaneous breathing and signs of distress. It maintains alveolar stability, reduces the work of breathing, and improves gas exchange. Common CPAP methods include Bubble CPAP and Ventilator CPAP. Bubble CPAP generates pressure via a water column, while Ventilator CPAP uses a mechanical ventilator to maintain constant pressure.
Both methods are considered effective and safe, but definitions of CPAP failure vary across studies. This study aims to compare failure rates between Bubble CPAP and Ventilator CPAP as initial respiratory support in preterm infants with respiratory distress.
Research question: Is bubble CPAP more effective than ventilator CPAP for treating respiratory distress in preterm infants? |