| CTRI Number |
CTRI/2026/01/100145 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [CPAP] |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing two types of breathing support continuous positive airway pressure for premature babies with breathing problems in a hospital |
|
Scientific Title of Study
|
Conventional CPAP as an alternative to Bubble CPAP as a respiratory support in preterm babies with respiratory distress syndrome – An Interventional comparative study at a tertiary care centre |
| 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 S Madhumetha |
| Designation |
Postgraduate |
| Affiliation |
Vinayaka missions kirupananda variar medical college and research institute |
| Address |
NICU
Department of paediatrics
Vinayaka missions kirupananda variar medical college and research institute
Ariyanoor
Salem
Salem
TAMIL NADU
636006
India |
| Phone |
7010179756 |
| Fax |
|
| Email |
madhusrisen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K Rangasamy |
| Designation |
Professor |
| Affiliation |
Vinayaka missions kirupananda variar medical college and research institute |
| Address |
Vinayaka missions kirupananda variar medical college and research institute
chinnaseeragapadi ariyanur post salem
Salem
TAMIL NADU
636308
India |
| Phone |
9486767266 |
| Fax |
|
| Email |
ramrangsdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
S Madhumetha |
| Designation |
Postgraduate |
| Affiliation |
Vinayaka missions kirupananda variar medical college and research institute |
| Address |
94 Pension line velu street dadagapatty salem
Salem
TAMIL NADU
636006
India |
| Phone |
7010179756 |
| Fax |
|
| Email |
madhusrisen@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
S Madhumetha |
| Address |
94 Pension line velu street dadagapatty salem 636006 |
| Type of Sponsor |
Other [self] |
|
|
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 S Madhumetha |
Vinayaka missions kirupananda variar medical college and research institute |
Paediatrics department
NICU
Ariyanoor salem
Salem
TAMIL NADU |
7010179756
madhusrisen@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: J80||Acute respiratory distress syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CPAP |
Conventional CPAP as an alternative to Bubble CPAP as a respiratory support in preterm babies with respiratory distress syndrome |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
8.00 Month(s) |
| Age To |
9.00 Month(s) |
| Gender |
Both |
| Details |
32 to 34 weeks preterm with respiratory distress syndrome |
|
| ExclusionCriteria |
| Details |
Preterm neonates less than 32 weeks are excluded from the study.
High risk cases such as Cardiovascular, Pulmonary, Coagulopathies ,
Neonates with congenital anomalies and genetic disorders are excluded from the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Conventional CPAP may be as effective as Bubble CPAP in management of Respiratory distress syndrome in preterm infants requiring CPAP
The use of C-CPAP in preterm infants with RDS may not have increase in complications and CPAP failure rates in comparison to B-CPAP.
|
Conventional CPAP may be as effective as Bubble CPAP in management of Respiratory distress syndrome in preterm infants requiring CPAP
The use of C-CPAP in preterm infants with RDS may not have increase in complications and CPAP failure rates in comparison to B-CPAP.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
15/01/2026 |
| 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="2"
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
|
This study compares the effectiveness of Conventional CPAP and Bubble CPAP in preterm neonates 32to34 weeks with Respiratory Distress Syndrome to determine whether Conventional CPAP can serve as an equally effective and cost-efficient alternative in resource-limited settings. It is an interventional comparative study involving 64 infants, evaluating vital parameters, improvement in Modified Downe’s score, complications like abdominal distension and nasal injury, CPAP failure, and NICU stay duration. By analysing these outcomes, the study aims to establish whether Conventional CPAP provides similar clinical benefits and safety when compared with Bubble CPAP, without increasing complications or treatment failure. |