| CTRI Number |
CTRI/2025/10/095995 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
12/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two types of breathing devices for preterm babies admitted in NICU. |
|
Scientific Title of Study
|
Comparison Of Bubble CPAP (Variable Flow CPAP) Vs Pressure Sources Of CPAP In Preterm Infants An Open Labelled Randomized Controlled Trial. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Cosmica Shah |
| Designation |
Post graduate trainee |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Pediatrics AIIMS Bhopal AIIMS Road, Saket Nagar Habib Ganj Bhopal
Bhopal
MADHYA PRADESH 462020
India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8235852195 |
| Fax |
|
| Email |
dr.cosmicashah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Shikha Malik |
| Designation |
Professor |
| Affiliation |
AIIMS Bhopal |
| Address |
Room No:H-1001 Department of Pediatrics AIIMS Bhopal AIIMS Road,Saket Nagar Habib Ganj Bhopal
Bhopal
MADHYA PRADESH 462020
India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9425018080 |
| Fax |
|
| Email |
shikha.pediatrics@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chetan Khare |
| Designation |
Assistant Professor Neonatology |
| Affiliation |
AIIMS Bhopal |
| Address |
Room No:2005 Department of Neonatology AIIMS Bhopal AIIMS Road,Saket Nagar Habib Ganj Bhopal
Bhopal
MADHYA PRADESH 462020
India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9843395041 |
| Fax |
|
| Email |
drchetankhare@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhopal, Saket Nagar Habib Ganji Madhya Pradesh 462020 India |
|
|
Primary Sponsor
|
| Name |
AIIMS Bhopal |
| Address |
AIIMS Bhopal AIIMS Road,Saket Nagar Habib Ganj,AIIMS Bhopal Bhopal 462020 |
| 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 Cosmica Shah |
AII India Institute of Medical sciences Bhopal |
Department Of Neonatology All Indian Institute Of Medical Sciences Bhopal, Saket Nagar Bhopal, Madhya Pradesh Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH |
8235852195
dr.cosmicashah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee -Student Research |
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 (Variable flow CPAP system.) |
In this mode, continuous positive airway pressure is delivered to the preterm infant through a bubble CPAP circuit. The expiratory limb of the circuit is submerged in water at a preset depth, and the bubbling generates oscillations that may improve lung recruitment and gas exchange. The pressure delivered is flow-dependent, and the infant breathes spontaneously against a constant distending pressure. The intervention is done till patient stabilization. |
| Comparator Agent |
Other CPAP pressure sources |
CPAP from Conventional Pressure Sources eg ventilator derived CPAP, pressure modes of CPAP. In this, mode, CPAP is provided using a conventional ventilator or a stand alone breathing device which provides a continuous distending inspiratory pressure at a fixed set level throughout the respiratory cycle. The intervention is done till patient stabilization. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Preterm (less than 37 completed weeks at birth) who develop early onset respiratory distress requiring CPAP within 6 hours of birth. |
|
| ExclusionCriteria |
| Details |
1. Surgical anomalies of chest and abdomen
2. Syndromic newborns
3. Preterm infants who require delivery room intubation and early surfactant replacement therapy.
4. Perinatal asphyxia with encephalopathy or cord pH < 7
5. Pneumothorax or air-leaks prior to enrolment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.CPAP failure in the first 72 hours of birth
2.Need of mechanical ventilation
3.Incidence of hypoxic respiratory failure
|
baseline data, 1 day, 3 days. 7 days, 14 days and 28 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Duration of respiratory support.
2.Need for surfactant replacement therapy
3.Need of vasopressors in first 72 hours
4.Oxygenation assessment by Spo2/Fio2 for the first 72 hours after birth.
5.Incidence of common preterm morbidity like BPD, IVH, PDA,ROP,NEC, ect.
6.Incidence of complications of nasal trauma & air leaks.
7.Duration of oxygen supplementation.
|
baseline, 1 day, 3 days, 7 days, 14 days & 28 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/12/2025 |
| 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 Yet Recruiting |
| 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
|
Respiratory distress syndrome (RDS) is the most common pulmonary aliment in preterm newborns, and the incidence may reach up to 80 per cent in the extreme preterm populations (less than 28 weeks). With the antenatal corticosteroid in preterm pregnancy, early onset respiratory distress in preterm newborns is supported with continuous positive airway pressure support (CPAP) which has gained popularity due to its low cost, non- invasive respiratory support. Following the widespread adoption of these interventions over the past several decades, the principle from of respiratory support for preterm infants with or at risk of RDS has moved from mechanical ventilation via an endotracheal tube to non- invasive ventilation. However, given the level of certainty about the effect of bubble CPAP versus other pressure sources on the risk of treatment failure and most associated morbidity and mortality for preterm infants, further trials are needed to provide evidence of sufficient validity and practice. This trial aims at comparing the two common varieties of CPAP for their clinical outcomes as the primary mode of respiratory therapy. |