| CTRI Number |
CTRI/2024/10/075784 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Mode of Ventilation] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of synchronised non invasive positive pressure ventilation to continuous positive airway pressure in preterm neonates |
|
Scientific Title of Study
|
Clinical efficacy of synchronized nasal intermittent positive pressure ventilation versus high continuous positive airway pressure as primary mode of respiratory support in preterm neonates(28-34weeks): a randomized controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhurima Ganguly |
| Designation |
Post doctoral trainee |
| Affiliation |
Institute of Post Graduate Medical Education and Research,Kolkata |
| Address |
Department of Neonatology, Institute of Post Graduate Medical Education and Research, 244 A. J. C. Bose Road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
8584054234 |
| Fax |
|
| Email |
madhuganguly22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ratan Kumar Biswas |
| Designation |
Associate Professor |
| Affiliation |
Institute of Post Graduate Medical Education and Research, Kolkata |
| Address |
Department of Neonatology, Institute of Post Graduate Medical Education and Research, 244 A. J. C. Bose Road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
8697700890 |
| Fax |
|
| Email |
ratansarmistha2011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ratan Kumar Biswas |
| Designation |
Associate Professor |
| Affiliation |
Institute of Post Graduate Medical Educators and Research, Kolkata |
| Address |
Department of Neonatology, Institute of Post Graduate Medical Education and Research, 244 A. J. C. Bose Road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
8697700890 |
| Fax |
|
| Email |
ratansarmistha2011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post Graduate Medical Education and Research, 244 A. J. C. Bose Road, Kolkata, 700020, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
IPGME&R and SSKM Hospital |
| Address |
244, A.J.C. Bose Road, Kolkata 700020 |
| 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 Madhurima Ganguly |
Institute of Post Graduate Medical Education and Research |
Department of Neonatology, Institute of Post Graduate Medical Education and Research, 244 A. J. C. Bose Road, Kolkata, 700020
Kolkata
WEST BENGAL |
8584054234
madhuganguly22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R research oversight 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 |
High CPAP |
CPAP with PEEP more than 8 cm of H2O will be given till the baby recovers or switched to other non-invasive or invasive mode of ventilation with a duration of maximum 72 hours |
| Comparator Agent |
Synchronised NIPPV |
NIPPV synchronised to patient breath will be given till the baby recovers or switched to other non-invasive or invasive mode of ventilation with a duration of maximum of 72 hours |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
3.00 Day(s) |
| Gender |
Both |
| Details |
All Intramural Preterm (28 to 34 weeks GA) neonate within 72 hrs of life with respiratory distress |
|
| ExclusionCriteria |
| Details |
Major Congenital anomalies
Suspected Chromosomal anomalies
Requirement of Vasopressor/ mechanical ventilation/ hemodynamically unstable at the time of randomisation
Severe Perinatal asphyxia
Upper airway anomalies
Outborn neonates
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Requirement of intubation within 72 hrs of assigned mode/ use of alternative mode of non invasive support |
Requirement of intubation within 72 hrs of assigned mode/ use of alternative mode of non invasive support |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of respiratory support |
At 4 weeks |
| Requirement of intravenous fluid before reaching full feeds |
At 2 weeks |
| Incidence of feed intolerance |
At 4 weeks |
| Incidence of NEC |
At 4 weeks |
| Incidence of pulmonary air leak |
At 4 weeks |
| Incidence of IVH |
At 4 weeks |
| Incidence of culture positive sepsis |
At 4 weeks |
| Incidence of BPD |
At 4 weeks |
| Incidence of hsPDA requiring treatment |
At 4 weeks |
| Incidence of ROP |
At 4 weeks |
| Length of NICU stay |
At 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
03/11/2024 |
| 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 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
|
This study is a randomized controlled trial comparing the clinical efficacy of two non-invasive ventilation methods—Synchronized Nasal Intermittent Positive Pressure Ventilation (NIPPV) and High Continuous Positive Airway Pressure (CPAP)—in preterm neonates (28-34 weeks). The trial aims to determine which method is more effective as the primary mode of respiratory support for neonates experiencing respiratory distress. Key objectives include: - Primary Objective: Assess the need for intubation within 72 hours of starting the assigned mode.
- Secondary Objectives: Examine other clinical outcomes such as the duration of respiratory support, feeding tolerance, the occurrence of necrotizing enterocolitis (NEC), pulmonary air leaks, and length of stay in the neonatal intensive care unit (NICU).
The study will be conducted at IPGMER & SSKM Hospital in Kolkata and will involve 108 participants, randomly assigned to one of the two groups. |