| CTRI Number |
CTRI/2024/09/073484 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of Efficacy of three types of non-invasive respiratory supports after removal of endotracheal tube in preterm & term neonates. |
|
Scientific Title of Study
|
Efficacy of Nasal high frequency oscillatory ventilation (nHFOV) VERSUS Synchronised non-invasive positive pressure ventilation (SNIPPV) VERSUS Nonsynchronised non-invasive positive pressure ventilation (NS-NIPPV) as a post extubation respiratory support in preterm neonates (≥ 28 WEEKS OF GESTATION) admitted in a tertiary care centre – A 3 ARM RANDOMIZED CONTROL 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 |
Sk samim |
| Designation |
DM Resident of Neonatology |
| Affiliation |
IPGMER & SSKM HOSPITAL |
| Address |
Department of Neonatology
IPGMER AND SSKM HOSPITAL
KOLKATA 700020
WEST BENGAL
Kolkata
WEST BENGAL
700020
India |
| Phone |
9002769144 |
| Fax |
|
| Email |
sksamim93@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bijan Saha |
| Designation |
Associate professor |
| Affiliation |
IPGMER & SSKM Hospital |
| Address |
Department of Neonatology
IPGMER AND SSKM Hospital
Kolkata 700020
West Bengal
Kolkata
WEST BENGAL
700020
India |
| Phone |
9051389120 |
| Fax |
|
| Email |
bijansaha18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sk samim |
| Designation |
DM Resident of Neonatology |
| Affiliation |
IPGMER & SSKM HOSPITAL |
| Address |
Department of Neonatology
IPGMER AND SSKM HOSPITAL
KOLKATA 700020
WEST BENGAL
Kolkata
WEST BENGAL
700020
India |
| Phone |
9002769144 |
| Fax |
|
| Email |
sksamim93@yahoo.in |
|
|
Source of Monetary or Material Support
|
| IPGMER AND SSKM Hospital
Kolkata 700020
West Bengal
India
|
|
|
Primary Sponsor
|
| Name |
Neonatology Departmental Fund |
| Address |
Department OF Neonatology
IPGMER & SSKM Hospital
Kolkata 700020
West Bengal
India |
| 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 Sk Samim |
IPGMER & SSKM Hospital Kolkata |
Neonatal Intensive Care Unit
DEPARTMENT OF NEONATOLOGY
IPGMER & SSKM Hospital
Kolkata 700020
West Bengal
Kolkata
WEST BENGAL |
9002769144
sksamim93@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER RESEARCH OVERSIGHT COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J969||Respiratory failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nasal high frequency oscillatory ventilation (nHFOV) |
After randomization Nasal high frequency oscillatory ventilation (nHFOV) will be used for 72 hours after extubation. |
| Comparator Agent |
Nonsynchronised non-invasive positive pressure ventilation (NS-NIPPV) |
After randomization nonsynchronized non-invasive positive pressure ventilation (NS-NIPPV) will be used for 72 hours after extubation. |
| Comparator Agent |
Synchronised non-invasive positive pressure ventilation (SNIPPV) |
After randomization Synchronized non-invasive positive pressure ventilation (SNIPPV) will be used for 72 hours after extubation. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Month(s) |
| Age To |
11.00 Month(s) |
| Gender |
Both |
| Details |
1. Infants born ≥28 weeks of gestation
2. Inborn babies upto postnatal age 15 days
3. Mechanically ventilated for at least 12 hrs.
|
|
| ExclusionCriteria |
| Details |
1. Infant born at less than 28 weeks of
gestational age
2. Outborn babies
3. Major congenital anomalies or suspected
chromosomal anomalies
4. Upper airway malformations
5. Severe perinatal asphyxia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Extubation failure within 72 hours |
Extubation failure within 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Bronchopulmonary dysplasia (BPD)
2. Mortality (all causes within NICU stay/ upto 28
days)
3. Invasive ventilator days
4. Invasive Ventilator free days
5. Necrotizing enterocolitis (Stage 2 and above)35
6. Late onset sepsis (only blood culture proven)
7. Gastrointestinal perforation (confirmed on
roentgenogram or surgical exploration)
8. Pulmonary air leak including pulmonary
interstitial emphysema (PIE),
pneumomediastinum and pneumothorax.
9. Intraventricular haemorrhage on cranial
ultrasound, grade 3 and above
10. Feed intolerance
11. Retinopathy of prematurity (ROP) any stage
|
upto discharge or death |
|
|
Target Sample Size
|
Total Sample Size="129"
Sample Size from India="129"
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)
|
15/09/2024 |
| 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
|
We hypothesize that nHFOV, SNIPPV & NS-NIPPV are equally efficacious as a mode of respiratory support after extubation & reduce the need for endotracheal re-intubation. Comparison of nHFOV with NIPPV is still in its infancy and more studies are required to come to a consensus statement. In this study we have planned to compare nHFOV versus SNIPPV versus NS-NIPPV as a post extubation respiratory mode in preterm neonates more than equal to 28 weeks of gestational age admitted in a tertiary care centre from eastern India which to the best of our knowledge has not been done so far. |