| CTRI Number |
CTRI/2024/04/066150 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To look for the use of high frequency oscillatory ventilation for reducing the rates of intubation |
|
Scientific Title of Study
|
Noninvasive high frequency oscillatory ventilation versus Noninvasive intermittent positive pressure ventilation as a primary respiratory support in preterms with respiratory distress syndrome- A Randomized Control Trial |
| Trial Acronym |
N I F H T |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonali Amol Avale |
| Designation |
Senior Resident |
| Affiliation |
Government Medical college , Sambhaji Nagar |
| Address |
Department of Neonatology , Government Medical college , Sambhaji Nagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9850584999 |
| Fax |
|
| Email |
sonaliawale1193@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmikant Deshmukh |
| Designation |
Head of Department of Neonatology |
| Affiliation |
Government Medical college , Sambhaji Nagar |
| Address |
Department of Neonatology , Government Medical college , Sambhaji Nagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9822478275 |
| Fax |
|
| Email |
deshmukhls@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmikant Deshmukh |
| Designation |
Head of Department of Neonatology |
| Affiliation |
Government Medical college , Sambhaji Nagar |
| Address |
Department of Neonatology , Government Medical college , Sambhaji Nagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9822478275 |
| Fax |
|
| Email |
deshmukhls@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Medical college , Sambhaji Nagar |
|
|
Primary Sponsor
|
| Name |
Dr Sonali Amol Avale |
| Address |
Department of Neonatology , Government Medical college , Sambhaji Nagar |
| 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 SONALI AMOL AVALE |
DEPARTMENT OF NEONATOLOGY, GOVERNEMENT MEDICAL COLLEGE, AURANGABAD |
DEPARTMENT OF NEONATOLOGY, 2ND FLOOR ,GOVERNEMENT MEDICAL COLLEGE, AURANGABAD
Aurangabad
MAHARASHTRA |
9850584999
sonaliawale1193@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVT. MEDICAL COLLEGE AURANGABAD -431001 |
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 |
| Comparator Agent |
Noninvasive intermittent positive pressure ventilation |
will be initiated in pretrems at initial settings of - PIP -12-14 /FIO2-30%, Rate -40/minute |
| Comparator Agent |
NONINVASIVE INTERMITTENT POSITIVE PRESSURE VENTILATION |
INITIAL SETTINGS-
PIP- 14, PEEP-6 ,RATE-40/MIN FIO2-25-30% WILL BE INITIATED WITHIN 1 HOUR OF LIFE |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
Gestational age (GA) is between 26 and less than 34 weeks. GA will be determined by dates or a dating ultrasound.
If not available- New Ballards score will be used to determine gestational age
Diagnosis of RDS -The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring, and or grunting) within the first 1 hour of life. Chest Xray will be done within 1 hour of life .
Informed parental consent
|
|
| ExclusionCriteria |
| Details |
1.Any baby intubated for resuscitation or for other reasons.
2. Major congenital malformations or known complex congenital heart disease.
3. Refusal to consent |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Need for Invasive Mechanical ventilation in the first 72 hours of life in preterm randomized to the three groups |
first 72 hours of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Days of hospitalization,
2. Days on NIV,
3. Days on supplemental oxygen,
4. Pre-discharge mortality,
5. Surfactant doses,
6. Retinopathy of prematurity,
7. Bronchopulmonary dysplasia ,
8. Abdominal distention, feed intolerance, time to full feed, air leaks
9. Intraventricular hemorrhage ,
10. Spontaneous intestinal perforation,
11. Presence of thick secretions causing an airway obstruction
|
Death
Discharge |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/05/2024 |
| 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
|
Invasive ventilation (IV) is a key procedure to reduce respiratory mortality and morbidity in preterm infants with respiratory distress syndrome (RDS). However, it is associated with the increased risks of bronchopulmonary dysplasia (BPD) ,re-hospitalization, and brain injury among the survivors .Nasal high-frequency oscillatory ventilation (NHFOV) appears to combine the advantages of continuous distending pressure and non-invasive ventilation without need for synchronization and may reduce the incidence of intubation in preterm infants with RDS. A multicentre study has indicated that NHFOV is related to the reducednumbers of apnea, bradycardia, and oxygen desaturation as a remedial measure after failing other noninvasive modes in preterm infants. Hence the purpose of this study is to compare efficacy of noninvasive high frequency ventilation versus non invasive intermittent positive pressure ventilation in preterms with respiratory distress syndrome. |