| CTRI Number |
CTRI/2024/10/074939 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two modes of oxygen delivery systems (nasal high frequency oscillation ventilation and nasal continuous positive airway pressure) in premature babies who have immature lung. |
|
Scientific Title of Study
|
Nasal high frequency oscillation ventilation versus Nasal continuous positive airway pressure as primary respiratory support in preterm neonates of more than 30weeks gestation with Respiratory distress syndrome: an Open labelled 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 |
Padamata Likhitha |
| Designation |
DrNB Neonatology resident |
| Affiliation |
Ankura hospital for women and children |
| Address |
NICU, 3rd floor, Ankura Hospital for Women and Children, Metro pillar number 788, opposite NH65, Bagh Ameer, Sumitranagar Colony, Kukatpally, Hyderabad, 500072
NICU, 3rd floor, Ankura Hospital for Women and Children, Metro pillar number 788, opposite NH65, Bagh Ameer, Sumitranagar Colony, Kukatpally, Hyderabad, 500072
Hyderabad
TELANGANA
500072
India |
| Phone |
9676303665 |
| Fax |
|
| Email |
likhithaverma2904@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Padamata Likhitha |
| Designation |
DrNB Neonatology resident |
| Affiliation |
Ankura hospital for women and children |
| Address |
NICU, 3rd floor, Ankura Hospital for Women and Children, Metro pillar number 788, opposite NH65, Bagh Ameer, Sumitranagar Colony, Kukatpally, Hyderabad, 500072
NICU, 3rd floor, Ankura Hospital for Women and Children, Metro pillar number 788, opposite NH65, Bagh Ameer, Sumitranagar Colony, Kukatpally, Hyderabad, 500072
Hyderabad
TELANGANA
500072
India |
| Phone |
9676303665 |
| Fax |
|
| Email |
likhithaverma2904@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Padamata Likhitha |
| Designation |
DrNB Neonatology resident |
| Affiliation |
Ankura hospital for women and children |
| Address |
NICU, 3rd floor, Ankura Hospital for Women and Children, Metro pillar number 788, opposite NH65, Bagh Ameer, Sumitranagar Colony, Kukatpally, Hyderabad, 500072
NICU, 3rd floor, Ankura Hospital for Women and Children, Metro pillar number 788, opposite NH65, Bagh Ameer, Sumitranagar Colony, Kukatpally, Hyderabad, 500072
Hyderabad
TELANGANA
500072
India |
| Phone |
9676303665 |
| Fax |
|
| Email |
likhithaverma2904@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ankura Hospital for Women and Children, NICU, 3rd floor, Metro pillar number 788, opposite NH65, Bagh Ameer, Sumitranagar Colony, Kukatpally, Hyderabad, 500072 |
|
|
Primary Sponsor
|
| Name |
Padamata Likhitha |
| Address |
NICU, 3rd floor, Ankura Hospital for Women and Children, Metro pillar number 788, opposite NH65, Bagh Ameer, Sumitranagar Colony, Kukatpally, Hyderabad, 500072 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Padamata Likhitha |
Ankura hospital for women and children |
NICU, 3rd floor, Ankura Hospital for Women and Children, Metro pillar number 788, opposite NH65, Bagh Ameer, Sumitranagar Colony, Kukatpally, Hyderabad, 500072
Hyderabad
TELANGANA |
9676303665
likhitha11814@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ankura Ethics committee- Biomedical research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
preterm neonates with respiratory distress syndrome requiring respiratory support
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nasal CPAP in a preterm more than 30 weeks gestation with respiratory distress syndrome |
Nasal continuous positive airway pressure ventilation will be initiated in a baby diagnosed with respiratory distress syndrome after randomization
|
| Intervention |
nasal HFOV in a preterm neonate more than 30 weeks gestation with respiratory distress syndrome |
Nasal High Frequency oscillation ventilation will be initiated in a baby diagnosed with respiratory distress syndrome after randomization
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
preterm neonates of gestational age 30-36+6/7 weeks diagnosed with respiratory distress syndrome |
|
| ExclusionCriteria |
| Details |
neonates who had undergone endotracheal intubation or had received surfactant prior to randomization , neonates with gross congenital anomalies
whose caretakers refuse to give consent to participate in study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Treatment failure Defined as requirement of an use of an alternative NRS modality NIPPV or BiPAP,
Requirement of IMV within 72 hours of postnatal age
|
Treatment failure Defined as requirement of an use of an alternative NRS modality NIPPV or BiPAP,
Requirement of IMV within 72 hours of postnatal age
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Requirement of surfactant replacement therapy, Pneumothorax, Mortality or BPD (defined as oxygen requirement at 28 days of postnatal age), Mortality, BPD (defined as oxygen requirement at 28 days of postnatal age), Duration of NRS support, Duration of IMV support, Duration of both NRS and IMV support, Duration of hospital stay, Severe intraventricular hemorrhage, Necrotizing enterocolitis stage 2 or more as per modified Bell’s staging, Retinopathy of prematurity (ROP) requiring intervention, Nasal injury |
respiratory support started within 6hours |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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 3 |
|
Date of First Enrollment (India)
|
10/10/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 will be conducted in a level 3 NICU in neonates born more than 30 weeks gestation, meeting the inclusion criteria. After attaining the consent, the neonate will be enrolled, assigned to respective groups after stratified randomization. Baseline characteristics will be recorded at enrolment. Treatment failure and need for IMV at 72 HOL will be observed as primary outcome. |