| CTRI Number |
CTRI/2026/02/103763 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A trial comparing two breathing support machines for premature babies with lung problems |
|
Scientific Title of Study
|
Heated humidified high flow nasal cannula with individualized flow titration (8–12 l/min) versus nasal cpap as primary respiratory support in preterm neonates of 28–36 weeks’ gestation with respiratory distress syndrome: a pilot randomised 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 |
ABDUL KHADER |
| Designation |
Drnb resident |
| Affiliation |
Ankura hospital for women and children, kukatapally |
| Address |
Department of neonatology, ankuraa hospital for women and children, 3rd floor, kukatpally.
Metro pillar no 788, opp NH 65, bagh ameer, sumitra nagar Colony, kukatpally, hyderabad- 500072, telangana, India
Hyderabad
TELANGANA
500085
India |
| Phone |
8897160257 |
| Fax |
|
| Email |
a.khaderkp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VIRARAGHAVAN VADAKKENCHERRY RAMASWAMY |
| Designation |
Senior Consultant and Head, Department of Neonatology, Ankura Hospital for Women and Children |
| Affiliation |
Ankura hospital for women and children, kukatapally |
| Address |
Metro pillar no 788, opp NH 65, Bagh Ameer, Sumitra Nagar Colony, Kukatpally, Hyderabad 500072,Telangana, India
Hyderabad
TELANGANA
500085
India |
| Phone |
8130402185 |
| Fax |
|
| Email |
19.vira@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ABDUL KHADER |
| Designation |
Drnb resident |
| Affiliation |
Ankura hospital for women and children, kukatapally |
| Address |
Department of neonatology, Ankura hospital for women and children, Metro pillar no 788, opp NH 65, bagh ameer, sumitra nagar Colony, kukatpally, hyderabad- 500072, telangana, India
Hyderabad
TELANGANA
500085
India |
| Phone |
8897160257 |
| Fax |
|
| Email |
a.khaderkp@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ankura hospital for women and children kukatpally |
| Address |
Department of neonatology, NICU 3rd floor, Metro Pillar No 788, Opp NH 65, Bagh Ameer, Sumitra Nagar Colony, Kukatpally, Hyderabad- 500072, Telangana, India |
| 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 |
| Dr ABDUL KHADER |
Ankura Hospital For Women And Children, kukatpally |
Department of neonatology,ankura hospital for women and children, kukatpally, 3rd floor, NICU, Metro pillar no 788, opp NH 65, bagh ameer, sumitra nagar Colony, kukatpally, hyderabad- 500072, telangana, India
Hyderabad
TELANGANA |
08897160257
a.khaderkp@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 |
| Patients |
(1) ICD-10 Condition: P220||Respiratory distress syndrome of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HHHFNC initiated at 8-10 L/min and titrated up to a maximum of 12 L/min based on gestational age strata. |
In the HHHFNC group, flow rate will be initiated as follows:
28 0/7 – 31 6/7 weeks: 8 L/min, 32 0/7 – 36 6/7 weeks: 10 L/min
Flow rate will be increased every 15-20 minutes in increments of 1 L/min, up to a maximum flow of 12 L/min, based on clinical evaluation in all neonates.
HHHFNC would be delivered through a ventilator or blender circuit (Fisher & Paykel Healthcare, Inc., Auckland). We shall use Fisher & Paykel Optiflow Junior 2 nasal cannula as the nasal interface, and the size of cannula will be based on nares diameter, such that the outer prongs: nares diameter will be between 0.4 to 0.6. The following cannulas would be used: XS (blue), S (red), M (yellow), L (green).
In both the groups FiO2 will be titrated to maintain SpO2 between 90 - 94%.
|
| Comparator Agent |
NCPAP initiated at 5 cm H2O and titrated up to a maximum of 7 cm H2O, irrespective of gestational age.
|
In the NCPAP group, NCPAP will be initiated at 5 cm H2O and titrated in steps of 1 cm H2O every 15-20 minutes up to a maximum CPAP level of 7 cm H2O, based on respiratory distress in all the neonates irrespective of gestational age. Bubble CPAP (Fisher & Paykel Healthcare, Inc., Auckland) or ventilator CPAP or a variable flow CPAP device would be used in this group. NCPAP masks of appropriate size will be used as the nasal interface (Neo-mask, Drager, Lubeck, Germany). |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Day(s) |
| Gender |
Both |
| Details |
preterm neonates born at 28 0/7 – 36 6/7 weeks’ gestation
Diagnosed with RDS based on clinical or radiographic criteria and requiring NRS support. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Composite of receipt of surfactant therapy or treatment failure or requirement of invasive mechanical ventilation (IMV) |
within 72 hours of life |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Treatment failure
|
within 72 hours of life |
| Requirement of Invasive Mechanical Ventilation |
within 72 hours of life |
| Receipt of surfactant |
within 72 hours of life |
| Mortality |
until discharge |
| Bronchopulmonary dysplasia (BPD) |
at 36 weeks PMA |
| Mortality or BPD |
until discharge |
Duration of NRS support.
|
until discharge |
Air leak syndromes
|
until discharge |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
23/02/2026 |
| 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="1"
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 is parallel group pilot randomised controlled trial (RCT) which will be conducted from 15th February 2025 until 15th March 2027, in a level 3 NICU centre in Hyderabad, India. Neonates born between 28 0/7 – 36 6/7 weeks’ gestation and meeting the inclusion criteria will be eligible for inclusion after obtaining informed consent from the parent or the caretaker. The protocol has taken the respective Institutional Ethical Committee approval. Enrolled neonates will be randomized into two groups namely, Heated Humidified High Flow Nasal Cannula (HHHFNC) at 8–12 L/min versus nasal CPAP (NCPAP). Baseline characteristics will be recorded after enrolment using a pre-determined structured proforma. The primary outcome will be a composite of receipt of surfactant therapy or treatment failure or requirement of invasive mechanical ventilation (IMV) within 72 hours of life. |