| CTRI Number |
CTRI/2025/12/099711 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO STUDY NEONATES UNDERGOING ENDOTRACHEAL INTUBATION WITH HIGH NASAL FLOW OXYGEN VS STANDARD CARE |
|
Scientific Title of Study
|
A Randomized controlled study of neonates undergoing endotracheal intubation with high nasal flow oxygen VS standard care |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HIMA CHANDANA MANKALA |
| Designation |
STUDENT |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES A BLOCK 5TH FLOOR DEPARTMENT OF PAEDIATRICS
KR ROAD ,PARVATHIPURAM ,VISHVESHWARAPURA , SHANKARAPURA BENGALURU
Bangalore
KARNATAKA
560004
India |
| Phone |
7022712223 |
| Fax |
|
| Email |
chandanahima20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUNIL B |
| Designation |
PROFESSOR OF PAEDIATRICS |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES A BLOCK 5TH FLOOR DEPARTMENT OF PAEDIATRICS
KR ROAD ,PARVATHIPURAM ,VISHVESHWARAPURA , SHANKARAPURA BENGALURU
Bangalore
KARNATAKA
560004
India |
| Phone |
9900485879 |
| Fax |
|
| Email |
docsunilb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUNIL B |
| Designation |
PROFESSOR OF PAEDIATRICS |
| Affiliation |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES |
| Address |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES A BLOCK 5TH FLOOR DEPARTMENT OF PAEDIATRICS
KR ROAD ,PARVATHIPURAM ,VISHVESHWARAPURA , SHANKARAPURA BENGALURU
Bangalore
KARNATAKA
560004
India |
| Phone |
9900485879 |
| Fax |
|
| Email |
docsunilb@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrHima Chandana Mankala |
| Address |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES A BLOCK 5TH FLOOR DEPARTMENT OF PAEDIATRICS
KR ROAD ,PARVATHIPURAM ,VISHVESHWARAPURA , SHANKARAPURA BENGALURU |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrHima Chandana Mankala |
Kempegowda Institute of medical sciences |
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES A BLOCK 5TH FLOOR DEPARTMENT OF PAEDIATRICS
KR ROAD ,PARVATHIPURAM ,VISHVESHWARAPURA , SHANKARAPURA BENGALURU
Bangalore
KARNATAKA |
7022712223
chandanahima20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
no use of oxygen support |
oxygen support is not used here |
| Intervention |
Using high flow nasal oxygen during neonatal endotracheal intubation |
During neonatal endotracheal intubations , randomised cases will be intubated with nigh nasal flow oxygen via nasal prongs |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
all eligible neonates undergoing endotracheal intubation in KIMS NICU |
|
| ExclusionCriteria |
| Details |
infants with oromaxillary and airway anomalies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to observe first successful intubation attempt in neonates undergoing endotracheal intubation with high nasal flow oxygen vs neonates receiving standard care |
to observe first successful intubation attempt in neonates undergoing endotracheal intubation with high nasal flow oxygen vs neonates receiving standard care immediately after the intubation attempt -10 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess if time to desaturation is prolonged with high nasal flow oxygen via nasal prongs |
10 mins of study |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/01/2026 |
| 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="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 aims to evaluate the effectiveness of high-flow nasal oxygen in improving the success of the first endotracheal intubation attempt in neonates, compared with standard care. By closely observing clinical outcomes in both groups, the study seeks to determine whether the continuous oxygen delivery provided by high-flow nasal therapy helps maintain better oxygenation and physiological stability during the procedure. The investigation will assess not only the rate of first-attempt success but also associated factors such as heart rate changes, oxygen desaturation episodes, and overall intubation conditions. Through this comparison, the study intends to generate evidence on whether integrating high-flow nasal oxygen into neonatal airway management can enhance procedural safety and reduce complications during intubation. |