| CTRI Number |
CTRI/2024/06/069504 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
22/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Mode of oxygen delivery] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of high flow nasal cannula and standard Oxygen delivery for management of Transient Tachypnea of New born |
|
Scientific Title of Study
|
Efficacy of high flow nasal cannula vs standard Oxygen delivery for management of Transient Tachypnea of New born- A 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 |
Meghana |
| Designation |
Post-graduate trainee |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Kalinga institute of medical sciences, Bhubaneshwar
Khordha ORISSA 751024 India |
| Phone |
06304557367 |
| Fax |
|
| Email |
blmeghana441@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Sushree smita behura |
| Designation |
Assistant professor |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
KIMS, Bhubaneshwar
Khordha ORISSA 751024 India |
| Phone |
9437084476 |
| Fax |
|
| Email |
blmeghana441@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Meghana |
| Designation |
Post-graduate trainee |
| Affiliation |
KALINGA INSTITUTE OF MEDICAL SCIENCES |
| Address |
KIMS, Bhubaneshwar
Khordha ORISSA 751024 India |
| Phone |
06304557367 |
| Fax |
|
| Email |
blmeghana441@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
none |
| Address |
none |
| Type of Sponsor |
Other [no sponsorship] |
|
|
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 |
| meghana |
Kalinga institute of medical sciences |
Paediatric department,Patia, Bhubaneshwar Khordha ORISSA |
06304557367
blmeghana441@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P221||Transient tachypnea of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HFNC in TTNB |
late preterm and term neonates within 6 hours of life having mild respiratory distress under suspicion og TTNB are kept on HHHFNC and compared with those kept on nasal cannula. |
| Comparator Agent |
Oxygen via nasal cannula in TTNB |
late preterm and term neonates developing respiratory distress within 6 hours of life kept on oxygen via nasal prongs |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
2.00 Day(s) |
| Gender |
Both |
| Details |
gestational age ≥ 34 weeks admitted within first 6 hours of life. |
|
| ExclusionCriteria |
| Details |
1)Congenital anomalies incompatible with life.
2)history of thick meconium stained fluid and/or diagnosis of meconium aspiration syndrome
3)antenatal diagnosis of major congenital pulmonary or cardiac anomalies
4)initial CXR/ clinical finding demonstrating air leak
5)Downe score ≥ 6
6)Severe Respiratory distress syndrome |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the duration of oxygen requirement between HFNC and standard oxygen therapy. |
Respiratory distress score at 6, 12 and 24 hours of starting HFNC or standard oxygen therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of Respiratory distress score (Downe’s score) at 6, 12 and 24 hrs of life.
2. To compare need of advanced respiratory support (CPAP/Mechanical ventilation) in both arms.
3. Duration of NICU admission
4. Compare need of upper airway care like frequency of suctioning, nebulization, aerosol therapy in both arms.
|
hospital stay in days
downes score |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
20/07/2024 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publications yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - thesis
- For how long will this data be available start date provided 19-02-2025 and end date provided 19-03-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
· Currently most of the babies with mild to moderate respiratory distress managed with oxygen therapy via nasal cannula. Previous studies demonstrated that just five minutes of respiration using ambient gas with no heating or humidification in ventilated infants resulted in a significant decrease in both pulmonary compliance and conductance. Cool, dry air induces a bronchoconstriction response, increases resistance of airway.High-flow nasal cannula systems are designed with proper gas conditioning such as inline warming and humidification systems of supplied gas. Over last 2 decades there is increasing acceptance of HFNC among neonatal health care provider for management of respiratory distress in neonates.For this study, all cases satisfying inclusion criteria admitted in KIMS, Bhubaneshwar from time period of march 2023-Feb2025 will be considered. Written consent from parents will be obtained after explaining them regarding intervention done. Baseline demographic maternal and neonatal characteristics will be noted.Subjects will be assigned into two arms of study by simple randomisation as per inclusion and exclusion criteria.Newborns randomized to HFNC will be started on a flow rate of 4L/min and FiO2 adjusted to maintain oxygen saturations between 91-95%. Once initiated, the measures will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 8L/min and FiO2 of 60%. The nasal cannula size (0.2 cm or 0.3 cm outer diameter) will determined by the caliber of the subject’s nares).The NC flow will be started either at 0.5-1lit/min (acc. To WHO guidelines). The maximum flow to be titrated upto 4 l/min to attain target saturations 91–95% according to our institutional protocol. The size of nasal cannula will be determined by the caliber of the subject’s nares.Study participants who fail to respond to the assigned respiratory modality to be upgraded to either CPAP or mechanical ventilation based on the severity of RD and neonatologist’s decision.Study subjects follwed up for time required on oxygen support.Statistical Analysis done using collected data.
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