FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. 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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  thesis

  6. 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.

  7. 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.


 
Close