FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/05/052333 [Registered on: 08/05/2023] Trial Registered Prospectively
Last Modified On: 25/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   EFFECT OF INVASIVE VS NON INVASIVE MODE OF HUMIDIFICATION. 
Scientific Title of Study   A STUDY TO COMPARE NON-INVASIVE(34°C) AND INVASIVE(37°C) MODE OF HUMIDIFICATION DURING NON-INVASIVE VENTILATION IN TERM NEONATE 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANSHUL MADAAN 
Designation  DrNB Neonatology Resident 
Affiliation  Paramitha Children Hospital 
Address  Department of Neonatology, 3rd floor, Paramitha Children Hospital,Green Hills Colony, Kothapet
Near Victoria Memorial Station, Green Hills Colony, Kothapet, Hyderabad, Telanagana
Hyderabad
TELANGANA
500102
India 
Phone  6280060939  
Fax    
Email  madaan1094anshul@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  ANSHUL MADAAN 
Designation  DrNB Neonatology Resident 
Affiliation  Paramitha Children Hospital 
Address  Department of Neonatology, 3rd floor, Paramitha Children Hospital,Green Hills Colony, Kothapet
Near Victoria Memorial Station, Green Hills Colony, Kothapet, Hyderabad, Telanagana
Hyderabad
TELANGANA
500102
India 
Phone  6280060939  
Fax    
Email  madaan1094anshul@gmail.com  
 
Details of Contact Person
Public Query  
Name  ANSHUL MADAAN 
Designation  DrNB Neonatology Resident 
Affiliation  Paramitha Children Hospital 
Address  Department of Neonatology, 3rd floor, Paramitha Children Hospital,Green Hills Colony, Kothapet
Near Victoria Memorial Station, Green Hills Colony, Kothapet, Hyderabad, Telanagana
Hyderabad
TELANGANA
500102
India 
Phone  6280060939  
Fax    
Email  madaan1094anshul@gmail.com  
 
Source of Monetary or Material Support  
Department of Neonatology, Paramitha Children Hospital, Near Victoria Memorial Metro station, Green Hills Colony, Main Road, Kothapet, Hyderabad.500074 
 
Primary Sponsor  
Name  Dr Srinivas Murki 
Address  Head, Department of Neonatology,Paramitha Children Hospital, Near Victoria Memorial Station, Green Hills Colony, Kothapet, Hyderabad, Telanagana,500074 
Type of Sponsor  Other [Thesis Guide] 
 
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 
Dr Srinivas Murki  Paramitha Children Hospital  Division of Neonatology, 3rd Floor, Department of Pediatrics, Paramitha Children Hospital
Hyderabad
TELANGANA 		 9392470351

srinivasmurki2001@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
ParamithaInstitutionalReviewBoard  Approved 
ParamithaInstitutionalReviewBoard  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  High temperature and high humidity  Respiratory gases will be delivered to baby at 37C and humidity of 44mg/L.  
Intervention  Low temperature and low humidity  Respiratory gases will be delivered at temperature of 34 C and humidity of more than 30mg/L and below 44mg/L 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  30.00 Day(s)
Gender  Both 
Details  Term infants admitted in NICU requiring primary non invasive respiratory support 
 
ExclusionCriteria 
Details  1.Babies with congenital anomalies
2.Syndromic babies
3.Neonates receiving therapeutic hypothermia
4.Neonates in whom primary mode of respiratory support is invasive
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Total duration of respiratory support during admission to the NICU  Till hospital discharged. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Ventilator Associated Pneumonia
2. Humidity and Temperature at nasopharyngeal level (thermohygrometer)
3. Need of Intubation/ NIV failure
4.Duration of Oxygen support
5.Pulmonary Hemorrhage (Blood secretions in ET)
6.Pulmonary Edema (Radiographic changes)
7. Sepsis (Culture positive)
8. Frequency of suctioning
9. Weight gain or loss
 		 till discharge 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   08/05/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   All term infants admitted with respiratory distress and requires non invasive mode of ventilation(either CPAP or HFNC) will be given non invasive mode of humidification which is low temperature(34C) and low humidity(>30mg/L) in the intervention arm and Invasive mode of humidification i.e. high temperature(37C) , high humidity(44mg/L) in control arm. both thiese  modes of humidification are present on all standard humidifier (Fischer and Packel MR 850 i.n this case).  Both modes will supply absolute humidity of >30mg/L and temperature of > 30C which is usual recommendation.  
Close