| CTRI Number |
CTRI/2023/06/053919 [Registered on: 15/06/2023] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Feasibility of a low-cost respiratory support device for use in Indian tertiary neonatal unit |
|
Scientific Title of Study
|
Low-cost bubble continuous positive airway pressure (CPAP) in Indian tertiary NICU- A mixed -method feasibility study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Savitha MR |
| Designation |
Professor and Head of Department |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
Department of Paediatrics, Mysore Medical College and Research Institute, Irwin Road, Mysore, India
Mysore
KARNATAKA
570001
India |
| Phone |
|
| Fax |
|
| Email |
drsavithamr@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Savitha MR |
| Designation |
Professor and Head of Department |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
Department of Paediatrics
Mysore Medical College and Research Institute , Irwin Road, Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
7204533071 |
| Fax |
|
| Email |
drsavithamr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalini S R |
| Designation |
Assistant Professor in Paediatrics |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
DEPARTMENT OF PAEDIATRICS
Mysore Medical College and Research Institute,
Irwin Road,
Mysore,
Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
9483608688 |
| Fax |
|
| Email |
shalinimmcri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neonatal Unit, Cheluvamba Hospital for Women and Children, Mysore Medical College and Research Institute, Mysore, India |
| The Vayu Global Health Foundation,
22 Welgate Road Medford, MA 02155 |
|
|
Primary Sponsor
|
| Name |
Mysore Medical College and Research Institute |
| Address |
Department of Paediatrics, Mysore Medical College and Research Institute, Mysore, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Girish G |
Assistant Professor, Department of Paediatrics, Mysore Medical College and Research Institute, Mysore, India |
| Dr Hamsa M |
Paediatrician, Department of Paediatrics, Mysore Medical College and Research Institute, Mysore, India |
| Dr Raj Prakash |
Paediatrics and Neonatal Speciality Doctor,York and Scarborough Teaching Hospitals NHS Foundation Trust, Wigginton Rd, Clifton, York YO31 8HE |
| Dr Shalini SR |
Assistant Professor, Department of Paediatrics, Mysore Medical College and Research Institute, Mysore, India |
| Dr Srinivas BH |
Senior Resident, Department of Paediatrics, Mysore Medical College and Research Institute, Mysore, India |
| Prof Thomas F Burke |
Professor, Harvard Medical School
Professor, Harvard TH Chan School of Public Health,
Mass General Emergency Medicine
55 Fruit St.
Boston, MA 02115
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Savitha MR |
Mysore Medical College and research institute |
Department of Paediatrics
Inborn and Outborn Neonatal Unit
Irwin Road, next to Railway Station, Mysuru, Karnataka 570001, India
Mysore
KARNATAKA |
7204533071
drsavithamr@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P239||Congenital pneumonia, unspecified, (2) ICD-10 Condition: P228||Other respiratory distress of newborn, (3) ICD-10 Condition: P229||Respiratory distress of newborn, unspecified, (4) ICD-10 Condition: P220||Respiratory distress syndrome of newborn, (5) ICD-10 Condition: P221||Transient tachypnea of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low cost bubble continuous positive airway pressure device (vayu CPAP device) |
The novel low-cost vayu bubble CPAP device developed by vayu global health innovations, Boston, Massachusetts integrating unique air/oxygen venturi blender, bubble humidifier and low resistance breathing circuit.
This nasal CPAP will be used as indicated for newborn babies. The device will be used till it is clinically required on babies and stopped when no respiratory support is needed. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
All babies admitted to inborn or out-born neonatal unit needing bubble CPAP as respiratory support will be included for the study. |
|
| ExclusionCriteria |
| Details |
Babies with severe life-limiting congenital anomalies will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality ( all cause ) |
At discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of CPAP use |
during NICU stay |
| Intubation/mechanical ventilation |
During NICU stay |
| Surfactant therapy |
During NICU stay |
| Nasal injury – skin erosion, ulceration, bleeding, septal injury or scarring. |
During NICU stay |
| Air leak syndromes - pneumothorax, pneumomediastinum & pneumopericardium |
During NICU stay & while on vayu CPAP |
| Duration of hospital stay |
At discharge |
| Culture positive sepsis |
During NICU stay & while on vayu CPAP |
| Clinical sepsis needing antibiotics. |
During NICU stay & while on vayu CPAP |
| Chronic lung disease of prematurity– oxygen or respiratory support at 36 weeks (for less than 32 weeks infants) |
At 36 weeks gestation |
| Retinopathy of prematurity |
At discharge or on follow up |
| Necrotising enterocolitis |
At discharge |
| Intractable ventricular haemorrhage |
At discharge |
| Patent ductus arteriosus |
At discharge |
| Qualitative data using questionnaire survey to access staff opinion about device |
During study period multiple time |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
17/06/2023 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study will be conducted at the NICU of Mysore Medical College and Research Institute in India. Before commencing the study, approval will be obtained from the MMCRI Institutional Ethics Committee. The research will focus on newborns experiencing respiratory distress, and the intervention involves using a low-cost bubble CPAP device. The inclusion criteria encompass all inborn and out-born newborns, including term and preterm infants, requiring respiratory support with bubble CPAP. Various indications for bubble CPAP are outlined, such as respiratory distress, preterm infants with RDS, and apnea of prematurity, among others. Newborns with severe life-limiting congenital anomalies will be excluded from the study. The research will take place in the tertiary NICU of MMCRI, which consists of separate inborn and out-born neonatal units. Standard unit guidelines will be followed, including infection prevention measures, continuous monitoring of vital signs, intravenous fluids, early initiation of enteral feeds, and appropriate antibiotic use. Caffeine will be administered to preterm infants on respiratory support, and those who fail CPAP will be intubated and ventilated. Training on assembling and using the device will be provided to the staff, and a survey will be conducted to assess the device’s ease of use and staff perception. Data will be collected using a pro-forma and a questionnaire-based survey, and both quantitative and qualitative analyses will be conducted. The study will use a convenient sample size, and an internal safety monitoring committee will regularly assess the data. The primary outcome will be mortality, and secondary outcomes include the duration of CPAP use, intubation/mechanical ventilation, surfactant therapy, nasal injury, air leak syndromes, hospital duration, culture-positive sepsis, clinical sepsis, chronic lung disease of prematurity, ROP/NEC/IVH/PDA, and parental consent will be obtained for all babies enrolled in the study. The estimated duration of the study though initially planned for 6 months, later extended to a further 6 months. |