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Feasibility of a low-cost respiratory support device for use in Indian tertiary neonatal unit

Low-cost bubble continuous positive airway pressure (CPAP) in Indian tertiary NICU- A mixed -method feasibility study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053919
Enrollment
50
Registered
2023-06-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P239- Congenital pneumonia, unspecified Health Condition 2: P228- Other respiratory distress of newborn Health Condition 3: P229- Respiratory distress of newborn, unspecified Health Condition 4: P220- Respiratory distress syndrome of newborn Health Condition 5: P221- Transient tachypnea of newborn

Interventions

Intervention1: 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, Massachus

Sponsors

Mysore Medical College and Research Institute
Lead Sponsor
Dr Girish G
Collaborator
Dr Hamsa M
Collaborator
Dr Raj Prakash
Collaborator
Dr Shalini SR
Collaborator
Dr Srinivas BH
Collaborator
Prof Thomas F Burke
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All babies admitted to inborn or out-born neonatal unit needing bubble CPAP as respiratory support will be included for the study.

Exclusion criteria

Exclusion criteria: Babies with severe life-limiting congenital anomalies will be excluded

Design outcomes

Primary

MeasureTime frame
Mortality ( all cause )Timepoint: At discharge—

Secondary

MeasureTime frame
Air leak syndromes - pneumothorax, pneumomediastinum & pneumopericardiumTimepoint: 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)Timepoint: At 36 weeks gestation;Clinical sepsis needing antibiotics.Timepoint: During NICU stay & while on vayu CPAP;Culture positive sepsisTimepoint: During NICU stay & while on vayu CPAP;Duration of CPAP useTimepoint: during NICU stay;Duration of hospital stayTimepoint: At discharge;Intractable ventricular haemorrhageTimepoint: At discharge;Intubation/mechanical ventilationTimepoint: During NICU stay;Nasal injury – skin erosion, ulceration, bleeding, septal injury or scarring.Timepoint: During NICU stay;Necrotising enterocolitisTimepoint: At discharge;Patent ductus arteriosusTimepoint: At discharge;Qualitative data using questionnaire survey to access staff opinion about deviceTimepoint: During study period multiple time;Retinopathy of prematurityTimepoint: At discharge or on follow up;Surfactant therapyTimepoint: During NICU stay—

Countries

India

Contacts

Public ContactDr Shalini S R

Mysore Medical College and Research Institute

drsavithamr@yahoo.com7204533071

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026