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To check the new born babies health like blood pressure and heart rate using Nemocare Raksha device

Functionality and safety of Nemocare Raksha device on monitoring of vital parameters in new born babies.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/06/019825
Enrollment
40
Registered
2019-06-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: P84- Other problems with newborn

Interventions

Intervention1: Nil: Nil

Sponsors

NemoCare Wellness P Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.New born babies admitted in ward who require regular monitoring of vitals 2.Weight >1.5 kgs 3.Both gender

Exclusion criteria

Exclusion criteria: 1. Neonates with injuries, deformities or abnormalities that may prevent proper application of the device 2. Neonates with inadequate heart pump function affecting blood circulation caused by identified cardiac or cardiovascular conditions such as septal defects, or congenital heart disease 3. Neonates with mean arterial blood pressure 4. Neonates under sedatives (Eg: Fentanyl, midazolam, etc) 5. New born of parents not willing to give consent 6. Any other reason that in the opinion of the investigator may exclude participation

Design outcomes

Primary

MeasureTime frame
1.To evaluate the functionality of Nemocare Raksha device on 6 hours monitoring of vital parameters (HR, RR, SpO2, Temperature) in new born 2.To evaluate the safety and tolerability of Nemocare device (adverse events and device issues)Timepoint: 6 hours—

Secondary

MeasureTime frame
1.To evaluate the accuracy of Nemocare device on the measurement of vital parameters (HR, RR, SPO2, Temperature)Timepoint: 6 hours—

Countries

India

Contacts

Public ContactDr Alben Sigamani

Mazumdar Shaw Medical Center,Narayana Hrudayalaya

drrajivaggarwal@hotmail.com9980199866

Outcome results

None listed

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