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A clinical trial to evaluate the use of TempWatch Device in managemant of hypothermia in new born babies.

A prospective open label randomised controlled trial to evaluate the contribution and usefulness of test device (Temp watch) in management of hypothermia in Low Birth Weight (LBW) infants in India.

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/12/022475
Enrollment
400
Registered
2019-12-20
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: P809- Hypothermia of newborn, unspecified

Interventions

Intervention1: TempWatch: The BEMPU TempWatch is a bracelet device that continuously monitors a newbornâ??s temperature for one month. If the newborn is hypothermic, the TempWatch alerts the caregiver

Sponsors

Bempu Health Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. LBW infants ( 1. parents willing to give written informed consent 2. Families residing within 50 km from the hospital (or a distance that is contextually reasonable for a member of the study team to travel to each infantâ??s home once per week). 3. Baby is able to maintain temperature without radiant warmers 4. Baby is haemo-dynamically stable (normal CFT, strong peripheral pulses) 5. Baby accepting breast feeds well 6. Primary illness has resolved 7. Mother should be confident of taking care of the baby at home 8. Parent are reachable on mobile

Exclusion criteria

Exclusion criteria: 1. infants allergic to Investigational Medical Device. 2. Infants readmitted to NICU for serious illness. 3. New-born is not clinically stable 4. Baby is discharged with a condition known to impact its ability to gain weight, such as downâ??s syndrome, metabolic or genetic disorders 5. New-borns being referred to higher centers 6. Contact details of parents are not available

Design outcomes

Primary

MeasureTime frame
1. Change in KAP scores at baseline and 30th day in both the groups.Timepoint: 30 days

Secondary

MeasureTime frame
1. Weight gain at 30 days enrolment period measured as difference between end of 30 days and baseline (at birth). 2. Any Increase in KMC hours at the end of study. 3. Number of times alarm beeped in each infant day and night and their demography. Timepoint: 30 days

Countries

India

Contacts

Public ContactSubham Dutta

Bempu Health Pvt. Ltd.

Priyanka@bempu.com9036705000

Outcome results

None listed

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