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

Phase 3

Conditions: Health Condition 1: P809- Hypothermia of newborn, unspecified

Registration Number: CTRI/2019/12/022475

Lead Sponsor: Bempu Health Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Other (Terminated)

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.LBW infants ( <2,200g) without congenital anomalies discharged from hospital.

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

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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in KAP scores at baseline and 30th day in both the groups.Timepoint: 30 days

Secondary Outcome Measures

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