A clinical trial to study the effect of a medical device called Embrace Infant Warmer against the currently available method of thermal care in low birth weight neonates.
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Maintenance of thermo stability in low birth weight neonates.
- Registration Number
- CTRI/2011/04/001696
- Lead Sponsor
- Cambree Life Improvement Technologies Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1Parental agreement to participate, as documented on Informed Consent Document
2Participant age of minimum 6 hours at the time of screening.
3Low Birth Weight neonates ( weight more than or equal to 1500 grams to less than 1999 grams at time of screening)
4Neonate body temperature not less than 36 oC
5Neonate gestated for minimum 32 weeks.
Exclusion Criteria
1Malformation that adversely affects the temperature of the neonate
2Parental refusal to participate.
3Body temperature below 36 oC
4Cardio respiratory distress
5External supply of oxygen or intravenous fluids.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method