A clinical trial to trial to see if a medical device called the RURAL AT HOME EMBRACE INFANT WARMER can help maintain normal body temperature in low-birth-weight neonates, when used at home.
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Maintenance of thermostability of low-birth-weight neonates in the home setting.
- Registration Number
- CTRI/2011/11/002125
- Lead Sponsor
- Cambree Life Improvement Technologies Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
1)Parental agreement to participate, as documented on ICF.
2)Participant age of minimum 6 hours at the time of screening.
3)Low-birth-weight neonates (weight more than or equal to 1500 grams to less than 2500 grams at time of screening)
4)Neonate body temperature not less than 36.0 oC
5)Neonate gestated for minimum 32 weeks.
Exclusion Criteria
1)Malformation that adversely affects the temperature of the neonate
2)Parental refusal to participate.
3)Body temperature below 36.0 oC
4)Cardio respiratory distress
5)External 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