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 thermostability in low birth weight neonates.
- Registration Number
- CTRI/2010/091/001176
- 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
- 20
Inclusion Criteria
1.Clinically stable neonates (not on external oxygen supply, not on IV fluids, and vital signs within the normal limit. Vital signs involve the measurement of the respiratory rate, heart rate and CRT)
2. 1500 grams to 2500 grams at time of screening
3.Gestation period greater than 32 weeks.
4.Signed and dated Informed Consent Document
Exclusion Criteria
1.External supply of oxygen or intravenous fluids
2.Malformation that adversely affects the temperature of the neonate
3.Parental refusal to participate
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ability of the Embrace Infant Warmer to support neonatal thermostability within the range of 36.5oC to 37.5oC.Timepoint: During the study ?treatment phase?, lasting for 4 hours, as determined by axillary or skin probe temperature reading.
- Secondary Outcome Measures
Name Time Method Compare the mean temperature of neonates in the study group and control group (receiving standard care)Timepoint: During the study treatment phase, that lasts for 4 hours, and determined by axillary or skin probe temperature reading.;Efficacy of the Embrace infant warmer in maintaining temperature of the neonate within the range of 36.5oC to 37.5oCTimepoint: During the "study treatment phase", that lasts for 4 hours, and determined by axillary or skin probe temperature reading.;Maintain the temperature of the micro-environment in the Embrace Infant Warmer.Timepoint: During the "study treatment phase" that lasts for 4 hours.;Verify the sterility of the Embrace Infant Warmer when being used for multiple neonatesTimepoint: Compared to the device used in the standard of care arm before use in a neonate and immediately post removal of the neonate form the device