Health Condition 1: null- Maintenance of thermostability in low birth weight neonates.
Conditions
Interventions
Intervention1: Embrace Infant Warmer: Maintain thermostability in the range of 36.5 to 37.5° C during the treatment phase that lasts for 4 hours as measured by axial or skin probe method.
Control Int
C during the treatment phase that lasts for 4 hours as measured by axial or skin probe method.
Sponsors
Cambree Life Improvement Technologies Pvt Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDR SUDHIR BORGONHA
Director
Outcome results
None listed