Health Condition 1: null- Maintenance of thermostability of low-birth-weight neonates in the home setting.
Conditions
Interventions
Intervention1: Rural at home embrace infant warmer: Rural at home embrace infant warmer to maintain thermostability in the range of 36.5 to 37.5 degree celcius that lasts for 11 days as measured by ax
Sponsors
Cambree Life Improvement Technologies Private Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Maintaining thermo-stability (36.5 degree Celsius to 37.5 degree Celsius), by the participating neonate at the end of the study treatment phase, as determined by axillary or skin care method. (D0 to D10) 2. Achievement of thermo-stability (36.5 degree Celsius to 37.5 degree Celsius), by the participating neonate at the end of the study treatment phase, as determined by axillary or skin care method. (D0 to D10) 3. Number of occurrence of adverse events and serious adverse events. (D0 to D10) Timepoint: 1) Day 0 to Day 10 2) Day 0 to Day 10 3) Day 0 to Day 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Neonate comfort in the bag. 2)Ease of use by the neonate attendant/care giver Timepoint: During the hospital follow up phase (D 11) | — |
Countries
India
Contacts
Public ContactDR SUDHIR BORGONHA
Cambree Life Improvement Technologies Private Limited
Outcome results
None listed