Health Condition 1: J962- Acute and chronic respiratory failure
Conditions
Interventions
Intervention1: automated oxygen control arm â?? auto-ox: The automated oxygen control follows an â??adaptive controlâ?? algorithm. Once setup, the algorithm adopts the present/current FiO2 as the star
Sponsors
Prithiviraj Kesavan
Eligibility
Inclusion criteria
Inclusion criteria: 1. Neonates who are
Exclusion criteria
Exclusion criteria: 1. Major or life-threatening congenital anomalies 2. Hemodynamic instability requiring vasopressors or inotropes or inhaled nitric oxide 3. Culture proven sepsis or Meningitis within 72 hrs prior to enrollment 4. Refusal of consent by the parents 5. Refusal to include by the treating team due to perceived clinical instability of the neonate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of time (in %) where the SpO2 remained within the target rangeTimepoint: In a 12 hours period from randomisation for intervention A followed by another 12 hours period for intervention B | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare proportion of time (%) spent below the critical saturation level (80%)Timepoint: in 12 hour period;To compare proportion of time (%) spent below the target rangeTimepoint: in 12 hour period;To compare proportion of time(%) spent above the target rangeTimepoint: in 12 hour period;To compare the time to reach within target range (in seconds) when saturation was above the target rangeTimepoint: in 12 hour period;To compare the time to reach within the target range (in seconds) when saturation was below the target rangeTimepoint: in 12 hour period | — |
Countries
India
Contacts
Public ContactVenkataseshan Sundaram
PGIMER
Outcome results
None listed