Influence of closed loop automated control of oxygen (CLACO) on time spent by the infant within the target saturation range, and oxygen requirement in South Indian preterm infants under 34 weeks.

As per International and National clinical guidelines, all preterm babies born under 34 weeks gestation are required to achieve a saturation target of 91- 95% to prevent hyperoxia/hypoxia related complications. Currently, nurses manually adjust oxygen supply to maintain target saturations. However, evidence shows that such manual control of oxygen (MCO) therapy is less successful in achieving precise targeted saturation in these vulnerable infants. Closed loop automated control of oxygen (CLACO) has been proven to achieve significant improvement in time spent by the infant within that targeted saturation range.

This is a prospective crossover study where each baby requiring respiratory support, will spend 8 hours monitored by closed loop automated control of oxygen (Oxygenie, SLE 6000 device) (CLACO arm).

The same babies from the intervention group requiring respiratory support will be crossed over and monitored manually by nurses, using the traditional manual control of oxygen for a period of 8 hours.  (MCO arm).

Aims:

Does automated control of oxygen using a CLACO device in South Indian preterm babies result in increased proportion of time spent within the targeted saturation range compared to manual control of oxygen (MCO)?

 Objectives:

1)    We would like to compare the percentage of time spent by the infantinthree different saturation ranges including the target saturation range between 91 to 95%. This comparison would be between the CLACO group and the MCO group.

**2)**To find out if there is any significant difference in the percentage of oxygen required to maintain target saturation range between the two groups (CLACO vs MCO).