role of non-invasive ventilation in reducing extubation failure in term neonates

Proposal summary

Aim: To study the role of non-invasive ventilation in reducing extubation failures in term neonates

Primary objective: To compare the efficacy of nasal CPAP (CPAP), heated humidified high flow nasal cannula (HFNC) and low flow oxygen (LFO) in reducing extubation failure within 72 hours of extubation in term babies.

Secondary objective: i) to study the profile of term neonates on mechanical ventilation

ii) To study the other secondary outcomes i) need for reintubation, ii) duration of oxygen need, iii) duration of hospital stay and iv) mortality in the three groups

Inclusion criteria: all term babies (gestational age ≥ 37 weeks) on mechanical ventilation when ready for extubation will be included in the study.

Exclusion criteria: i) major congenital malformation ii) genetic syndromes iii) babies who underwent gastrointestinal surgery iv) airway malformations

Term neonates on mechanical ventilation will be randomised when they are ready to be extubated, to receive nasal continuous positive pressure ventilation (CPAP) or heated humidified high flow nasal oxygen (HFNC) or low flow oxygen (LFO) (≤ 1 Lit/m) by prongs immediately after extubation. All babies who were ventilated for ≥ 7 days will be given intravenous dexamethasone in a dose of 0.15 mg/kg/day for 3 doses 8 hours apart starting 2 hours prior to planned extubation. All standard treatment protocols will be followed.  Randomization will be done by a computer software into three groups. The allocated group will be placed in a sequentially numbered opaque sealed envelope and will be opened at the time of enrolment.

Extubation failure will be defined as any one of the following in a neonate on maximum support in each group; i) > 3 episodes of apnea (duration ≥ 20 sec) over a period of 1 hour or any episode of apnea needing positive pressure ventilation ii) Silverman Anderson score > 5 iii) neonate not able to maintain saturation 90-95%. Maximum support will be defined as CPAP pressure of 7 cm H2O in CPAP group or flow rate of 7L/min in HFNC group and on flow rate of 1L/min in the LFO group

All babies having extubation failure on HFNC and LFO group will be started on nasal CPAP as a rescue therapy. CPAP failure in these babies will be defined as mentioned earlier. Babies having extubation failure on CPAP will be intubated and stared on mechanical ventilation.

Sample size: Based on the previous studies a sample size of 35 babies will be taken for each group.

All data will be analysed using Epi info 7.