RecruitingACTRN12618001638224

In extremely preterm infants less than 28 weeks gestation who are receiving invasive mechanical ventilation, does extubation to a higher level of continuous positive airway pressure compared to standard practice prevent deterioration and return to mechanical ventilation.

A multicentre randomised control trial comparing high (9-11 cmH2O) vs. standard (6-8 cmH2O) Continuous Positive Airway Pressures after Extubation in Extremely Preterm Infants to reduce extubation failure.

Sponsor

Anna M Kidman

Enrollment

200 participants

Start Date

Mar 3, 2019

Study Type

Interventional

Conditions

Extreme Prematurity

Summary

Does extubation to a higher CPAP pressure decrease risk of extubation failure following the first extubation attempt within the first 3 weeks of birth compared with CPAP pressure currently used? This study will explore the effects of higher nCPAP pressure versus standard CPAP pressure on the need for re-intubation through a randomised clinical trial. This study will involve 200 extremely preterm infants born less than 28 weeks’ gestation who are being extubated. They will be extubated to either the high group of CPAP (10 cm H2O) compared with a standard practice. The hypothesis is that higher levels of nCPAP will reduce extubation failure in the extreme preterm infant.

Eligibility

Sex: Both males and femalesMax Age: 36 Weekss

Inclusion Criteria4

are born less than 28 weeks’ gestation
are being extubated for the first time from mechanical ventilation to nasal CPAP
have received enteral or intravenous caffeine within 24 hours prior to the planned extubation
have received surfactant

Exclusion Criteria4

Are being extubated to any other mode of non-invasive respiratory support other than CPAP, or to no respiratory support
Have a major congenital anomaly or condition that might have an adverse effect on breathing or ventilation: known upper airway obstruction or major airway abnormality, or major congenital heart disease
Are 36 weeks or greater corrected age at time of extubation
Are not receiving full intensive care after extubation

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Interventions

Infants will be extubated to a set Continuous Positive Airway Pressure (CPAP) level of 10 cm H2O. Whilst receiving CPAP, infants will remain within the set CPAP levels range of 9 cm H2O – 11 cm H2O for at least 24 hours, with changes to the set CPAP levels within this range at the discretion of the treating team. After 24 hours, infants may have their set CPAP level weaned at the discretion of the treating team, but must remain within a set CPAP level range 5 cm H2O – 11 cm H2O for at least 7 days after extubation if receiving CPAP. Infants will be re-intubated if they satisfy extubation failure criteria within 7 days after extubation, defined as: FiO2 requirement >0.20 above the pre-extubation FiO2, Two or more apnoeic episodes within any 24-hour period requiring intermittent positive pressure ventilation, or six or more apneoic events requiring stimulation in any 6-hour period, Respiratory acidosis with pH <7.2 and CO2 >60 mm Hg or urgent intubation for an acute deterioration. The fraction of inspired oxygen will be titrated to keep oxygen saturations in the standard target ranges of the enrolling hospital. Adherence to the study protocol will be monitored both by direct observation by study personnel as well as auditing of the individual medical records.