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

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

Plain Language Summary

Simplified for easier understanding

Very premature babies — those born before 28 weeks of pregnancy — often need mechanical ventilation (a breathing machine) in the days after birth because their lungs are not yet mature enough to breathe independently. When doctors feel a baby is ready, they remove the breathing tube — a process called extubation — and switch the baby to a gentler form of breathing support called nasal CPAP, which delivers a constant gentle pressure to keep tiny airways open. However, many babies need to be re-intubated because they cannot manage on their own, which is stressful and carries risks. This study tests whether using a higher CPAP pressure (10 cm of water pressure) when babies are first taken off the ventilator reduces the chances of them needing to go back on it, compared to the standard pressure (around 6-8 cm). Two hundred extremely preterm babies will be randomly assigned to one of the two pressure levels immediately after their first extubation. To be eligible the baby must have been born before 28 weeks gestation, be receiving mechanical ventilation, and be ready for their first extubation attempt. Babies with major congenital abnormalities affecting breathing, or those receiving palliative rather than intensive care, are not eligible. This study is conducted in neonatal intensive care units across multiple hospitals.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 fo

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.


Locations(3)

The Royal Women's Hospital - Parkville

VIC, Australia

Monash Children’s Hospital - Clayton

VIC, Australia

Mater Mother's Hospital - South Brisbane

VIC, Australia

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ACTRN12618001638224


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