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.

Not Applicable

Recruiting

• Conditions: Extreme Prematurity; Respiratory Distress Syndrome; Reproductive Health and Childbirth - Complications of newborn; Extubation Failure; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12618001638224
• Lead Sponsor: Anna M Kidman

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-03
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

1. Are being extubated to any other mode of non-invasive respiratory support other than CPAP, or to no respiratory support
2. 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
3. Are 36 weeks or greater corrected age at time of extubation
4. Are not receiving full intensive care after extubation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extubation failure defined as:<br>1. Fraction of inspired oxygen requirement >0.20 above the pre-extubation fraction of inspired oxygen, <br>2. 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, <br>3. Respiratory acidosis with pH <7.2 and CO2 >60 mm Hg <br>4. Urgent intubation for an acute deterioration with the reason for re-intubation documented. [7 days POST extubation. ]