Post-extubation Pressures in Preterm Neonates: A CER Study

NCT06552455 | Not Yet Recruiting

• 1 other identifier: 4852
• Study Type: observational
• Target: 1,050
• Locations: 0 countries
• Sites: N/A

Brief Summary

The optimal post-extubation pressure level on non-invasive respiratory support modes - irrespective of the choice of the specific non-invasive mode - that optimizes extubation success and improves clinical outcomes remains unknown. The investigators aim to determine the optimal initial non-invasive pressure support level post-extubation in preterm neonates, in relation to the pre-extubation measured mean airway pressures (Paw). The hypothesis is that use of higher pressures will lead to fewer re-intubations. This will be a prospective comparative effectiveness study across participating tertiary NICUs across Canada. Centres will self-select whether to use Higher or Equal/Lower pressure levels as well as the initial post-extubation mode (NIPPV or CPAP) for the study duration. Only the first eligible extubation will be included for analysis. Eligible patients \<28 weeks' gestational age at birth undergoing an eligible extubation (from a mean airway pressure \</= 13 cmH2O) will be included. The primary outcome will be re-intubation within 7 days. Secondary outcomes will include other neonatal morbidities.

Conditions

Respiratory Distress Syndrome; Bronchopulmonary Dysplasia; Preterm Birth

Keywords

Extubation Failure; Non-invasive respiratory support; Prematurity; Post-extubation pressures

Outcome Measures

Primary Outcomes (1)

• Re-intubation within 7 days post-extubation

  7 days

Secondary Outcomes (10)

• Failure of initial NRS (non-invasive respiratory support) mode

  7 days

• Presence of any 1 or more predefined intubation criteria

  7 days

• Moderate to Severe Bronchopulmonary Dysplasia

  until 36 weeks' postmenstrual age (or discharge if sooner)

• Mortality

  During initial hospitalization (up to a maximum of 60 weeks' postmenstrual age)

• Composite of Mortality OR moderate to severe bronchopulmonary dysplasia

  During initial hospitalization (up to a maximum of 60 weeks' postmenstrual age)

Study Arms (2)

Higher Pressure

Use of initial post-extubation pressures that are 2 cmH2O higher than the pre-extubation measured mean airway pressure (Paw). This can be via either CPAP (continuous positive airway pressure) or NIPPV (nasal intermittent positive pressure ventilation). Higher CPAP: Initial set Paw level on CPAP = Pre-extubation measured Paw level + 2 cmH2O Higher NIPPV: Initial set Paw level on NIPPV = Pre-extubation measured Paw level + 2 cmH2O

Equal/Lower Pressure

Use of initial post-extubation pressures that is equal to/lower than the pre-extubation measured mean airway pressure (Paw). This can be via either CPAP (continuous positive airway pressure) or NIPPV (nasal intermittent positive pressure ventilation). Equal/Lower CPAP: Initial set Paw level on CPAP ≤ Pre-extubation measured Paw level Equal/Lower NIPPV: Initial set Paw level on NIPPV ≤ Pre-extubation measured Paw level

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

As above

You may qualify if:

• Preterm neonates GA \<28 weeks' gestation, admitted to a participating centre who received any duration of mechanical ventilation.

You may not qualify if:

• Major chromosomal/genetic/congenital abnormalities
• Never received invasive mechanical ventilation (IMV)
• Received IMV, but never extubated to non-invasive respiratory support (NRS)
• Transferred to non-participating site while intubated
• Death prior to extubation
• Initial extubation was for withdrawal of care
• Lack of any eligible extubation, eligible defined as ALL of the following: (i) ≥36 continuous hours on IMV; (ii) pre-extubation MAP ≤13 cmH2O; and (iii) on post-extubation NRS for ≥1 hour.

Sponsors & Collaborators

• McMaster Children's Hospital: lead
• McMaster University: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Neonatal Network: collaborator

MeSH Terms

Conditions

Respiratory Distress Syndrome; Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Amit Mukerji, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Johnson, RN

CONTACT

905-521-2100; johnsh30@mcmaster.ca

Amit Mukerji, MD

CONTACT

905-21-2100; mukerji@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Staff Neonatologist

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 14, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share