Optimal High CPAP Pressures in Preterm Neonates Post-extubation

NCT ID: NCT05230485

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2024-02-15

Brief Summary

Use of continuous positive airway pressure (CPAP) in preterm neonates has traditionally been limited to between 5-8 cmH2O. In recent years, use of CPAP pressures ≥9 cmH2O is becoming more common in neonates with evolving chronic lung disease, in lieu of other non-invasive modes or invasive mechanical ventilation. A particular knowledge gap in the current literature is the choice of the level of pressure level when using High CPAP as a post-extubation support mode. In this study, we will comparatively evaluate the short-term impact of two different high CPAP pressures when used as a post-extubation support mode in preterm neonates.

Detailed Description

Background: Use of continuous positive airway pressure (CPAP) in preterm neonates has traditionally been limited to between 5-8 cmH2O. In recent years, use of CPAP pressures ≥9 cmH2O is becoming more common in neonates with evolving chronic lung disease, in lieu of other non-invasive modes or invasive mechanical ventilation. However, there are limited data on the effectiveness and safety of this mode.

A particular knowledge gap in the current literature is the choice of the level of pressure level when using High CPAP as a post-extubation support mode. While it could be argued that the initial High CPAP pressure post-extubation should be somewhat higher than the pre-extubation mean airway pressure (Paw), there remain concerns of potential complications as well as uncertainty around degree of leak and resulting effectiveness. On the other hand, a suboptimal post-extubation High CPAP level may lead to atelectasis and contribute towards extubation failure, potentially prolonging invasive ventilation and associated risks. As such, research towards identification of the optimal High CPAP level post-extubation from high invasive ventilation pressures is warranted.

Objective: To comparatively evaluate the short-term impact of two different high CPAP pressures when used as a post-extubation support mode in preterm neonates.

Hypothesis: We hypothesize that babies extubated from invasive mechanical ventilation with a mean Paw between 9-15 cmH2O will demonstrate better physiological and clinical parameters when using High CPAP+2 cmH2O vs equivalent CPAP levels.

Methods: Design - This will be a prospective, single-centre, randomized cross-over study.

Conditions

Preterm Birth; Mechanical Ventilation Complication; Respiratory Distress Syndrome, Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Higher CPAP

CPAP level will be 2 cmH2O higher than pre-extubation measured mean airway pressure

Group Type: EXPERIMENTAL

CPAP level

Intervention Type: OTHER

The level of continuous distending pressure (or positive end-expiratory pressure) chosen on CPAP

Equivalent CPAP

CPAP level will be equal to the pre-extubation measured mean airway pressure

Group Type: ACTIVE_COMPARATOR

CPAP level

Intervention Type: OTHER

The level of continuous distending pressure (or positive end-expiratory pressure) chosen on CPAP

Interventions

CPAP level

The level of continuous distending pressure (or positive end-expiratory pressure) chosen on CPAP

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Gestational age <29 weeks; chronological age >7 days; post-menstrual age <37 weeks; extubation from invasive ventilation with measured mean airway pressure 9-15 cmH2O

Exclusion Criteria

• Any congenital or genetic/chromosomal abnormality

• Minimum Eligible Age: 7 Days
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Amit Mukerji

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amit Mukerji, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

McMaster Children's Hospital

Hamilton, Ontario, Canada

Countries

Canada

Central Contacts

Amit Mukerji, MD

Role: CONTACT

mukerji@mcmaster.ca

905-521-2100 ext. 76486

Other Identifiers

14289

Identifier Type: -

Identifier Source: org_study_id