Optimal High CPAP Pressures in Preterm Neonates Post-extubation

NCT05230485 | Unknown

• 1 other identifier: 14289
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Continuous Positive Airway Pressure; Electrical activity of diaphragm; Continuous distending pressure

Outcome Measures

Primary Outcomes (1)

• Peak Edi

  The peak electrical diaphragmatic activity - a surrogate for work of breathing to generate tidal volume

  60 min following each CPAP level - assessed over 10 min

Secondary Outcomes (11)

• Minimum EDi

  60 min following each CPAP level - assessed over 10 min

• Regional cerebral perfusion

  60 min following each CPAP level - assessed over 10 min

• Pressure level - Ventilator

  60 min following each CPAP level - assessed over 10 min

• Pressure level - Interface

  60 min following each CPAP level - assessed over 10 min

• Work of breathing score

  Over entire duration (70 min) at each CPAP level, assessed every 10 min

Study Arms (2)

Higher CPAP

EXPERIMENTAL

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

Other: CPAP level

Equivalent CPAP

ACTIVE COMPARATOR

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

Other: CPAP level

Interventions

CPAP level OTHER

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

Equivalent CPAP; Higher CPAP

Eligibility Criteria

• Age: 7 Days - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Any congenital or genetic/chromosomal abnormality

Sponsors & Collaborators

• McMaster Children's Hospital: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8S4K1, Canada

Location

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Amit Mukerji, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Mukerji, MD

CONTACT

905-521-2100; mukerji@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 9, 2022
• Study Start: February 15, 2022
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)