Status:

RECRUITING

Acoustics as a Metric of Airway Pressure in Premature Infants Using Bubble Continuous Positive Airway Pressure

Lead Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborating Sponsors:

Northwestern University

Conditions:

Preterm Infant

Eligibility:

All Genders

28-32 years

Brief Summary

This is an observational, proof-of-concept, feasibility study where 30 preterm infants on bubble CPAP with gestational age \< 32+0 weeks will be recruited from the neonatal intensive care unit (NICU) ...

Detailed Description

Continuous positive airway pressure (CPAP) is an essential, non-invasive therapy for treating various respiratory conditions in the Neonatal Intensive Care Units (NICU). CPAP is an effective treatment...

Eligibility Criteria

Inclusion Criteria:

  • Infants on bCPAP with gestational age < 32+0 weeks
  • Postmenstrual age between 28+0 and 36+6 weeks at the time of the study
  • Postnatal age greater than 168 hours (7 days) at the time of the study
  • On the bubble CPAP device with binasal prongs at the time of the study
  • Receiving bubble CPAP levels of 5 to 7 cm H2O with gas flows between 6L/min and 10L/min at the time of the study

Exclusion Criteria:

  • Infants with known major congenital anomalies
  • Infants with known congenital heart disorders
  • Infants with known neuromuscular disease
  • Infants receiving ventilator-derived CPAP at the time of the study
  • Infants receiving CPAP via a nasal mask interface at the time of the study
  • Infants receiving inotropes, narcotics or sedative agents at the time of the study
  • Infants deemed clinically unstable for the study by the attending neonatologist

Key Trial Info

Start Date :

April 3 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT07060833

Start Date

April 3 2025

End Date

December 1 2026

Last Update

March 30 2026

Active Locations (1)

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1

McGill University Health Center

Montreal, Quebec, Canada, H4A 3J1