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An observational study of the gas flow delivered by bubble continuous positive airway pressure (CPAP) to preterm infants in neonatal intensive care

An observational study of the gas flow delivered by bubble CPAP to preterm infants in neonatal intensive care

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619000197134
Enrollment
44
Registered
2019-02-12
Start date
2019-03-29
Completion date
2019-09-10
Last updated
2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a single-centre observational study that aims to measure the gas flow delivered by bubble CPAP to preterm infants in neonatal intensive care. The project will aim to recruit 50 stable infants currently receiving bubble CPAP in the Royal Women’s Hospital Neonatal Intensive Care Unit. The data collection process involves: recording of the gas flow and pressure of the bubble CPAP apparatus at baseline; decreasing the gas flow until bubbling ceases whilst maintaining the CPAP pressure to record the gas flow being delivered to the infant; recording the gas flow with the infant’s mouth closed; after which the gas flow will be returned to its initial setting. This information will provide insight into the mechanism of action of bubble CPAP compared to other non-invasive respiratory supports such as Nasal High-flow Therapy (nHFT). We hypothesise that the gas flow produced in bubble CPAP is similar to that used in nHFT.

Interventions

Preterm infants receiving bubble CPAP in the neonatal intensive care unit will have demographic information and weight recorded. The current state of the infant including flow rate, bCPAP pressure, mouth opening, and nasal prong fit will be recorded. The gas flow will then be adjusted until bubbling just ceases and the flow and pressure measurements will be repeated. The infant’s chin will then be gently supported to close the mouth, and the measurements taken for a third time. This will be

Preterm infants receiving bubble CPAP in the neonatal intensive care unit will have demographic information and weight recorded. The current state of the infant including flow rate, bCPAP pressure, mouth opening, and nasal prong fit will be recorded. The gas flow will then be adjusted until bubbling just ceases and the flow and pressure measurements will be repeated. The infant’s chin will then be gently supported to close the mouth, and the measurements taken for a third time. This will be recorded for 50 infants over the space of 3 months. It will take approximately 15 minutes to record each neonate.

Sponsors

Department of Newborn Research, The Royal Women's Hospital Melbourne
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
No minimum to 6 Months
Healthy volunteers
No

Inclusion criteria

- Infants born less than 37 weeks gestation. - Currently receiving bubble CPAP therapy for any reason in the neonatal intensive care unit (NICU). - Agreement from the treating clinician to include the infant in the study. - Informed consent for participation in the study provided by the parent or guardian.

Exclusion criteria

- Informed consent refused or withdrawn by a parent or guardian. - Unstable clinical condition, including but not limited to respiratory distress and varying oxygen saturation. - Deemed unsuitable by the treating clinician for participation in the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 17, 2026