None listed
Conditions
Brief summary
We will investigate whether delivery of positive inflation pressure (PIP) (singly or repeated), triggered by a 3 second pause in respiration, can re-establish breathing efforts in preterm infants on continuous positive airway pressure (CPAP), a form of non-invasive respiratory support. The study will involve infants born at <30 weeks gestation who require CPAP support, and are having episodes of respiratory pauses. We will conduct a 16 hours crossover study comparing the use of a device to generate PIP with standard CPAP support. The study will be in blocks of 4 hours (randomly assigned) in which PIP is delivered singly, repeatedly (up to 3), or not at all (standard CPAP). We hypothesise that PIP will improve the regularity of breathing, and shorten the duration of respiratory pauses.
Interventions
This will be a 16 hour crossover study consisting of 4 periods, each of 4 hours duration. Both the first and second halves of the study will consist of a control and intervention epoch at random. During each intervention epoch, positive inflating pressure (PIP) triggered by 3 seconds of apnoea will be delivered either singly (sPIP) or repetitively (rPIP, up to 3 inflations). The maximum pressure of 18 cmH2O will be delivered via a PIP generating device, coupled to the existing CPAP circuit. A mi
This will be a 16 hour crossover study consisting of 4 periods, each of 4 hours duration. Both the first and second halves of the study will consist of a control and intervention epoch at random. During each intervention epoch, positive inflating pressure (PIP) triggered by 3 seconds of apnoea will be delivered either singly (sPIP) or repetitively (rPIP, up to 3 inflations). The maximum pressure of 18 cmH2O will be delivered via a PIP generating device, coupled to the existing CPAP circuit. A minimum washout period of 15 minutes will occur between each epochs. To monitor fidelity, UTAS researchers will be on-site during intervention period. Additionally, CPAP pressures are measured and recorded throughout the 16 hour study period. Bedside staff are not required to monitor or manage the PIP generator beyond their usual interaction with the normal CPAP circuit.
Sponsors
University of Tasmania
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 4 Months
Healthy volunteers
No
Inclusion criteria
- Birth gestation <30 weeks - Chronological age < /=4 months - Supported with bubble CPAP - Having frequent respiratory pauses 5+ seconds duration, resulting in episodes of hypoxia (SpO2 <85) and/or bradycardia (heart rate <100 bpm) at least twice per hour. - Research team available to commence study - Agreement of treating clinician that the infant is suitable for involvement in the study - Signed parental consent
Exclusion criteria
Change in mode of respiratory support, including use of non-triggered continuous non-invasive positive pressure ventilation (NIPPV) being contemplated in next 24 hours
Outcome results
None listed