RecruitingACTRN12619000740190

Studies of apnoea in the newborn: Delivery of positive inflating pressure as early rescue

The SANDPIPER study: Delivery of positive inflation pressure as early rescue triggered by respiratory pause in preterm infants <30 weeks gestation on bubble CPAP


Sponsor

University of Tasmania

Enrollment

20 participants

Start Date

Jul 16, 2019

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMax Age: 4 Monthss

Plain Language Summary

Simplified for easier understanding

Premature babies, especially those born before 30 weeks, frequently experience brief pauses in breathing called apnoeas. These episodes can cause the baby's oxygen level to drop and their heart rate to slow, which can be stressful for both the baby and the care team. CPAP (Continuous Positive Airway Pressure) is the standard support used for these babies, but when a breathing pause occurs, nurses or therapists typically need to manually stimulate the baby to restart breathing. This study is testing a device that automatically delivers a short puff of air (called a positive inflation pressure, or PIP) when it detects the baby has stopped breathing for three seconds. The device either gives one puff or up to three puffs. Researchers will compare these approaches to standard CPAP alone in a crossover study — meaning each baby acts as their own control across different four-hour blocks. This study is for very premature babies (born before 30 weeks) who are currently on CPAP and experiencing frequent apnoeic episodes. Babies whose doctors are considering changing their breathing support in the next 24 hours are not eligible. If effective, this device could reduce the number of critical episodes and decrease the need for more invasive breathing support.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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. Duri

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.


Locations(1)

Royal Hobart Hospital - Hobart

TAS, Australia

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ACTRN12619000740190


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