Speed of Lung Inflation During Ventilation of Extremely Preterm Infants
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-7
SponsorMurdoch Childrens Research Institute
About this trial
Babies born extremely preterm (\<28 weeks of pregnancy) require support to breathe. Some babies require help to breathe from a breathing machine (mechanical ventilator). While this keeps babies alive, it may damage their lungs. To reduce this damage, doctors and nurses take particular care to try and provide the gentlest breathing support possible. However, evidence is still required to determine how to best support babies' breathing, whilst preventing lung damage and longer-term lung problems.
This clinical trial aims to compare two ways of adjusting a common setting on the breathing machine. This setting is called the pressure rise time or PRT. The PRT determines how quickly the breathing machine inflates a premature baby's lungs. A short PRT quickly inflates the lungs. A long PRT inflates the lungs more slowly. Previous research suggests that more slowly inflating the baby's lungs may cause less lung damage and still allow oxygen to be delivered to and carbon dioxide to be cleared from the lungs. However, larger studies are required to determine whether this should become the standard treatment.
This study investigates whether inflating the baby's lungs more slowly (long PRT) using the breathing machine is as effective as the PRT setting currently used (short PRT, more quickly inflating the lungs).
The main question it aims to answer is: Does how quickly the breathing machine inflates an extremely preterm baby's lung impact their oxygen levels?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Admitted to participating neonatal intensive care unit
Born between 22+0 to 27+6 weeks' gestation
Current weight ≥400 grams
Receiving synchronised, patient-triggered, volume-targeted (all breaths) conventional mechanical ventilation (Pressure Control-Assist Control + Volume Guarantee [PC-AC+VG] mode on Dräger Babylog VN500/800 ventilators) initiated within 72-hours post birth
Disqualifiers
Major congenital anomaly involving the cardiac, respiratory or gastrointestinal systems, or a known genetic syndrome or diagnosis that might affect respiratory course and outcomes
Severe pulmonary hypoplasia due to anhydramnios or oligohydramnios before 22 weeks in which the neonatal consultant anticipates that pulmonary hypoplasia related respiratory failure will be the major respiratory problem in early postnatal life
Receiving (or expected to receive within the next 12 hours) any other mode of mechanical ventilation including synchronised intermittent mandatory ventilation (SIMV), pressure support ventilation (PSV) or high-frequency oscillatory ventilation
Planned for extubation from mechanical ventilation within the next 12 hours.
Trial design
Design model
Crossover
Treatments tested in this trial
Long PRT
Other interventionPRT (in seconds) set at 75% of inspiratory time (in seconds)
Short PRT
Other interventionPRT (in seconds) set at 33% of inspiratory time (in seconds).
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Long-Short PRT SequenceExperimental treatment 2 interventions
Group B: Short-Long PRT SequenceExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in peripheral oxygen saturation to fraction of inspired oxygen ratio (S/F Ratio) measured each minute during each treatment period (0 minutes to 4 hours)
Time frame
0 minutes then each minute up to 4 hours for each of the Long PRT and Short PRT 4-hour treatment periodsSecondary outcomes
1
Change in pressure rise time (PRT) measured each minute during each treatment period (0 minutes to 4 hours).
Time frame
Measured during each of the Long PRT and Short PRT 4-hour treatment periods.2
Change in mean airway pressure (MAP) measured each minute during each treatment period (0 minutes to 4 hours).
Time frame
Measured during of the Long PRT and Short PRT 4-hour treatment periods.3
Change in positive end expiratory pressure (PEEP) measured each minute during each treatment period (0 minutes to 4 hours).
Time frame
Measured during each of the Long PRT and Short PRT 4-hour treatment periods.4
Change in peak inspiratory pressure (PIP) measured each minute during each treatment period (0 minutes to 4 hours).
Time frame
Measured during each of the Long PRT and Short PRT 4-hour treatment periods.Sponsors and contacts
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Murdoch Childrens Research Institute
Lead sponsor
Mercy Hospital for Women, Australia
Collaborator
Royal Women's Hospital, Melbourne, Australia
Collaborator
Western Health, Australia
Collaborator
Source ClinicalTrials.gov
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