An interventional study of Volume targeted ventilation and Pressure targeted ventilation in Neonatal Respiratory Distress, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 0 Minutes to 1 Minute. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
This is a pilot trial to assess the feasibility of volume Targeted Ventilation in the Delivery Room.
Preterm infants will be randomized to pressure guided or volume targeted ventilation during respiratory support in the delivery room
301 studies on the registry are indexed under Pulmonary Atelectasis; 80 are open to participants now.
This study's enrollment of 52 is below the median of 61 across 222 interventional studies indexed under Pulmonary Atelectasis.
Browse Pulmonary Atelectasis studies →University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Positive pressure ventilation will be provided using a set tidal volume
Procedure: Volume targeted ventilation
Positive pressure ventilation will be provided using a set peak inflation pressure
Procedure: Pressure targeted ventilation
Positive pressure ventilation will be provided using a set tidal volume
Positive pressure ventilation will be provided using a set peak inflation pressure
Percentage of of eligible participants (=infants requiring PPV) who have the intervention performed correctly without protocol deviation (=cross over to control group when randomized to VTV-group)
Percentage of Participants who have received allocated treatment
Time frame: Through study completion (total 18 months)
Number of participants with mortality
Infants who died during NICU admission - all-cause in-hospital
Time frame: up to 6 months of NICU admission
Number of participants with severe brain injury on cranial ultrasound
Severe grade 3 and 4 intraventricular or intraparenchymal hemorrhage according to Papile, periventricular leukomalacia, or ventriculomegaly based on neuroimaging studies (timing and frequency of imaging based on local site practices)
Time frame: up to 6 months of NICU admission
Number of participants with severe retinopathy of prematurity (stage 3 or higher)
Defined in the International Classification of ROP, and/or ROP treated with laser, cryotherapy, or intraocular injection therap
Time frame: up to 6 months of NICU admission
Number of participants with bronchopulmonary dysplasia at 36 weeks corrected age
Defined as receiving any supplemental oxygen or any form of respiratory support (including invasive mechanical ventilation, non-invasive ventilation with continuous positive airway pressure, nasal intermittent positive pressure ventilation, or high-flow nasal canula)
Time frame: At 36 weeks corrected age
Number of participants with Bronchopulmonary dysplasia at 40 weeks corrected age
Defined as receiving any supplemental oxygen or any form of respiratory support (including invasive mechanical ventilation, non-invasive ventilation with continuous positive airway pressure, nasal intermittent positive pressure ventilation, or high-flow nasal canula)
Time frame: At 40 weeks corrected age
Total duration of mechanical ventilation via an endotracheal tube in days
Count of days in were an endotracheal tube was placed and the infant was mechanical ventilation
Time frame: Days during NICU admission (up to 6 months)
Number of participants discharge home on oxygen
Infants being discharged home with oxygen
Time frame: At time of NICU discharge (with 6 moths from birth)
Duration of any respiratory support in days
Defined as invasive mechanical ventilation, non-invasive ventilation with continuous positive airway pressure, nasal intermittent positive pressure ventilation, or non-invasive neural assist ventilation or non-invasive high frequency ventilation, or high-flow nasal cannula) in days
Time frame: Days during NICU admission (up to 6 months)
Duration of supplemental oxygen in days
Count of days in were the infant received supplemental oxygen
Time frame: Days during NICU admission (up to 6 months)
Length of hospital stay in days
Defined as number of days from birth to discharge
Time frame: Number of days from birth to discharge (up to 6 months)
Rate of intubation in the delivery room
Infants who were intubated in the delivery room at birth
Time frame: within 60min after birth
Rate of chest compression in the delivery room
Infants who received chest compression in the delivery room at birth
Time frame: within 60min after birth
Rate of pneumothorax
Diagnosed by chest x-ray or lung ultrasound) and interventions (e.g., needle drainage or chest drain)
Time frame: up to 6 months of NICU admission
Number of participants with necrotizing enterocolitis
Defined as modified Bell's criteria stage 2 or greater
Time frame: up to 6 months of NICU admission
Duration of positive pressure ventilation at birth in days
Infants who received positive pressure ventilation in the delivery room at birth
Time frame: within the first 10 min after birth
Resuscitators subjective workload performing mask ventilation
Es evaluated by Surgery Task Load Index (SURG-TLX)-questionnaire.
Time frame: within the first 10 min after birth
Resuscitators qualitative feedback on using VTV-PPV in the delivery room
Provided through free text responses
Time frame: within the first 10 min after birth
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The protocol will be published in an open access journal and data can be requested from the principal investigator
Supporting information: Study protocol, Icf
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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University of Alberta