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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volume Targeted Ventilation | Experimental | Positive pressure ventilation will be provided using a set tidal volume |
|
| Pressure guided Ventilation | Active Comparator | Positive pressure ventilation will be provided using a set peak inflation pressure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volume targeted ventilation | Procedure | Positive pressure ventilation will be provided using a set tidal volume |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion (total 18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with mortality | Infants who died during NICU admission - all-cause in-hospital | up to 6 months of NICU admission |
| Number of participants with severe brain injury on cranial ultrasound |
| Measure | Description | Time Frame |
|---|---|---|
| Resuscitators subjective workload performing mask ventilation | Es evaluated by Surgery Task Load Index (SURG-TLX)-questionnaire. | within the first 10 min after birth |
| Resuscitators qualitative feedback on using VTV-PPV in the delivery room |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Georg Schmölzer, MD, PhD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Alexandra Hospital | Edmonton | Alberta | T5H 3V9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41567425 | Derived | Law BHY, Yaskina M, Davis PG, Polglase G, Dunn M, Mukerji A, Schmolzer GM. Study protocol for the volume targeted mask ventilation versus pressure ventilation in preterm infants-the VOLT-trial. Front Pediatr. 2026 Jan 6;13:1743460. doi: 10.3389/fped.2025.1743460. eCollection 2025. | |
| 38727883 | Derived | Bharadwaj U, Kainth D, Sankar J. Refining Ventilation During Neonatal Resuscitation Using Ventilator: Time for a Well-Designed Clinical Study! Indian J Pediatr. 2024 Oct;91(10):997-998. doi: 10.1007/s12098-024-05154-6. Epub 2024 May 10. No abstract available. |
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The protocol will be published in an open access journal and data can be requested from the principal investigator
Protocol will be published within 18 months
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2025 | Jan 6, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Pressure targeted ventilation | Procedure | Positive pressure ventilation will be provided using a set peak inflation pressure |
|
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)
| 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 | 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) | 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) | 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 | Days during NICU admission (up to 6 months) |
| Number of participants discharge home on oxygen | Infants being discharged home with oxygen | 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 | Days during NICU admission (up to 6 months) |
| Duration of supplemental oxygen in days | Count of days in were the infant received supplemental oxygen | Days during NICU admission (up to 6 months) |
| Length of hospital stay in days | Defined as number of days from birth to discharge | 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 | within 60min after birth |
| Rate of chest compression in the delivery room | Infants who received chest compression in the delivery room at birth | within 60min after birth |
| Rate of pneumothorax | Diagnosed by chest x-ray or lung ultrasound) and interventions (e.g., needle drainage or chest drain) | up to 6 months of NICU admission |
| Number of participants with necrotizing enterocolitis | Defined as modified Bell's criteria stage 2 or greater | 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 | within the first 10 min after birth |
Provided through free text responses
| within the first 10 min after birth |