Neonatal Respiratory Distress
Conditions
Brief summary
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
Interventions
PROCEDUREVolume targeted ventilation
Positive pressure ventilation will be provided using a set tidal volume
PROCEDUREPressure targeted ventilation
Positive pressure ventilation will be provided using a set peak inflation pressure
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Minutes to 1 Minutes
Healthy volunteers
No
Inclusion criteria
* Born between 23+0/7 to 28+6/7 weeks' gestation * Considered suitable for full resuscitation, i.e., no parental request or antenatal decision to forego resuscitation * Informed parental consent
Exclusion criteria
* Major congenital or chromosomal malformation * Conditions that might have an adverse effect on breathing or ventilation (e.g., high risk for lung hypoplasia, congenital diaphragmatic hernia) * Congenital heart disease requiring intervention in the neonatal period * Hydrops requiring intervention in the neonatal period * Neonatal resuscitation initiated before NICU team arrival * Infants who are born outside of study center and transported to center after delivery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Through study completion (total 18 months) | Percentage of Participants who have received allocated treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with mortality | up to 6 months of NICU admission | Infants who died during NICU admission - all-cause in-hospital |
| Number of participants with severe brain injury on cranial ultrasound | up to 6 months of NICU admission | 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) |
| Number of participants with severe retinopathy of prematurity (stage 3 or higher) | up to 6 months of NICU admission | Defined in the International Classification of ROP, and/or ROP treated with laser, cryotherapy, or intraocular injection therap |
| Number of participants with bronchopulmonary dysplasia at 36 weeks corrected age | 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) |
| Number of participants with Bronchopulmonary dysplasia at 40 weeks corrected age | 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) |
| Total duration of mechanical ventilation via an endotracheal tube in days | Days during NICU admission (up to 6 months) | Count of days in were an endotracheal tube was placed and the infant was mechanical ventilation |
| Number of participants discharge home on oxygen | At time of NICU discharge (with 6 moths from birth) | Infants being discharged home with oxygen |
| Duration of any respiratory support in days | Days during NICU admission (up to 6 months) | 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 |
| Number of participants with necrotizing enterocolitis | up to 6 months of NICU admission | Defined as modified Bell's criteria stage 2 or greater |
| Duration of positive pressure ventilation at birth in days | within the first 10 min after birth | Infants who received positive pressure ventilation in the delivery room at birth |
| Duration of supplemental oxygen in days | Days during NICU admission (up to 6 months) | Count of days in were the infant received supplemental oxygen |
| Length of hospital stay in days | Number of days from birth to discharge (up to 6 months) | Defined as number of days from birth to discharge |
| Rate of intubation in the delivery room | within 60min after birth | Infants who were intubated in the delivery room at birth |
| Rate of chest compression in the delivery room | within 60min after birth | Infants who received chest compression in the delivery room at birth |
| Rate of pneumothorax | up to 6 months of NICU admission | Diagnosed by chest x-ray or lung ultrasound) and interventions (e.g., needle drainage or chest drain) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Resuscitators subjective workload performing mask ventilation | within the first 10 min after birth | Es evaluated by Surgery Task Load Index (SURG-TLX)-questionnaire. |
| Resuscitators qualitative feedback on using VTV-PPV in the delivery room | within the first 10 min after birth | Provided through free text responses |
Countries
Canada
Outcome results
None listed