Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants

University of Alberta52 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Neonatal Respiratory Distress

Interventions

Volume targeted ventilationPROCEDURE

Positive pressure ventilation will be provided using a set tidal volume

Pressure targeted ventilationPROCEDURE

Positive pressure ventilation will be provided using a set peak inflation pressure

Eligibility

Sex: ALLMin age: 0 MinutesMax age: 1 Minute

Medical Language ↔ Plain English

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

Locations (1)

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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

Data from ClinicalTrials.gov

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