Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants (VOLT)

University of Alberta

Status: Completed

Conditions: Neonatal Respiratory Distress

Treatments: Procedure: Volume targeted ventilation; Procedure: Pressure targeted ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT05144724

Pro00115050

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: All

Ages: Under 1 minute old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Volume Targeted Ventilation

Experimental group

Description:

Positive pressure ventilation will be provided using a set tidal volume

Treatment:

Procedure: Volume targeted ventilation

Pressure guided Ventilation

Active Comparator group

Description:

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

Treatment:

Procedure: Pressure targeted ventilation