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HIgh frequency ventilation with VOlume Guarantee in preterm infants (Hi-VOG Trial)

HIgh frequency ventilation with VOlume Guarantee in preterm infants (Hi-VOG Trial) - Hi-VOG trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57834
Enrollment
40
Registered
2025-04-24
Start date
2026-04-16
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

automatic regulation of peak pressure during high frequency ventilation Invasive ventilation in preterm infants

Interventions

When postnatal consent is retrieved from the legal gardians as soon as possible&nbsp
after birth and the preterm infant fails non-invasive respiratory support the&nbsp
patient will be endotracheally intubated following local existing respiratory&nbsp
protocols. Next, HFV will be initiated and after on-line randomisation the&nbsp
patient will be ventilated used our current protocol with HFV without VG or&nbsp
when randomized to the intervention with HFV with VG with VG set between 1-3&nbsp
ml/kg resulting in normal (Tc)PCO2.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - preterm born between 24 weeks 0 days and 29 weeks 6 days post menstrual age - failng non-invasive respiratory support and needs endotracheal intubation for  invasive support - The infant has a parent or other legally acceptable representative capable of  understanding the informed consent document and can provide consent on the  participant behalf.

Exclusion criteria

Exclusion criteria: - The infant has known congenital malformations - The infant is born after a pregnancy with premature rupture of membranes < 22  weeks with anhydramnion or fetal hydrops - Refusal of informed consent - The infant does not have a guardian who can provide informed consent

Design outcomes

Primary

MeasureTime frame
- Incidence of bronchopulmonary dysplasia defined as respiratory support and oxygen need at 36 weeks gestation age in preterm infants <= 29 weeks of gestation - Carbon dioxide stability defined as percentage of time within the target range CO2 (5-8 kPa)

Secondary

MeasureTime frame
- Changes in pressure or DCO2 during OLV with VG in relation to carbon dioxide - Duration of invasive ventilation - Intracerebral findings at 36 weeks of gestation - Effect of VG during standard of care like endotracheal suctioning or endotracheal surfactant administration.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 1, 2026