Combined Oscillation-Volume guarantEe Study

Xingwang Zhu

Status: Not yet enrolling

Conditions: Bronchopulmonary Dysplasia (BPD); Respiratory Distress Syndrome (& [Hyaline Membrane Disease])

Treatments: Device: HFOV+VG; Device: HFOV

Study type: Interventional

Funder types: Other

Identifiers

NCT07377955

Combined Oscillation-Volume gu

Details and patient eligibility

About

Respiratory Distress Syndrome (RDS) remains the most common respiratory complication in the early postnatal period among preterm infants born before 32 weeks' gestational age. For this population, implementing lung-protective ventilation strategies is essential to shorten the duration of intubation, reduce the incidence and severity of bronchopulmonary dysplasia (BPD), lower mortality, and improve overall outcomes.

HFOV-VG was first reported in 2015 to be safely applied in neonates. The fundamental principle lies in its ability to stabilize the tidal volume of high-frequency ventilation (VThf), thereby reducing sheer stress from amplitude fluctuations, while simultaneously permitting lower VThf settings to minimize volutrauma.

This study aims to evaluate whether HFOV+VG is superior to HFOV in reducing the composite outcome of grade 2-3 BPD or death at 36 weeks' post-menstrual age (PMA).

Enrollment: 348 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age 24+0/7< 320/7 weeks
• Diagnosis of RDS within 72 hours after birth, requiring endotracheal ventilation for both elective and rescue HFOV

Exclusion criteria

• Severe birth defects: severe congenital heart disease, diaphragmatic hernia, gastrointestinal malformations, congenital brain developmental abnormalities, congenital pulmonary cysts
• Uncorrected shock
• Existence of grade 3-4 IVH before ventilated
• Other conditions deemed unsuitable for enrollment by neonatologists, including endotracheal intubation performed specifically for the purpose of the INSURE or INRECSURE technique.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

348 participants in 2 patient groups

HFOV

Active Comparator group

Description:

HFOV: 1) Mean airway pressure (MAP) and FiO2: titrated via oxygenation-guided lung recruitment maneuvers21-23 to maintain preductal SpO2 target of 89%-94%. 2) Frequency: 12-15 Hz for birth weight (BW)\<1500g, and 10-12 Hz for BW≥ 1500g. 3) I:E ratio: 1:1 or 1:2 according to recommendations of manufacturers and local habits

Treatment:

Device: HFOV

HFOV+VG

Active Comparator group

Description:

HFOV-VG Group: ①VThf: \<1000g 1.5-1.8ml/kg, 1000-1500g 1.8-2.2ml/kg, \>1500g, 2.2-2.5ml/kg; ②Amplitude automatically adjusted by volume guarantee algorithm and the upper limit was set at 15% above the measured value after achieving the target VThf, with the constraint that it must not exceed 20 cm H2O for BW\<1000g, 25cm H2O for BW 1000-1500g or 25-30 cmH2O for BW\>1500g; ③If the target VThf is not achieved after the amplitude has reached its upper limit, airway issues (e.g., suctioning) or lung recruitment should be addressed first, rather than overriding the amplitude limit.

Treatment:

Device: HFOV+VG