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Not yet recruiting NCT07377955

Combined Oscillation-Volume guarantEe Study

No phase Interventional Respiratory Distress Syndrome (& [Hyaline Membrane Disease]) Bronchopulmonary Dysplasia (BPD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HFOV, HFOV+VG.
Who it may be relevant to
Registry conditions: Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), Bronchopulmonary Dysplasia (BPD). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Combined Volume Guarantee High-Frequency Oscillatory Ventilation (HFOV-VG) Versus Conventional High-Frequency Oscillatory Ventilation (HFOV) on Grade 2 to 3 Bronchopulmonary Dysplasia (BPD) or Death in Preterm Infants <32 Weeks With Respiratory Distress Syndrome (RDS)

Overview

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).

Interventions

  • Device HFOV
    HFOV: 1) Mean airway pressure (MAP) and FiO2: titrated via oxygenation-guided lung recruitment maneuvers 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
  • Device HFOV+VG
    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

Primary outcome measures

  • Composite outcome of grade 2-3 BPD or in-hospital death at 36 weeks' PMA [Time frame: 36 weeks gestational age]
Secondary outcome measures (12)
  • In-hospital death at 36 weeks' PMA [Time frame: 36 weeks gestational age]
  • The incidence of BPD at 36 weeks' PMA [Time frame: 36 weeks gestational age]
  • The duration of invasive ventilation at the time of the first successful extubation [Time frame: through study completion, an average of 1 year]
  • Surfactant doses [Time frame: through study completion, an average of 1 year]
  • The incidence of normocapnia, hypercapnia, and hypocapnia during the intervention period [Time frame: through study completion, an average of 1 year]
  • Pulmonary hypertension (PH) requiring iNO treatment, including PPHN within 7 days after birth and cPH after 28 days of life [Time frame: through study completion, an average of 1 year]
  • hsPDA (Iowa score ≥6 ) [Time frame: through study completion, an average of 1 year]
  • The incidence of massive pulmonary hemorrhage, pneumothorax, pneumomediastinum, pneumopericardium, and ventilator-associated pneumonia(VAP) [Time frame: through study completion, an average of 1 year]
  • The incidence of Grade III to IV IVH according to Papile 1978 criteria [Time frame: through study completion, an average of 1 year]
  • The incidence of Necrotizing enterocolitis (NEC) > grade II according to Modified Bell's Staging Criteria [Time frame: through study completion, an average of 1 year]
  • The incidence of Culture-proven late-onset sepsis (onset after 72 hours of life) [Time frame: through study completion, an average of 1 year]
  • The incidence of Retinopathy of premature > grade II [Time frame: through study completion, an average of 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07377955 · Combined Oscillation-Volume gu

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗