An interventional study of HFOV and HFOV+VG in Respiratory Distress Syndrome (& [Hyaline Membrane Disease]) and Bronchopulmonary Dysplasia (BPD), sponsored by Xingwang Zhu. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Xingwang Zhu · Not applicable, Interventional, and Treatment
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).
25 studies on the registry are indexed under Hyaline Membrane Disease; 10 are open to participants now.
This study's planned enrollment of 348 is above the median of 160 across 14 interventional studies indexed under Hyaline Membrane Disease.
Browse Hyaline Membrane Disease studies →Xingwang Zhu is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Compared within Hyaline Membrane Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Respiratory Distress Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Device: HFOV
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.
Device: HFOV+VG
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
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
Composite outcome of grade 2-3 BPD or in-hospital death at 36 weeks' PMA
Time frame: 36 weeks gestational age
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
The duration of hospitalization
Time frame: through study completion, an average of 1 year
Weight gain (g/kg/day)
Time frame: through study completion, an average of 1 year
The incidence of discharge against medical advice (DAMA)
Time frame: through study completion, an average of 1 year
No study locations are listed for this record.
Plan to share: Yes — Researchers who wish to use the data may apply by emailing the principal investigator with a comprehensive study protocol. After the primary results of this trial have been published, the full, de-identified dataset will be made available to all participating sites of COVES for secondary analyses.
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Xingwang Zhu