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| Name | Class |
|---|---|
| Children's Hospital of Chongqing Medical University | OTHER |
| The Affiliated Hospital of Inner Mongolia Medical University | OTHER |
| Affiliated Hospital of Jining Medical University | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HFOV | Active Comparator | 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 |
|
| HFOV+VG | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFOV | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite outcome of grade 2-3 BPD or in-hospital death at 36 weeks' PMA | 36 weeks gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital death at 36 weeks' PMA | 36 weeks gestational age | |
| The incidence of BPD at 36 weeks' PMA | 36 weeks gestational age | |
| The duration of invasive ventilation at the time of the first successful extubation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan Shi, PhD | Contact | +86 23 68757731 | shiyuan@hospital.cqmu.edu.cn |
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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.
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D006819 | Hyaline Membrane Disease |
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012127 | Respiratory Distress Syndrome, Newborn |
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| Chongqing Qianjiang Central Hospital | UNKNOWN |
| First People's Hospital of Chenzhou | OTHER |
| Fujian Maternity and Child Health Hospital | OTHER |
| Fuling Hospital of Chongqing University | UNKNOWN |
| Guangdong Women and Children Hospital | OTHER |
| Zhengzhou Children's Hospital, China | OTHER |
| Hunan Children's Hospital | OTHER_GOV |
| Hunan Provincial Maternal and Child Health Care Hospital | OTHER |
| Hunan Provincial People's Hospital | OTHER |
| Inner Mongolia Maternal and Child Health Care Hospital | OTHER |
| Jiangxi Maternal and Child Health Hospital | OTHER |
| Kunming Children's Hospital | OTHER |
| Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region | OTHER |
| Moscow Regional Research Institute of Obstetrics and Gynecology named after Academician V. I. Krasnopolsky | UNKNOWN |
| Northwest Women's and Children's Hospital, Xi'an, Shaanxi | OTHER |
| People's Hospital of MeiShan | UNKNOWN |
| QuanZhou Women and Children's Hospital | OTHER |
| Qujing Maternal and Child Hospital | UNKNOWN |
| Second Affiliated Hospital of Wenzhou Medical University | OTHER |
| Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University | OTHER |
| Shanxi Women and Children Hospital | UNKNOWN |
| Shenzhen Longhua Maternity and Child Health Care Hospital | UNKNOWN |
| Shijiazhuang Obstetrics and Gynecology Hospital | OTHER |
| The Third Affiliated Hospital of Guangzhou Medical University | OTHER |
| Women and Children's Hospital of Ningbo University | UNKNOWN |
| Zhangzhou Affiliated Hospital of Fujian Medical School | UNKNOWN |
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|
| HFOV+VG | Device | 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 |
|
| through study completion, an average of 1 year |
| Surfactant doses | through study completion, an average of 1 year |
| The incidence of normocapnia, hypercapnia, and hypocapnia during the intervention period | 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 | through study completion, an average of 1 year |
| hsPDA (Iowa score ≥6 ) | through study completion, an average of 1 year |
| The incidence of massive pulmonary hemorrhage, pneumothorax, pneumomediastinum, pneumopericardium, and ventilator-associated pneumonia(VAP) | through study completion, an average of 1 year |
| The incidence of Grade III to IV IVH according to Papile 1978 criteria | through study completion, an average of 1 year |
| The incidence of Necrotizing enterocolitis (NEC) > grade II according to Modified Bell's Staging Criteria | through study completion, an average of 1 year |
| The incidence of Culture-proven late-onset sepsis (onset after 72 hours of life) | through study completion, an average of 1 year |
| The incidence of Retinopathy of premature > grade II | through study completion, an average of 1 year |
| The duration of hospitalization | through study completion, an average of 1 year |
| Weight gain (g/kg/day) | through study completion, an average of 1 year |
| The incidence of discharge against medical advice (DAMA) | through study completion, an average of 1 year |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |