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| ID | Type | Description | Link |
|---|---|---|---|
| CSTB2024NSCQ-MSX0158 | Other Identifier | Natural Science Foundation of Chongqing |
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| Name | Class |
|---|---|
| Children's Hospital of Chongqing Medical University | OTHER |
| Jiulongpo No.1 People's Hospital | OTHER |
| Chongqing Maternal and Child Health Hospital | OTHER |
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Bronchopulmonary dysplasia (BPD) is a complex disorder and remains the most common complication in very preterm infants. Its incidence is increased with gestational age from 95.5% among infants born at 22 weeks' gestation to 22.2% among those born at 29 weeks' gestation. BPD is associated with the increased risks of delayed neurodevelopment and pulmonary impairment. High incidences of BPD and morbidities indicate inadequacy of current management guidelines of BPD.3 Caffeine reduces the development of BPD by lowering the duration of intubation.4 How to further reduce the risk of BPD and the duration of invasive ventilation remain the key focus for neonatologists.
Before 2017, the management guideline of pediatric and adult acute respiratory distress syndrome (ARDS) exclude perinatal triggers-induced ARDS. Moreover, there is insufficient evidence to recommend high-frequency oscillatory ventilation (HFOV) or conventional mechanical ventilation (CMV) as the preferred fist-line therapy in pediatric and adult ARDS. In contrast, HFOV may benefit preterm baboons with acute pulmonary dysfunction-typically due to respiratory distress syndrome (RDS)-by using low tidal volume, supra-physiologically higher respiratory rate, and lower peak inspiratory pressure to enhance oxygenation and gas exchange. The team also reported that use of HFOV is associated with a modest reduction referring to BPD. However, European consensus guideline of RDS only recommend HFOV being a reasonable alternative to CMV when high pressure is needed to achieve adequate lung inflation. Because randomized controlled trials in humans have yielded inconsistent findings.
These differences between animal models-where RDS was induced and treated with surfactant alone-and clinical scenarios, where preterm birth often involved complex etiologies requiring both surfactant and antibiotics for placental insufficiency or intrauterine infection, may be the diagnosis of RDS and ARDS or the mixture of RDS and ARDS. Such findings highlighted the lack of robust evidence for optimizing ventilation strategies in preterm infants born <32 weeks with perinatal ARDS, and the need for well-designed multi-center randomized controlled trials in this high-risk population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high frenquency oscillation ventilation (HFOV) | Experimental | HFOV + volume guarantee (VG) as the intervention group HFOV was provided only with piston or membrane oscillators capable of delivering true oscillatory pressure with an active expiratory phase (i.e., Acutronic FABIAN-III, SLE 5000, Löwenstein Med LEONI+, or Sensormedics 3100A). Other machines offering high frequency ventilation were excluded. The lung recruitment maneuver was performed as previously described,15 and lung volume was assessed by chest radiography or lung ultrasound, targeting the right diaphragm at the level of 8th-9th rib (or 7th-8th rib in case of air leak). Crossover between HFOV and CMV This study allowed infants who failed to respond to their assigned ventilation mode to receive a trial of the alternate mode. Crossover criteria for HFOV-assigned neonates included failure for 3 hours to maintain SpO2 ≥ 50% despite FiO2 of 1.0, PaCO2 > 60 mmHg for 3 hours, or signs of ventilator-induced cardiac output reduction. Non-responders to HFOV were switched to CMV. |
|
| conventional mechanical ventilation (CMV) | Active Comparator | CMV was delivered by time-cycled, pressure-limited ventilators. Only pressure regulated volume control (PRVC) will be provided by any type of neonatal ventilator. Crossover criteria for CMV-assigned neonates included failure for 3 hours to maintain SpO2 ≥ 50% despite FiO2 of 1.0, PaCO2 > 60 mmHg for 3 hours, or requiring > 30 cm H2O PIP to sustain ventilation. Non-responders to CMV were switched to HFOV. in both groups, ventilator settings were adjusted at the discretion of the attending clinician to maintain a SpO2 between 90%-94%, a PaO2 between 50 and 80 mm Hg and a PaCO2 between 35 and 60 mm Hg and a pH between 7.20 and 7.45. PO2 and PCO2 levels were monitored using arterial blood gas analysis and/or transcutaneous monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFOV | Device | HFOV + volume guarantee (VG) as the intervention group HFOV was provided only with piston or membrane oscillators capable of delivering true oscillatory pressure with an active expiratory phase (i.e., Acutronic FABIAN-III, SLE 5000, Löwenstein Med LEONI+, or Sensormedics 3100A). Other machines offering high frequency ventilation were excluded. The lung recruitment maneuver was performed as previously described, and lung volume was assessed by chest radiography or lung ultrasound, targeting the right diaphragm at the level of 8th-9th rib (or 7th-8th rib in case of air leak). Crossover between HFOV and CMV This study allowed infants who failed to respond to their assigned ventilation mode to receive a trial of the alternate mode. Crossover criteria for HFOV-assigned neonates included failure for 3 hours to maintain SpO2 ≥ 50% despite FiO2 of 1.0, PaCO2 > 60 mmHg for 3 hours, or signs of ventilator-induced cardiac output reduction. Non-responders to HFOV were switched to CMV. |
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of bronchopulmonary dysplasia(BPD) | BPD is defined according to the 2019 diagnostic criteria. For infants discharged before 36 weeks' GA, BPD severity was assessed based on respiratory support at the time of discharge. Infants receiving no supplemental respiratory support were divided into no BPD, those treated with nasal cannula (≤ 2 L/min) as grade 1 BPD, those treated with nasal cannula (> 2 L/min) or noninvasive positive airway pressure as grade 2 BPD and those treated with invasive mechanical ventilation as grade 3 BPD. | 36 weeks' gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| duration of invasive ventilation | duration of invasive ventilation for HFOV or CMV | 36 weeks' gestational age |
| mortality | the included neonates were diagnosed with death |
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Inclusion criteria
Exclusion criteria
Neonates were not included if any of the following criteria were met:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400042 | China |
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| The First Affiliated Hospital of Anhui Medical University |
| OTHER |
| Children's Hospital of The Capital Institute of Pediatrics | OTHER |
| Peking University Third Hospital | OTHER |
| First Hospital of Tsinghua University | OTHER |
| Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital | OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| Quanzhou Children's Hospital | OTHER |
| Xiamen Maternity & Child Care Hospital | OTHER |
| Zhujiang Hospital | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| Guangdong Academy of Medical Science and General Hospital | OTHER |
| Guangdong Women and Children Hospital | OTHER |
| Women and Children's Health Hospital of Yulin | OTHER |
| Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region | OTHER |
| Second Affiliated Hospital of Guangzhou Medical University | OTHER |
| Guiyang Maternal and Child Health Care Hospital | OTHER |
| The First People's Hospital of Zunyi | OTHER |
| Lanzhou University Second Hospital | OTHER |
| Gansu Provincial Maternal and Child Health Care Hospital | OTHER |
| LanZhou University | OTHER |
| First Affiliated Hospital of Harbin Medical University | OTHER |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
| Zhengzhou Children's Hospital, China | OTHER |
| Third Affiliated Hospital of Zhengzhou University | OTHER |
| the Maternal and Child Health Hospital of Hainan Province | OTHER |
| Bethune International Peace Hospital | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Children's Hospital of Nanjing Medical University | OTHER |
| The First Hospital of Jilin University | OTHER |
| Children's Hospital of Fudan University | OTHER |
| Maternal and Children's Healthcare Hospital of Taian | OTHER |
| The Second Hospital of Shandong University | OTHER |
| Shanxi Provincial Maternity and Children's Hospital | OTHER |
| Chengdu Women and Children's Center Hospital | OTHER |
| The Affiliated Hospital Of Southwest Medical University | OTHER |
| Affiliated Hospital of Southwest Medical University | OTHER |
| Shenzhen People's Hospital, The Second Medical College of Jinan University | OTHER |
| Tianjin Central Hospital of Gynecology Obstetrics | OTHER |
| People's Hospital of Xinjiang Uygur Autonomous Region | OTHER |
| Kunming Children's Hospital | OTHER |
| The First People's Hospital of Yunnan | OTHER |
| First Affiliated Hospital of Kunming Medical University | OTHER |
| Yan'an Affiliated Hospital of Kunming Medical University | OTHER |
| Women and Children's Health Hospital of Qujing | OTHER |
| The People's Hospital of Dehong Autonomous Prefecture | OTHER |
| The First People's Hospital of Yinchuan | OTHER |
| The Children's Hospital of Zhejiang University School of Medicine | OTHER |
| Women's Hospital School Of Medicine Zhejiang University | OTHER |
| Beijing 302 Hospital | OTHER |
| Hunan Children's Hospital | OTHER_GOV |
| Women and Children Hospital of Qinghai Province | OTHER |
| Jiangxi Province Children's Hospital | OTHER |
| Inner Mongolia People's Hospital | OTHER |
| Mianyang Central Hospital | OTHER |
| People's Liberation Army No.202 Hospital | OTHER |
| Ningbo Women & Children's Hospital | OTHER |
| Shanghai Children's Medical Center | OTHER |
| First Affiliated Hospital of Guangxi Medical University | OTHER |
| Nanjing Medical University | OTHER |
| Xianyang Children's Hospital | OTHER |
| Qinhuangdao Maternal and Child Health Care Hospital | OTHER |
| Xuzhou Children Hospital | OTHER |
Very preterm neonates with perinatal acute respiratory distress syndrome will be randomized and assigned to high frequency oscillation ventilation (HFOV) or conventional mechanical ventilation (CMV)
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The caregivers will not be blinded, and the outcome assessors and data analysts will be blinded to the intervention.
|
| CMV | Device | CMV as the standard group CMV was delivered by time-cycled, pressure-limited ventilators. Only pressure regulated volume control (PRVC) will be provided by any type of neonatal ventilator. Crossover criteria for CMV-assigned neonates included failure for 3 hours to maintain SpO2 ≥ 50% despite FiO2 of 1.0, PaCO2 > 60 mmHg for 3 hours, or requiring > 30 cm H2O PIP to sustain ventilation. Non-responders to CMV were switched to HFOV. Ventilator settings were adjusted at the discretion of the attending clinician to maintain a SpO2 between 90%-94%, a PaO2 between 50 and 80 mm Hg and a PaCO2 between 35 and 60 mm Hg and a pH between 7.20 and 7.45. PO2 and PCO2 levels were monitored using arterial blood gas analysis and/or transcutaneous monitoring in both groups. |
|
| 36 weeks' gestational age or before discharge |
| air leak (pneumothorax and/or pneumomediastinum) occurred | the included neonates were diagnosed with air leak | 36 weeks' gestational age or before discharge |
| the incidence of hemodynamically significant patent ductus arteriosus (hsPDA) | the included neonates were diagnosed with hsPDA. | 36 weeks' gestational age or before discharge |
| the incidence of retinopathy of prematurity(ROP)> 2nd grades | ROP was categorized according to the International Classification of Retinopathy of Prematurity, revised in 2005 | 36 weeks' gestational age or before discharge |
| the incidence of necrotizing enterocolitis(NEC)≥2nd stages | the development of NEC, specifically focusing on cases classified as Bell's stage ≥2, according to the modified Bell's staging criteria for NEC. | 36 weeks' gestational age or before discharge |
| intraventricular hemorrhage(IVH)>2nd grade | IVH with grades 1-4 were defined by Papile et al | 36 weeks' gestational age or before discharge |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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