Bronchopulmonary Dysplasia (BPD), Respiratory Distress Syndrome (& [Hyaline Membrane Disease])
Conditions
Brief summary
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
DEVICEHFOV
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
DEVICEHFOV+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 recruitment should be addressed first, rather than overriding the amplitude limit
Sponsors
Xingwang Zhu
Children's Hospital of Chongqing Medical University
The Affiliated Hospital of Inner Mongolia Medical University
The Affiliated Hospital of Jining Medical University and Zaozhuang City
Chongqing Qianjiang Central Hospital
First People's Hospital of Chenzhou
Fujian Children's Hospital
Fuling Hospital of Chongqing University
Guangdong Women and Children Hospital
Henan Children's Hospital Zhengzhou Children's Hospital
Hunan Children's Hospital
Hunan Provincial Maternal and Child Health Care Hospital
Hunan Provincial People's Hospital
Inner Mongolia Maternal and Child Health Care Hospital
Jiangxi Maternal and Child Health Hospital
Kunming Children's Hospital
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
Moscow Regional Research Institute of Obstetrics and Gynecology named after Academician V. I. Krasnopolsky
Northwest Women's and Children's Hospital, Xi'an, Shaanxi
People's Hospital of MeiShan
Quanzhou Women's and Children's Hospital
Qujing Maternal and Child Hospital
Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University
Shanxi Women and Children Hospital
Shenzhen Longhua Maternity and Child Health Care Hospital
Shijiazhuang Obstetrics and and Gynecology Hospital
Third Affiliated Hospital of Guangzhou Medical University
Women and Children's Hospital of Chongqing Medical University
Women and Children's Hospital of Ningbo University
Zhangzhou Affiliated Hospital of Fujian Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite outcome of grade 2-3 BPD or in-hospital death at 36 weeks' PMA | 36 weeks gestational age |
Secondary
| Measure | 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 | 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 |
Contacts
CONTACTYuan Shi, PhD
Outcome results
None listed