neonatal acute respiratory distress syndrome
Conditions
Interventions
HFOV group:high-frequency oscillatory ventilation
SIMV+VG group:synchronized intermittent mandatory ventilation with volume guarantee
Sponsors
Xuzhou Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Newborns with gestational age at birth 40 weeks, within 4 weeks after birth; 2. Meet the diagnostic criteria for NARDS [1,2]; must satisfy the following 5 items simultaneously: (1) Time of injury: acute respiratory distress occurs within 1 week after a confirmed or suspected clinical injury; (2) Exclusion of other diseases: exclude primary neonatal respiratory distress syndrome (NRDS), transient tachypnea of the newborn, congenital malformations (including complex congenital heart disease, choanal atresia, cleft palate, tracheoesophageal fistula, pulmonary adenoma-like malformation, pulmonary sequestration, diaphragmatic hernia, and other congenital cardiopulmonary diseases), or respiratory distress caused by surfactant-related genetic defects; (3) Chest X-ray: show bilateral diffuse irregular opacities or infiltrates, even white lungs, which cannot be fully explained by localized effusion, atelectasis, NRDS, transient tachypnea of the newborn, or congenital malformations; (4) Echocardiography: aids in confirming pulmonary edema that cannot be explained by congenital heart disease, or acute pulmonary hemorrhage caused by patent ductus arteriosus with pulmonary over-perfusion; (5) Oxygen index (OI) value [OI = fraction of inspired oxygen x mean airway pressure (cmH2O) x 100 / arterial oxygen partial pressure (mmHg)] >= 4 (mild: 4 = 16). 3. Meet the criteria for mechanical ventilation [3,4]: when on non-invasive positive pressure ventilation, must meet at least one of the following: (1) Hypoxemia, i.e., when FiO2 > 0.4, PaO2 60 mmHg; (3) Frequent apnea, i.e., spontaneous recovery apnea >= 3 times/h, or occurrence of apnea requiring bag-mask positive pressure ventilation once within 24 h, which is not relieved by caffeine treatment.
Exclusion criteria
Exclusion criteria: 1.Meet at least one of the following criteria: Neonates with severe congenital anomalies or chromosomal abnormalities; 2.Already received mechanical ventilation for more than 2 hours; 3.The parents refuse to sign the informed consent form or refuse the use of mechanical ventilation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OI value at 72 hours after enrollment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of mechanical ventilation support;Mean arterial pressure (MAP);Pulmonary artery pressure (PAP);Alveolar-arterial oxygen difference (PA?aO?);Fraction of inspired oxygen;Lung ultrasound score (LUS); | — |
Countries
China
Contacts
Public ContactGao Xiangyu
Xuzhou Central Hospital
Outcome results
None listed