Neonatal respiratory distress syndrome (NRDS)
Conditions
Interventions
LMA:Use of surfactant through a laryngeal mask
Drug: Porcine alveolar surfactant: 200mg/kg/time.
INSURE:Pulmonary surfactant is used through endotracheal intubation, drug: porcine alveolar surfactant: 200mg/kg/time.
Sponsors
West China Second University Hospital,Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Gestational age between 30 0/7 and 36 6/7 weeks, and/or birth weight >= 1500 g; (2)Age within 48 hours after birth; (3)Use of a noninvasive ventilator for more than 30 minutes; (4)Nasal continuous positive airway pressure (nCPAP), BIPAP, or NIPPV support >= 6 cmH2O, or high-flow nasal cannula support >= 6 L/min; (5)Need for FiO2 >= 0.30 to maintain SpO2 levels between 90% and 94%; (6)Radiological evidence of respiratory distress syndrome (RDS).
Exclusion criteria
Exclusion criteria: (1)History of prior invasive mechanical ventilation; (2)Previous surfactant therapy; (3)Congenital anomalies; (4)Pneumothorax; (5)Requirement for direct invasive ventilation; (6)Transfer from external hospitals; (7)Airway abnormalities; (8)Need for continued endotracheal intubation after the INSURE procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fraction of inspired oxygen ;Peripheral oxygen saturation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of catheterization;Episodes of hypoxemia;Episodes of bradycardia;Episodes of tachycardia;Need for second surfactant dose ;Pneumothorax incidence;Whether stomach contents can be aspirated after surfactant administration; | — |
Countries
China
Contacts
Public ContactHua Wang
West China Second University Hospital, Sichuan University
Outcome results
None listed