Efficacy of heated humidified high-flow nasal cannula (HHHFNC) compared to synchronized nasal intermittent positive pressure ventilation (sNIPPV) as primary respiratory support in late preterm and term infants with respiratory distress requiring non-invasive ventilation within 24 hours after birth. Neonates, non-invasive ventilation, synchronized nasal intermittent positive pressure ventilation, heated humidified high flow nasal cannula, primary respiratory support
Conditions
Interventions
HHHFNC was delivered by OptiflowTM junior nasal high-flow system (Fisher &
Paykel
Healthcare, Auckland, New Zealand), SLE6000 (Inspiration Healthcare Group, Croydon, United
Kingdom), or fabian HFO ventilator (ZOLL Medical Corporation, Massachusetts, United
States). The HHHFN
s condition.
Flow rate was started at 8-10 L/min on the fabian ventilator but was automatically adjusted
on the SLE6000 ventilator. FiO2 was set to keep peripheral oxygen saturation(SpO2) between
90%
Active Comparator Device,Experimental Device
HHHFNC group,sNIPPV group
Sponsors
None listed
Eligibility
Sex/Gender
All
Age
1 Hours to 24 Hours
Inclusion criteria
Inclusion criteria: Late preterm (born between 34 weeks to 36+6/7 weeks) and term neonates (born between 37 weeks to 41+6/7 weeks) who developed respiratory distress within 24 hours after birth and required non-invasive respiratory support.
Exclusion criteria
Exclusion criteria: Infants who had received more than 4 hours of NIV prior to study enrollment, or had major congenital or chromosomal abnormalities, craniofacial anomalies, neuromuscular disorders, congenital lung anomalies, air leak syndrome, or severe cardiovascular instability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment failure rate 72 hours following randomization Silverman Anderson Score, clinical and laboratory parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| Intubation rate 72 hours following randomization Silverman Anderson Score, clinical and laboratory parameters,Time to treatment failure 72 hours following randomization Hour,Duration of respiratory support From start to end of respiratory support Hour,Maximum fraction of inspired oxygen (FiO2) From start to end of respiratory support Maximum FiO2 measured,Time to full feeding From randomization to discharge Days,Nasal injury From randomization to discharge Percentage,Air leak syndrome From randomization to discharge Percentage,Feeding intolerance From randomization to discharge Percentage,CPAP belly From randomization to discharge Percentage,Necrotizing enterocolitis From randomization to discharge Percentage,Length of stay Discharge Days | — |
Countries
Thailand
Contacts
Public ContactPaphawi Leksakundilok
Queen Sirikit National Institute of Child Health
Outcome results
None listed