Nasal High Frequency Oscillation Ventilation
Conditions
Brief summary
The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in preterm twins infants with respiratory distress syndrome
Detailed description
Invasive ventilation is related to development of adverse pulmonary and nonpulmonary outcomes in ventilated infants. Various modes of noninvasive respiratory support are being increasingly used to minimize the incidence of bronchopulmonary dysplasia (BPD). The aim of this trial to compare the effects of noninvasive high frequency oscillatory ventilation (NHFOV) and nasal continuous positive airway pressure (NCPAP) in preterm twins infants as the primary mode.
Interventions
noninvasive high-frequency ventilation (nHFOV) as a primary mode of ventilation in one of the preterm twins infants with respiratory distress syndrome
nasal continuous positive airway pressure (nCPAP) as a primary mode of ventilation in another of the preterm twins infants with respiratory distress syndrome
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
noninvasive high-frequency ventilation (nHFOV) and nasal continuous positive airway pressure (nCPAP) are used as primary mode of ventilation in preterm twins infants with RDS
Eligibility
Sex/Gender
ALL
Age
30 Minutes to 6 Hours
Healthy volunteers
No
Inclusion criteria
1. Gestational age (GA) is from 26 to 37 weeks; 2. Diagnosis of respiratory distress syndrome. The diagnosis of respiratory distress syndrome will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings; 3. Respiratory distress syndrome Silverman score \>5; 4. Informed parental consent has been obtained.
Exclusion criteria
1. Severe respiratory distress syndrome requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation7; 2. Major congenital malformations or complex congenital heart disease; 3. Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage; 4. Cardiopulmonary arrest needing prolonged resuscitation; 5. transferred out of the neonatal intensive care unit without treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intubation | during the first 7 days after birth | the baby is re-intubated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bronchopulmonary dysplasia(BPD) | at a post-menstrual age of 36 weeks or at discharge | BPD was defined according to the National Institutes of Health consensus definition |
| Bayley Scales of Infant Development | 30 months after birth | scores of Bayley Scales of Infant Development at 2 months old and 2 years old |
Countries
China
Contacts
Primary ContactChen Long, MD
Outcome results
None listed