Respiratory Distress Syndrome of Newborn
Conditions
Keywords
InSurE, LISA, SNIPPV
Brief summary
This study evaluates the less invasive surfactant administration (LISA) combined with synchronized nasal intermittent positive pressure ventilation (SNIPPV) technique in the treatment of respiratory distress syndrome (RDS) of preterm neonates. The modified InSurE group will receive LISA + SNIPPV technique, while the traditional InSurE group will receive the intubation, surfactant, extubation and CPAP technique.
Interventions
PROCEDURELISA+SNIPPV
The LISA+SNIPPV group receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation.
PROCEDUREtraditional InSurE
The traditional InSurE group receives intubation-surfactant- extubation technique and selects CPAP ventilation.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
Inclusion criteria
1. premature infants with birth weight \< 2500g and gestational age \< 36+6 weeks; 2. High-risk premature infants with early symptoms of RDS or infants who are diagnosed clinically RDS. 3. the participating hospital obtained the consent of the Ethics Committee. 4. parental informed consents were obtained.
Exclusion criteria
1. severe congenital malformations. 2. severe cyanotic congenital heart disease (such as transposition of great artery, tetralogy of Fallot, etc.) which affects systemic hemodynamics. 3. congenital hereditary metabolic diseases. 4. parental informed consent was not obtained.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the average duration of mechanical ventilation | 40 weeks | the average duration of mechanical ventilation of each group |
| the duration of oxygen therapy | 40 weeks | the duration of oxygen therapy of each group |
| the incidence of BPD | 28 days | the incidence of BPD in each group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary Severity Score (PSC) | 1st, 2nd, 3rd, 7th, 14th, 28th days | PSC was defined as FiO2 × support + medications, where FiO2 is the actual or 'effective' (for nasal cannula) FiO2; support is 2.5 for a ventilator, 1.5 for nasal continuous positive airway pressure, or 1.0 for nasal cannula or hood oxygen; and medications is 0.20 for systemic steroids for BPD, 0.10 each for regular diuretics or inhaled steroids, and 0.05 each for methylxanthines or intermittent diuretics. The scores can range from 0.21 to 2.95. |
| the incidence of complications | 40 weeks | the incidence of complications (e.g. necrotizing enterocolitis, cholestasis, retinopathy of prematurity, extrauterine growth retardation) |
| oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2) | the period of oxygen therapy | oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2) |
Countries
China
Outcome results
None listed