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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LISA+SNIPPV group | Experimental | receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation |
|
| InSurE group | Active Comparator | receives intubation-surfactant- extubation technique and selects CPAP ventilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LISA+SNIPPV | Procedure | The LISA+SNIPPV group receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation. |
| Measure | Description | Time Frame |
|---|---|---|
| the average duration of mechanical ventilation | the average duration of mechanical ventilation of each group | 40 weeks |
| the duration of oxygen therapy | the duration of oxygen therapy of each group | 40 weeks |
| the incidence of BPD | the incidence of BPD in each group | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Severity Score (PSC) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoqing Chen, Dr | The First Affiliated Hospital with Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27649091 | Background | Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GH, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update. Neonatology. 2017;111(2):107-125. doi: 10.1159/000448985. Epub 2016 Sep 21. | |
| 25607427 | Background |
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| traditional InSurE | Procedure | The traditional InSurE group receives intubation-surfactant- extubation technique and selects CPAP ventilation. |
|
| 1st, 2nd, 3rd, 7th, 14th, 28th days |
| the incidence of complications | the incidence of complications (e.g. necrotizing enterocolitis, cholestasis, retinopathy of prematurity, extrauterine growth retardation) | 40 weeks |
| oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2) | oxygenation index and ventilation function (PaO2、a/APO2、FiO2、PaCO2) | the period of oxygen therapy |
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| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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