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In very preterm infants with severe respiratory distress syndrome(RDS), invasive ventilation(IV) , besides nasal continuous positive airway pressure (NCPAP) and early/selective pulmonary surfactant administration, is one key cornerstone to reduce neonatal mortality. However, IV is related to increased risks of bronchopulmonary dysplasia (BPD) and abnormal developmental outcomes in the survival.Weaning from IV is therefore a key procedure to reducing these risks above, and if extubation does not success, repeated intubation and/or prolonged duration of IV will result in increased medical burden and intubation-associated complications and death. How to minimize the need for endotracheal ventilation and subsequent complications constitutes a challenge for neonatologists.
Early weaning from invasive ventilation and avoiding re-intubation remains a focus. Nowadays, early use of noninvasive respiratory support strategies has been suggested to be the most effective pathway to reduce those risks. NCPAP is a widely used way of noninvasive ventilation strategies in preterm infants. However, there is only 60% success rate in avoiding intubation. Supplying with the combined advantages of HFOV and NCPAP with high CO2 removal, no need for synchronisation, less volume/barotraumas, non-invasion and increased functional residual capacity, nasal high frequency oscillation ventilation (NHFOV) is considered as a strengthened version of NCPAP. Thus, NHFOV may be more effective as post-extubation respiratory support to avoid re-intubation and subsequent complications/sequelae comparing with NCPAP in preterm infants. To date, NHFOV was used increasingly in neonatal intensive care unit (NICU) around the world due to its convenient operation and no consideration of synchronisation, and several small studies have reported the beneficial effects of NHFOV in preterm infants. However, there were rare randomized controlled studies compared NHFOV with NCPAP as post-extubation respiratory support strategies in preterm infants.
The purpose of the present study was to compare NHFOV with NCPAP as post-extubation respiratory support on the need for endotracheal ventilation and subsequent complications in preterm infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NHFOV | Experimental | NHFOV is used as the supporting mode after extubation |
|
| NCPAP | Active Comparator | NCPAP is used as the supporting mode after extubation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NHFOV | Device | NHFOV is used as the noninvasive mode after extubation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| intubation rate | the baby was re-intubated due to respiratory failure | 3 days |
| total time of hospitalization | the duration of baby in hospital | 100 days |
| bronchopulmonary dysplasia(BPD) | bronchopulmonary dysplasia was diagnosed after extubation BPD was defined according to the National Institutes of Health consensus definition | at 28 days after birth or 36 weeks'gestational age or at discharge |
| Measure | Description | Time Frame |
|---|---|---|
| airleaks | airleaks was diagnosed after extubation | 3 days |
| Retinopathy of prematurity | Retinopathy of prematurity was diagnosed after extubation |
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Inclusion Criteria:
Exclusion Criteria:
Eligibility criteria for extubation:
Besides the improved symptoms, X-rays and sufficient spontaneous breathing efforts, the eligibility criteria for extubation were peak inspiratory pressure (PIP) of 15-20 cm H2O, positive end expiratory pressure (PEEP) of 4-6 cm H2O, respiratory rate of 15 to 30, FiO2 from 0.21 to 0.30, hematocrit more than 35%. and arterialized capillary blood gas analysis need to meet the following criteria: pH>7.20, PaCO2<=55 mmHg.
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| Name | Affiliation | Role |
|---|---|---|
| Shi Yuan, PhD,MD | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Daping Hospital, Third Military Medical University | Chongqing | Chongqing Municipality | 400042 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30955572 | Derived | Chen L, Wang L, Ma J, Feng Z, Li J, Shi Y. Nasal High-Frequency Oscillatory Ventilation in Preterm Infants With Respiratory Distress Syndrome and ARDS After Extubation: A Randomized Controlled Trial. Chest. 2019 Apr;155(4):740-748. doi: 10.1016/j.chest.2019.01.014. |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007752 | Obstetric Labor, Premature |
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| NCPAP |
| Device |
NCPAP is used as the noninvasive mode after extubation |
|
| 100 days |
| Neonatal necrotizing enterocolitis | Neonatal necrotizing enterocolitis was diagnosed after extubation | 3 days |
| Intraventricular hemorrhage | Intraventricular hemorrhage was diagnosed after extubation | 3 days |
| mortality rate | the baby died in hospital | 100 days |
| patent ductus arteriosus (PDA) | patent ductus arteriosus (PDA) was diagnosed | 100 days |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |