Nasal High Frequency Oscillatory Versus Nasal Intermittent Positive Pressure Ventilation in Neonate After Extubation

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of nasal high frequency oscillatory ventilation(NHFOV) in preterms with respiratory disease syndrome(RDS) after extubation.

Detailed Description
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To very low birth weight infant(VLBW) with respiratory disease syndrome(RDS) who need mechanical ventilation,early extubation may have more benefits.Early extubation may decrease the ventilation-associated pneumonia(VAP),sepsis and decrease the incidence of severity bronchopulmonary dysplasia(BPD).But often fail attempts at extubation because of apnea,atelectasis,hypercapnia,hypoventilation or other illnesses. High frequency oscillatory ventilation is benefit to lung.Initial ventilation with HFOV in preterm with RDS may reduce the incidence of BPD and improve the neurodevelopment.Compared HFOV with conventional ventilation in preterm infants showed that HFOV had superior lung function when 11 to 14 years age.Whether nasal high frequency oscillatory ventilation(NHFOV) also have those advantages in non-invasive mode? Null D M et al do a experiment on preterm lambs,the result suggest that NHFOV may promotes alveolarization.But there was no clinical trials to prove. The nasal intermittent positive pressure ventilation (NIPPV) group fail definition：1、 Fraction of inspired oxygen (FiO2)>40%、MAP>12 centimeter water column (cm H2O),but arterial oxygen saturation (SaO2)<90%.2、significant abdominal distension.3、PaCO2>60millimeter of mercury(mmHg)or partial pressure of arterial oxygen (PaO2)<45 millimeter of mercury(mmHg).4、severe apnea( definition:>6 episodes requiring stimulation in 6 hours or requiring >1 episodes of positive-pressure ventilation) 5.potential of hydrogen (PH)<7.2 The The NHFOV group fail definition：1、FiO2>40%、MAP>14 mbar,but SaO2<90%.2、significant abdominal distension.3、PaCO2>60millimeter of mercury(mmHg) or PaO2<45millimeter of mercury(mmHg).4、severe apnea 5.PH<7.2.

Official Title
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Nasal High Frequency Oscillatory Versus Nasal Intermittent Positive Pressure Ventilation in Neonate After Extubation

Conditions
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Respiratory Insufficiency

Intervention / Treatment
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* Device: NIPPV
* Device: NHFOV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: birth weight>1000g gestational age >28 weeks have respiratory distress syndrome and need invasive ventilation Exclusion Criteria: birth wight<1000g gestational age <28 weeks infants wiht abnormalities of upper and lower airways infants have contraindications of non-invasive ventilation -

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NIPPV<br>NIPPV is provided via binasal prongs. Ventilator settings:FiO2:21-40%,peak inspiratory pressure( PIP)：12-22cm H2O,positive and expiratory pressure(PEEP):5-7cm H2O,Rate:30-60 per minute to maintain SaO2 at 90-95%,The weaning process is left to the discretion of the attending physician,when FiO2: 25%,mean airway pressure (MAP)<6cm H2O,R:30 per minute . | Device: NIPPV<br>* For infants in the NIPPV-group who failNIPPV (see definition below), need immediate intubation, a invasive Rescue-Treatment may be provided. The decision to attempt Rescue-Treatment, the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician.<br>* Other names: SLE 5000;|
| Active Comparator: NHFOV<br>NHFOV is provided via binasal prongs. Ventilator settings:FiO2:21-40%,MAP：6-14 cm H2O,Hertz(HZ):5-10 to maintain SaO2 at 90-95%,The weaning process is left to the discretion of the attending physician,when FiO2: 25%,mean airway pressure (MAP)<6cm H2O. | Device: NHFOV<br>* For infants in the NHFOV-group who failNHFOV (see definition below), need immediate intubation, a invasive Rescue-Treatment may be provided. The decision to attempt Rescue-Treatment, the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician.<br>* Other names: SLE 5000;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation rate | endotracheal intubation rate assessed within 72 hours after extubation | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| significant apnea | significant apnea measured by Colin J definition:6 episodes requiring stimulation in 6 hours or requiring > 1episodes of positive ventilation | 7 days | 
| air leaks | air leaks assessed by chest X-ray | 3 months | 
| Bronchopulmonary dysplasia | Bronchopulmonary dysplasia assessed by national institute of child health and human development definition | 3 months | 
| necrotizing enterocolitis | necrotizing enterocolitis assessed by abdominal X-ray and Bell classification | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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very low birth weight, respiratory distress, NHFOV, NIPPV