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

Gao WeiWei

Status: Unknown

Conditions: Respiratory Insufficiency

Treatments: Device: NHFOV; Device: NIPPV

Study type: Interventional

Funder types: Other

Identifiers

NCT02543125

guangdongwchhi4

Details and patient eligibility

About

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

Full description

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 1 hour to 3 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. birth weight>1000g
2. gestational age >28 weeks
3. have respiratory distress syndrome and need invasive ventilation

Exclusion criteria

1. birth wight<1000g
2. gestational age <28 weeks
3. infants wiht abnormalities of upper and lower airways
4. infants have contraindications of non-invasive ventilation -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

NIPPV

Active Comparator group

Description:

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 .

Treatment:

Device: NIPPV

NHFOV

Active Comparator group

Description:

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.

Treatment:

Device: NHFOV