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

Not Applicable

• Conditions: Respiratory Insufficiency
• Interventions: Device: NIPPV; Device: NHFOV

• Registration Number: NCT02543125
• Lead Sponsor: Gao WeiWei

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2015-08-21
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-07
• Status Verified: 2016-02
• Study Start: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-24
• Primary Completion: 2016-08
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIPPV	NIPPV	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 .
NHFOV	NHFOV	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.

Primary Outcome Measures

Name	Time	Method
intubation rate	72 hours	endotracheal intubation rate assessed within 72 hours after extubation

Secondary Outcome Measures

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