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Clinical Trials/NCT02543125
NCT02543125
Unknown
Not Applicable

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

Gao WeiWei0 sites75 target enrollmentFebruary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Insufficiency
Sponsor
Gao WeiWei
Enrollment
75
Primary Endpoint
intubation rate
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
December 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Gao WeiWei
Responsible Party
Sponsor Investigator
Principal Investigator

Gao WeiWei

professor

Guangdong Women and Children Hospital

Eligibility Criteria

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 -

Outcomes

Primary Outcomes

intubation rate

Time Frame: 72 hours

endotracheal intubation rate assessed within 72 hours after extubation

Secondary Outcomes

  • significant apnea(7 days)
  • air leaks(3 months)
  • Bronchopulmonary dysplasia(3 months)
  • necrotizing enterocolitis(3 months)

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