Respiratory Insufficiency
Conditions
Keywords
very low birth weight, respiratory distress, NHFOV, NIPPV
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.
Interventions
DEVICENIPPV
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.
DEVICENHFOV
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.
Sponsors
Gao WeiWei
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Hours to 3 Months
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intubation rate | 72 hours | endotracheal intubation rate assessed within 72 hours after extubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed