search
Back to results

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

Primary Purpose

Respiratory Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
NIPPV
NHFOV
Sponsored by
Gao WeiWei
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring very low birth weight, respiratory distress, NHFOV, NIPPV

Eligibility Criteria

1 Hour - 3 Months (Child)All SexesDoes not accept 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 -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    NIPPV

    NHFOV

    Arm 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 .

    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.

    Outcomes

    Primary Outcome Measures

    intubation rate
    endotracheal intubation rate assessed within 72 hours after extubation

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 21, 2015
    Last Updated
    February 22, 2016
    Sponsor
    Gao WeiWei
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02543125
    Brief Title
    Nasal High Frequency Oscillatory Versus Nasal Intermittent Positive Pressure Ventilation in Neonate After Extubation
    Official Title
    Nasal High Frequency Oscillatory Versus Nasal Intermittent Positive Pressure Ventilation in Neonate After Extubation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2016 (undefined)
    Primary Completion Date
    August 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Gao WeiWei

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Insufficiency
    Keywords
    very low birth weight, respiratory distress, NHFOV, NIPPV

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NIPPV
    Arm Type
    Active Comparator
    Arm 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 .
    Arm Title
    NHFOV
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Device
    Intervention Name(s)
    NIPPV
    Other Intervention Name(s)
    SLE 5000
    Intervention Description
    For infants in the NIPPV-group who "fail"NIPPV (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.
    Intervention Type
    Device
    Intervention Name(s)
    NHFOV
    Other Intervention Name(s)
    SLE 5000
    Intervention Description
    For infants in the NHFOV-group who "fail"NHFOV (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.
    Primary Outcome Measure Information:
    Title
    intubation rate
    Description
    endotracheal intubation rate assessed within 72 hours after extubation
    Time Frame
    72 hours
    Secondary Outcome Measure Information:
    Title
    significant apnea
    Description
    significant apnea measured by Colin J definition:6 episodes requiring stimulation in 6 hours or requiring > 1episodes of positive ventilation
    Time Frame
    7 days
    Title
    air leaks
    Description
    air leaks assessed by chest X-ray
    Time Frame
    3 months
    Title
    Bronchopulmonary dysplasia
    Description
    Bronchopulmonary dysplasia assessed by national institute of child health and human development definition
    Time Frame
    3 months
    Title
    necrotizing enterocolitis
    Description
    necrotizing enterocolitis assessed by abdominal X-ray and Bell classification
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Hour
    Maximum Age & Unit of Time
    3 Months
    Accepts Healthy Volunteers
    No
    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 -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    yang jie, doctor
    Organizational Affiliation
    Guangdong Women and Children Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    16632652
    Citation
    Donn SM, Sinha SK. Minimising ventilator induced lung injury in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2006 May;91(3):F226-30. doi: 10.1136/adc.2005.082271.
    Results Reference
    result
    PubMed Identifier
    9797628
    Citation
    van der Hoeven M, Brouwer E, Blanco CE. Nasal high frequency ventilation in neonates with moderate respiratory insufficiency. Arch Dis Child Fetal Neonatal Ed. 1998 Jul;79(1):F61-3. doi: 10.1136/fn.79.1.f61.
    Results Reference
    result
    PubMed Identifier
    18549418
    Citation
    Colaizy TT, Younis UM, Bell EF, Klein JM. Nasal high-frequency ventilation for premature infants. Acta Paediatr. 2008 Nov;97(11):1518-22. doi: 10.1111/j.1651-2227.2008.00900.x. Epub 2008 Jun 9.
    Results Reference
    result
    PubMed Identifier
    20857278
    Citation
    De Luca D, Carnielli VP, Conti G, Piastra M. Noninvasive high frequency oscillatory ventilation through nasal prongs: bench evaluation of efficacy and mechanics. Intensive Care Med. 2010 Dec;36(12):2094-100. doi: 10.1007/s00134-010-2054-7. Epub 2010 Sep 21.
    Results Reference
    result
    PubMed Identifier
    24378898
    Citation
    Null DM, Alvord J, Leavitt W, Wint A, Dahl MJ, Presson AP, Lane RH, DiGeronimo RJ, Yoder BA, Albertine KH. High-frequency nasal ventilation for 21 d maintains gas exchange with lower respiratory pressures and promotes alveolarization in preterm lambs. Pediatr Res. 2014 Apr;75(4):507-16. doi: 10.1038/pr.2013.254. Epub 2013 Dec 30.
    Results Reference
    result
    PubMed Identifier
    25227281
    Citation
    Fischer HS, Bohlin K, Buhrer C, Schmalisch G, Cremer M, Reiss I, Czernik C. Nasal high-frequency oscillation ventilation in neonates: a survey in five European countries. Eur J Pediatr. 2015 Apr;174(4):465-71. doi: 10.1007/s00431-014-2419-y. Epub 2014 Sep 18.
    Results Reference
    result

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs