AzTrials
AzTrials

Respiratory InsufficiencyNCT02543125

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

A study testing NIPPV and NHFOV in people with Respiratory Insufficiency, run by Gao WeiWei.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 1 hour to 3 months
Conditions the study is for
Respiratory Insufficiency
What is being tested?
NIPPV and NHFOV
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
No sites listed yet
Study dates
Feb 2016to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 hour to 3 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • birth weight>1000g
  • gestational age >28 weeks
  • have respiratory distress syndrome and need invasive ventilation

Who cannot join

  • birth wight<1000g
  • gestational age <28 weeks
  • infants wiht abnormalities of upper and lower airways
  • infants have contraindications of non-invasive ventilation -

About this study

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

Read the 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.

Being tested
NIPPV, NHFOV
Keywords
very low birth weight, respiratory distress, NHFOV, NIPPV
Medical subject headings
Respiratory Insufficiency, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NIPPVDevice

    Also called SLE 5000

    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.

  • NHFOVDevice

    Also called SLE 5000

    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.

Study groups in NCT02543125
Study groupRoleWhat they receive
NIPPVActive comparatorNIPPV 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 .
Receives: Device: NIPPV
NHFOVActive comparatorNHFOV 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.
Receives: Device: NHFOV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. intubation rate

    endotracheal intubation rate assessed within 72 hours after extubation

    Measured: 72 hours

Secondary outcomes (4)

  1. significant apnea

    significant apnea measured by Colin J definition:6 episodes requiring stimulation in 6 hours or requiring > 1episodes of positive ventilation

    Measured: 7 days

  2. air leaks

    air leaks assessed by chest X-ray

    Measured: 3 months

  3. Bronchopulmonary dysplasia

    Bronchopulmonary dysplasia assessed by national institute of child health and human development definition

    Measured: 3 months

  4. necrotizing enterocolitis

    necrotizing enterocolitis assessed by abdominal X-ray and Bell classification

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completionAug 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02543125
Sponsor's protocol ID
guangdongwchhi4
Status last verified
Feb 2016
First submitted
21 Aug 2015
Last updated
24 Feb 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • 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.

    PubMed 16632652

  • 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.

    PubMed 9797628

  • 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.

    PubMed 18549418

  • 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.

    PubMed 20857278

  • 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.

    PubMed 24378898

  • 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.

    PubMed 25227281

Questions about this trial

What is this clinical trial studying?

A study testing NIPPV and NHFOV in people with Respiratory Insufficiency, run by Gao WeiWei.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

intubation rate (time frame: 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02543125, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in