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Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2

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ClinicalTrials.gov Identifier: NCT02340299
Recruitment Status : Terminated (Slow recruitment)
First Posted : January 16, 2015
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Christoph Czernik, Charite University, Berlin, Germany

Brief Summary:
To investigate whether nasal high frequency oscillation ventilation (nHFOV) immediately after extubation reduces the arterial partial pressure of carbon dioxide (paCO2) at 72 hours after extubation in comparison with nasal continuous positive airway pressure (nCPAP) in very low birth weight infants (VLBWs).

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Device: nHFOV Device: nCPAP Not Applicable

Detailed Description:

Randomized controlled clinical trial comparing nHFOV vs nCPAP immediately after extubation of VLBW infants.

Intervention and treatment protocol as described for the two study arms.

Definition of treatment failure (infant meets at least one criterion):

  • Sustained pCO2 >80 mmHg and pH <7.20 confirmed by arterial or capillary blood gas analysis in spite of optimized non-invasive respiratory support with maximum settings as defined above.
  • Fraction of inspired oxygen (FiO2) >0.6 to maintain peripheral oxygen saturation as measured by pulse oximetry (SpO2) at 90-94% in spite of optimized non-invasive respiratory support with maximum settings as defined above.
  • Reintubation (study patients may be intubated at any time, due to clinical considerations, with or without reaching another criterion of "treatment failure").

Sample size:

Assuming a variability of the paCO2 as previously reported for difficult-to-wean preterm infants in our unit (Czernik C, J Matern Fetal Neonatal Med 2012) and a treatment failure rate of 22% within 72 hours after extubation, we calculated a sample size of 34 patients in each study arm to detect a difference in the paCO2 of 7 mmHg, using a two-sided significance of 0.05 and a power of 0.8.

Randomization:

Sequence generation by an independent statistician and a study nurse. Block randomization using at least two different block sizes. Allocation concealment using sequentially numbered opaque sealed envelopes.

Data monitoring:

By an independent statistician.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nasal High Frequency Oscillation Ventilation Versus Nasal Continuous Positive Airway Pressure to Reduce Post-extubation pCO2 in Very Low Birth Weight Infants: a Randomized Controlled Trial
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017


Arm Intervention/treatment
Experimental: nHFOV

Immediately after extubation, nHFOV is provided via binasal prongs. Ventilator settings: Frequency set at 10 Hz, I:E ratio 33:66, amplitude 20 cm H2O, Pmean 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%.

The weaning process is left to the discretion of the attending physician. Maximum amplitude 30 cm H2O, minimum frequency 9 Hz, maximum Pmean 8 cm H2O.

For infants in the nHFOV-group who "fail" nHFOV (see definition below), but do not need immediate reintubation, a non-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.

Device: nHFOV
Extubation to ventilator-derived nHFOV using binasal prongs

Active Comparator: nCPAP

Immediately after extubation, nCPAP is provided via binasal prongs. Ventilator settings: CPAP level set at 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%.

The weaning process is left to the discretion of the attending physician. Maximum CPAP level 8 cm H2O, maximum flow 8 l/min.

For infants in the nCPAP-group who "fail" nCPAP (see definition below), but do not need immediate reintubation, "Rescue-nHFOV" via binasal prongs may be provided. The decision to attempt "Rescue-nHFOV" and the ventilator settings used are at the discretion of the attending clinician.

Device: nCPAP
Extubation to ventilator-derived nCPAP using binasal prongs




Primary Outcome Measures :
  1. paCO2 at 72 h after extubation [ Time Frame: 64 h to 80 h ]

Secondary Outcome Measures :
  1. pH at 2 h after extubation [ Time Frame: within the first 6 h after extubation ]
  2. paO2 at 2 h after extubation [ Time Frame: within the first 6 h after extubation ]
  3. paCO2 at 2 h after extubation [ Time Frame: within the first 6 h after extubation ]
  4. Base excess at 2 h after extubation [ Time Frame: within the first 6 h after extubation ]
  5. pH at 72 h after extubation [ Time Frame: 64-80 h after extubation ]
  6. paO2 at 72 h after extubation [ Time Frame: 64-80 h after extubation ]
  7. Base excess at 72 h after extubation [ Time Frame: 64-80 h after extubation ]
  8. Successful extubation [ Time Frame: 72 h after extubation ]
    Defined as the number of patients breathing spontaneously in their assigned treatment group for ≥72h without reaching the criterion of "treatment failure"

  9. Treatment failure [ Time Frame: within 7 days after extubation ]
    Defined as the number of patients reaching the criterion of "treatment failure"

  10. Reintubation [ Time Frame: within 7 days after extubation ]
    Defined as the number of patients being reintubated

  11. Highly viscous secretions [ Time Frame: within 72 hours after extubation ]
    Defined as the documented number of episodes of airway obstruction due to highly viscous secretions per patient

  12. Other adverse effects [ Time Frame: until discharge ]
    Incidences of the following adverse effects: Intraventricular hemorrhage III°-IV° (Papile), surgical necrotizing enterocolitis, pneumothorax, pulmonary interstitial emphysema, persistent ductus arteriosus requiring surgical closure, retinopathy of prematurity requiring laser treatment and/or injection of bevacizumab, death or moderate to severe bronchopulmonary dysplasia (Jobe) at 36 weeks' gestational age, periventricular leukomalacia

  13. Duration of respiratory support [ Time Frame: until discharge ]
    Total duration of mechanical ventilation, total duration of supplemental oxygen, number of infants discharged with home oxygen


Other Outcome Measures:
  1. pH at 2 h after switch to "rescue treatment" [ Time Frame: within the first 6 h after switch to "rescue treatment" ]
  2. paO2 at 2 h after switch to "rescue treatment" [ Time Frame: within the first 6 h after switch to "rescue treatment" ]
  3. paCO2 at 2 h after switch to "rescue treatment" [ Time Frame: within the first 6 h after switch to "rescue treatment" ]
  4. Base excess at 2 h after switch to "rescue treatment" [ Time Frame: within the first 6 h after switch to "rescue treatment" ]
  5. Successful rescue [ Time Frame: 72 h after switch to "rescue" treatment ]
    Defined as spontaneous breathing for ≥72h after starting "rescue" therapy, without reaching the criterion of "treatment failure"



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age <32+0 weeks
  • Birth weight <1500 g
  • Received mechanical ventilation via an endotracheal tube for ≥120 h
  • Caffeine treatment according to unit guidelines
  • paCO2 <65 mmHg with pH >7.2
  • FiO2 25-40% to maintain SpO2 at 90-94%.
  • Time-cycled, pressure-controlled ventilation: PIP ≤22 cm H2O, PEEP ≤6 cm H2O; Volume guarantee ventilation: Working Ppeak ≤22 cm H2O, PEEP ≤6 cm H2O; High frequency oscillation ventilation: Pmean ≤12 cm H2O, Amplitude ≤30 cm H2O
  • Decision of the attending clinician to extubate

Exclusion Criteria:

  • Major congenital malformation requiring surgery
  • Duct-dependent congenital heart disease
  • Neuromuscular disease
  • Participation in another randomized controlled trial
  • Death before reaching the eligibility criteria
  • Hydrocortisone treatment at the time of enrolment
  • Chronological age >28 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340299


Locations
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Germany
Dpt. of Neonatology, Charité - Universitätsmedizin Berlin
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Christoph Czernik, MD PhD Charite University, Berlin, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christoph Czernik, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02340299     History of Changes
Other Study ID Numbers: EA2/011/12
First Posted: January 16, 2015    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Keywords provided by Christoph Czernik, Charite University, Berlin, Germany:
High Frequency Oscillation Ventilation
Nasal Continuous Positive Airway Pressure
Airway Extubation
Prematurity
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases