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Slow recruitment
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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).
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):
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nHFOV | Experimental | 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. |
|
| nCPAP | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nHFOV | Device | Extubation to ventilator-derived nHFOV using binasal prongs |
| |
| Measure | Description | Time Frame |
|---|---|---|
| paCO2 at 72 h After Extubation | Partial pressure of arterial carbon dioxide assessed between 64 and 80 hours, and on average 72 hours. | 64 h to 80 h |
| Measure | Description | Time Frame |
|---|---|---|
| pH at 2 h After Extubation | within the first 6 h after extubation | |
| paO2 at 2 h After Extubation | within the first 6 h after extubation | |
| paCO2 at 2 h After Extubation |
| Measure | Description | Time Frame |
|---|---|---|
| pH at 2 h After Switch to "Rescue Treatment" | within the first 6 h after switch to "rescue treatment" | |
| paO2 at 2 h After Switch to "Rescue Treatment" | within the first 6 h after switch to "rescue treatment" |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Czernik, MD PhD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dpt. of Neonatology, Charité - Universitätsmedizin Berlin | Berlin | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31023363 | Derived | Fischer HS, Buhrer C, Czernik C. Hazards to avoid in future neonatal studies of nasal high-frequency oscillatory ventilation: lessons from an early terminated trial. BMC Res Notes. 2019 Apr 25;12(1):237. doi: 10.1186/s13104-019-4268-2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. nHFOV: Extubation to ventilator-derived nHFOV using binasal prongs |
| FG001 | 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. nCPAP: Extubation to ventilator-derived nCPAP using binasal prongs |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. nHFOV: Extubation to ventilator-derived nHFOV using binasal prongs |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | paCO2 at 72 h After Extubation | Partial pressure of arterial carbon dioxide assessed between 64 and 80 hours, and on average 72 hours. | In patients that were reintubated within 72 h, the primary outcome, paCO2 72 h after extubation, could not be assessed. In the nCPAP group, all patients had to be reintubated within 72 h. The primary outcome, paCO2 72 h after extubation, could therefore only be assessed in the nHFOV group. | Posted | Median | Full Range | mmHg | 64 h to 80 h |
|
Adverse event data was collected until discharge from the neonatal unit. Patients were discharged approximately at 3 months of age.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. nHFOV: Extubation to ventilator-derived nHFOV using binasal prongs |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Highly viscous secretions | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PD Dr. Christoph Czernik, principal investigator | Charité - Universitätsmedizin Berlin | +49 30 450 | 566122 | christoph.czernik@charite.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2012 | Jul 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D012140 | Respiratory Tract Diseases |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
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| nCPAP |
| Device |
Extubation to ventilator-derived nCPAP using binasal prongs |
|
| within the first 6 h after extubation |
| Base Excess at 2 h After Extubation | within the first 6 h after extubation |
| pH at 72 h After Extubation | 64-80 h after extubation |
| paO2 at 72 h After Extubation | 64-80 h after extubation |
| Base Excess at 72 h After Extubation | 64-80 h after extubation |
| Successful Extubation | Defined as the number of patients breathing spontaneously in their assigned treatment group for ≥72h without reaching the criterion of "treatment failure" | 72 h after extubation |
| Treatment Failure | Defined as the number of patients reaching the criterion of "treatment failure" | within 7 days after extubation |
| Reintubation | Defined as the number of patients being reintubated | within 7 days after extubation |
| Highly Viscous Secretions | Defined as the documented number of episodes of airway obstruction due to highly viscous secretions per patient | within 72 hours after extubation |
| Other Adverse Effects | 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 | until discharge |
| Duration of Respiratory Support | Total duration of mechanical ventilation, total duration of supplemental oxygen, number of infants discharged with home oxygen | until discharge |
| paCO2 at 2 h After Switch to "Rescue Treatment" | within the first 6 h after switch to "rescue treatment" |
| Base Excess at 2 h After Switch to "Rescue Treatment" | within the first 6 h after switch to "rescue treatment" |
| Successful Rescue | Defined as spontaneous breathing for ≥72h after starting "rescue" therapy, without reaching the criterion of "treatment failure" | 72 h after switch to "rescue" treatment |
| BG001 | 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. nCPAP: Extubation to ventilator-derived nCPAP using binasal prongs |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. nCPAP: Extubation to ventilator-derived nCPAP using binasal prongs |
|
|
| Secondary | pH at 2 h After Extubation | Not Posted | within the first 6 h after extubation | Participants |
| Secondary | paO2 at 2 h After Extubation | Not Posted | within the first 6 h after extubation | Participants |
| Secondary | paCO2 at 2 h After Extubation | Not Posted | within the first 6 h after extubation | Participants |
| Secondary | Base Excess at 2 h After Extubation | Not Posted | within the first 6 h after extubation | Participants |
| Secondary | pH at 72 h After Extubation | Not Posted | 64-80 h after extubation | Participants |
| Secondary | paO2 at 72 h After Extubation | Not Posted | 64-80 h after extubation | Participants |
| Secondary | Base Excess at 72 h After Extubation | Not Posted | 64-80 h after extubation | Participants |
| Secondary | Successful Extubation | Defined as the number of patients breathing spontaneously in their assigned treatment group for ≥72h without reaching the criterion of "treatment failure" | Not Posted | 72 h after extubation | Participants |
| Secondary | Treatment Failure | Defined as the number of patients reaching the criterion of "treatment failure" | Not Posted | within 7 days after extubation | Participants |
| Secondary | Reintubation | Defined as the number of patients being reintubated | Not Posted | within 7 days after extubation | Participants |
| Secondary | Highly Viscous Secretions | Defined as the documented number of episodes of airway obstruction due to highly viscous secretions per patient | Not Posted | within 72 hours after extubation | Participants |
| Secondary | Other Adverse Effects | 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 | Not Posted | until discharge | Participants |
| Secondary | Duration of Respiratory Support | Total duration of mechanical ventilation, total duration of supplemental oxygen, number of infants discharged with home oxygen | Not Posted | until discharge | Participants |
| Other Pre-specified | pH at 2 h After Switch to "Rescue Treatment" | Not Posted | within the first 6 h after switch to "rescue treatment" | Participants |
| Other Pre-specified | paO2 at 2 h After Switch to "Rescue Treatment" | Not Posted | within the first 6 h after switch to "rescue treatment" | Participants |
| Other Pre-specified | paCO2 at 2 h After Switch to "Rescue Treatment" | Not Posted | within the first 6 h after switch to "rescue treatment" | Participants |
| Other Pre-specified | Base Excess at 2 h After Switch to "Rescue Treatment" | Not Posted | within the first 6 h after switch to "rescue treatment" | Participants |
| Other Pre-specified | Successful Rescue | Defined as spontaneous breathing for ≥72h after starting "rescue" therapy, without reaching the criterion of "treatment failure" | Not Posted | 72 h after switch to "rescue" treatment | Participants |
| 0 |
| 4 |
| 0 |
| 4 |
| 2 |
| 4 |
| EG001 | 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. nCPAP: Extubation to ventilator-derived nCPAP using binasal prongs | 0 | 2 | 0 | 2 | 0 | 2 |
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| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |