Clinical trial NCT02340299: Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Respiratory Tract Diseases
Keywords: High Frequency Oscillation Ventilation
Nasal Continuous Positive Airway Pressure
Airway Extubation
Prematurity
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-01-16
Enrollment: 6
Sex: ALL
Minimum age (years): 5
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: paCO2 at 72 h After Extubation
timeFrame: 64 h to 80 h
Secondary outcomes:
measure: pH at 2 h After Extubation
timeFrame: within the first 6 h after extubation
measure: paO2 at 2 h After Extubation
timeFrame: within the first 6 h after extubation
measure: paCO2 at 2 h After Extubation
timeFrame: within the first 6 h after extubation
measure: Base Excess at 2 h After Extubation
timeFrame: within the first 6 h after extubation
measure: pH at 72 h After Extubation
timeFrame: 64-80 h after extubation
measure: paO2 at 72 h After Extubation
timeFrame: 64-80 h after extubation
measure: Base Excess at 72 h After Extubation
timeFrame: 64-80 h after extubation
measure: Successful Extubation
timeFrame: 72 h after extubation
measure: Treatment Failure
timeFrame: within 7 days after extubation
measure: Reintubation
timeFrame: within 7 days after extubation
measure: Highly Viscous Secretions
timeFrame: within 72 hours after extubation
measure: Other Adverse Effects
timeFrame: until discharge
measure: Duration of Respiratory Support
timeFrame: until discharge
Other outcomes:
measure: pH at 2 h After Switch to "Rescue Treatment"
timeFrame: within the first 6 h after switch to "rescue treatment"
measure: paO2 at 2 h After Switch to "Rescue Treatment"
timeFrame: within the first 6 h after switch to "rescue treatment"
measure: paCO2 at 2 h After Switch to "Rescue Treatment"
timeFrame: within the first 6 h after switch to "rescue treatment"
measure: Base Excess at 2 h After Switch to "Rescue Treatment"
timeFrame: within the first 6 h after switch to "rescue treatment"
measure: Successful Rescue
timeFrame: 72 h after switch to "rescue" treatment
Locations:
city: Berlin
country: Germany
facility: Dpt. of Neonatology, Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Christoph Czernik, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.