Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02340299
• Date of registration: 10/01/2015
• Prospective Registration: No
• Primary sponsor: Charite University, Berlin, Germany
• Public title: Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2
• Scientific 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
• Date of first enrolment: January 1, 2015
• Target sample size: 6
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02340299
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Christoph Czernik, MD PhD
• Affiliation: Charite University, Berlin, Germany

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: 28 Days
Gender: All

Health Condition(s) or Problem(s) studied

Respiratory Distress Syndrome, Newborn

Respiratory Tract Diseases

Intervention(s)

Device: nHFOV

Device: nCPAP

Primary Outcome(s)

paCO2 at 72 h After Extubation [Time Frame: 64 h to 80 h]

Secondary Outcome(s)

Highly Viscous Secretions [Time Frame: within 72 hours after extubation]

paO2 at 72 h After Extubation [Time Frame: 64-80 h after extubation]

paCO2 at 2 h After Extubation [Time Frame: within the first 6 h after extubation]

Successful Extubation [Time Frame: 72 h after extubation]

Treatment Failure [Time Frame: within 7 days after extubation]

Reintubation [Time Frame: within 7 days after extubation]

Base Excess at 2 h After Extubation [Time Frame: within the first 6 h after extubation]

pH at 2 h After Extubation [Time Frame: within the first 6 h after extubation]

Base Excess at 72 h After Extubation [Time Frame: 64-80 h after extubation]

pH at 72 h After Extubation [Time Frame: 64-80 h after extubation]

Duration of Respiratory Support [Time Frame: until discharge]

paO2 at 2 h After Extubation [Time Frame: within the first 6 h after extubation]

Other Adverse Effects [Time Frame: until discharge]

Secondary ID(s)

EA2/011/12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02340299