Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2

Respiratory Tract Diseases Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02340299
• Other study ID #: EA2/011/12
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: July 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Tract Diseases

Intervention

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

Locations

Country	Name	City	State
Germany	Dpt. of Neonatology, Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pH at 2 h After Switch to "Rescue Treatment"		within the first 6 h after switch to "rescue treatment"
Other	paO2 at 2 h After Switch to "Rescue Treatment"		within the first 6 h after switch to "rescue treatment"
Other	paCO2 at 2 h After Switch to "Rescue Treatment"		within the first 6 h after switch to "rescue treatment"
Other	Base Excess at 2 h After Switch to "Rescue Treatment"		within the first 6 h after switch to "rescue treatment"
Other	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
Primary	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
Secondary	pH at 2 h After Extubation		within the first 6 h after extubation
Secondary	paO2 at 2 h After Extubation		within the first 6 h after extubation
Secondary	paCO2 at 2 h After Extubation		within the first 6 h after extubation
Secondary	Base Excess at 2 h After Extubation		within the first 6 h after extubation
Secondary	pH at 72 h After Extubation		64-80 h after extubation
Secondary	paO2 at 72 h After Extubation		64-80 h after extubation
Secondary	Base Excess at 72 h After Extubation		64-80 h after extubation
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"	72 h after extubation
Secondary	Treatment Failure	Defined as the number of patients reaching the criterion of "treatment failure"	within 7 days after extubation
Secondary	Reintubation	Defined as the number of patients being reintubated	within 7 days after extubation
Secondary	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
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	until discharge
Secondary	Duration of Respiratory Support	Total duration of mechanical ventilation, total duration of supplemental oxygen, number of infants discharged with home oxygen	until discharge