- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04323397
Nasal HFOV Versus Nasal SIPPV in Neonate Following Extubation: RCT Crossover Study (nHFOnSIPPV)
Nasal High Frequency Oscillatory Versus Synchronized Intermittent Positive Pressure Ventilation in Neonate Following Extubation: Randomized Controlled Crossover Study
Mechanical ventilation was introduced to treat respiratory failure in preterm infants or sick neonates then improvements in survival (1,2). However, the complications from short or long term use of ventilation can result in unintended harm or burden (e.g., air leak syndrome, pneumonia, bronchopulmonary dysplasia, neurological injury, retinopathy of prematurity) (3,4). To reduce these risks, clinicians should aggressive extubated neonates as early as possible. Respiratory (focus on blood gas as well as partial pressure CO2 [pCO2]) or extubation (focus on clinical condition as well as reintubation) failure was worrisome in pediatrician and parents if the neonate was reintubated owing to complete recovery of lung disease or inadequate respiratory drive.
Non-invasive ventilation (NIV) was supported for primary respiratory support (initial mode before endotracheal intubation) or post-extubation. Nasal continuous positive airway pressure (nCPAP) was familiar to NIV mode in neonatal respiratory support. Nowadays, the new NIV modalities are nasal intermittent synchronized positive pressure ventilation (nSIPPV) and nasal high frequency oscillation (nHFO). To increase the likelihood of nCPAP success, other new modalities of NIV may be interesting. From theory, nSIPPV and nHFO combines peak inspiratory pressure (PIP) with synchrony and high-frequency oscillations without synchrony above CPAP, respectively. From meta-analysis, nSIPPV and nHFO were statistically significant superior than nCPAP both respiratory and extubation failure in neonate (5,6).
The aim of our study was to investigate the efficacy of nHFOV and nSIPPV for CO2 clearance and reintubation rate after extubated neonates. The investigators hypothesized that nHFOV mode would improve CO2 clearance better than nSIPPV mode.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Songkhla
-
Hat-Yai, Songkhla, Thailand, 90110
- Songklanagarind Hospital, Prince of Songkla University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Born in hospital and admit in NICU
- The first endotracheal intubation and need NIV if extubation
- Umbilical arterial catheterization to draw the blood gas
- Neonate has not been intervened from another RCT study
Exclusion Criteria:
- Major congenital anomalies or chromosomal abnormalities
- Neuromuscular diseases
- Upper respiratory tract abnormalities
- Suspected congenital lung diseases or pulmonary hypoplasia
- Need for surgery known before the first extubation
- Grade IV intraventricular hemorrhage occurring before the first extubation
- Palliative care
- Parents' decision not to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: nasal high frequency oscillatory ventilation
nHFO: flow 8-10 L/minute, frequency 10 Hz, MAP = "MAP (before extubation) + 2" or "8 (preterm), 10 (term)" cmH2O, dP = "2-3 times of MAP with visible chest oscillations" or 25-35 cmH2O, I:E = 1:1, FiO2 = "FiO2 (before extubation) + 0.1-0.2"
keep targeted SpO2 90-94%
|
Intervention nasal high frequency oscillatory ventilation (nHFOV) and nasal synchronized intermittent positive pressure ventilation (nSIPPV) were generated by neonatal ventilators (SLE6000 infant ventilators, United Kingdom) using bi-nasal prongs (RAM cannula, NEOTECH®, USA) or the nasal mask of the same type for both ventilation modes.
The size of the prongs was determined by the infant's weight.
The largest possible prongs were used, with a snug fit to avoid leakage.
Pacifier for preterm and term neonate (Jollypop™, USA) was taken to avoid leakage from the mouth.
The disposable ventilator circuit (Fisher & Paykel RT268™, Evaqua Dual Limb Infant Breathing Circuit Kit with Evaqua 2 Technology and Pressure Line, Flow > 4L/min, New Zealand) was used.
The initial NIV setting was (7) described in arm description.
(above)
|
Experimental: nasal synchronized intermittent positive pressure ventilation
nSIPPV: flow 8-10 L/minute, rate 60/minute, PIP = "PIP (before extubation) + 2-5" or "20 (preterm), 25 (term)" cmH2O, PEEP = 5 cmH2O, IT = 0.5 s, FiO2 = "FiO2 (before extubation) + 0.1-0.2"
keep targeted SpO2 90-94%.
The highest trigger sensitivity avoiding auto triggering was selected.
|
Intervention nasal high frequency oscillatory ventilation (nHFOV) and nasal synchronized intermittent positive pressure ventilation (nSIPPV) were generated by neonatal ventilators (SLE6000 infant ventilators, United Kingdom) using bi-nasal prongs (RAM cannula, NEOTECH®, USA) or the nasal mask of the same type for both ventilation modes.
The size of the prongs was determined by the infant's weight.
The largest possible prongs were used, with a snug fit to avoid leakage.
Pacifier for preterm and term neonate (Jollypop™, USA) was taken to avoid leakage from the mouth.
The disposable ventilator circuit (Fisher & Paykel RT268™, Evaqua Dual Limb Infant Breathing Circuit Kit with Evaqua 2 Technology and Pressure Line, Flow > 4L/min, New Zealand) was used.
The initial NIV setting was (7) described in arm description.
(above)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
partial pressure CO2 (pCO2)
Time Frame: 4 hours after NIV start
|
After randomization, the initial non-invasive ventilation (NIV) was started then blood gas was obtained after 2 hours.
The participant was switched to another NIV and blood gas was obtained after 2 hours.
|
4 hours after NIV start
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
extubation failure
Time Frame: 7 days after extubation
|
The participant was continued with the last NIV mode until the NIV was stopped.
The participant was excluded if severe respiratory failure with reintubation during 4 hours after intervention.
Extubation failure will be defined by reintubation after NIV mode.
|
7 days after extubation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anucha Thatrimontrichai, M.D., Prince of Songkla University
Publications and helpful links
General Publications
- De Luca D, Dell'Orto V. Non-invasive high-frequency oscillatory ventilation in neonates: review of physiology, biology and clinical data. Arch Dis Child Fetal Neonatal Ed. 2016 Nov;101(6):F565-F570. doi: 10.1136/archdischild-2016-310664. Epub 2016 Jun 28.
- Murdock AI, Linsao L, Reid MM, Sutton MD, Tilak KS, Ulan OA, Swyer PR. Mechanical ventilation in the respiratory distress syndrome: a controlled trial. Arch Dis Child. 1970 Oct;45(243):624-33. doi: 10.1136/adc.45.243.624.
- Reid DH, Tunstall ME, Mitchell RG. A controlled trial of artificial respiration in the respiratory-distress syndrome of the newborn. Lancet. 1967 Mar 11;1(7489):532-3. doi: 10.1016/s0140-6736(67)92112-5. No abstract available.
- Thatrimontrichai A, Rujeerapaiboon N, Janjindamai W, Dissaneevate S, Maneenil G, Kritsaneepaiboon S, Tanaanantarak P. Outcomes and risk factors of ventilator-associated pneumonia in neonates. World J Pediatr. 2017 Aug;13(4):328-334. doi: 10.1007/s12519-017-0010-0. Epub 2017 Jan 25.
- Ferguson KN, Roberts CT, Manley BJ, Davis PG. Interventions to Improve Rates of Successful Extubation in Preterm Infants: A Systematic Review and Meta-analysis. JAMA Pediatr. 2017 Feb 1;171(2):165-174. doi: 10.1001/jamapediatrics.2016.3015.
- Klotz D, Schneider H, Schumann S, Mayer B, Fuchs H. Non-invasive high-frequency oscillatory ventilation in preterm infants: a randomised controlled cross-over trial. Arch Dis Child Fetal Neonatal Ed. 2018 Jul;103(4):F1-F5. doi: 10.1136/archdischild-2017-313190. Epub 2017 Sep 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 6238211
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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