Nasal HFOV Versus Nasal SIPPV in Neonate Following Extubation: RCT Crossover Study

Noninvasive Ventilation Clinical Trial

— nHFOnSIPPV  

Official title:

Nasal High Frequency Oscillatory Versus Synchronized Intermittent Positive Pressure Ventilation in Neonate Following Extubation: Randomized Controlled Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04323397
• Other study ID #: 6238211
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: June 2023
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The primary outcome (pCO2) was measured by crossover RCT. The secondary outcome (reintubation within 7 days) was measured by paralleled RCT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: August 1, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• High-Frequency Ventilation
• Intermittent Positive-Pressure Ventilation
• Newborn Morbidity
• Noninvasive Ventilation

Intervention

Device:
• Non-invasive ventilation
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)

Locations

Country	Name	City	State
Thailand	Songklanagarind Hospital, Prince of Songkla University	Hat-Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

References & Publications (6)

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. — View Citation

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. — View Citation

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-2017-3 — View Citation

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. — View Citation

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. — View Citation

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/s12519-01 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	partial pressure CO2 (pCO2)	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	extubation failure	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