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

Prince of Songkla University133 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Interventions

Non-invasive ventilationDEVICE

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)

Eligibility

Sex: ALLMin age: 1 DayMax age: 1 Month

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Partial Pressure CO2 (pCO2) : Data From the Crossover Phase of the Study

Data from the Crossover Phase of the study: After randomization only in neonate with arterial line, 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.

Time frame: 2 hours after each intervention

Secondary Outcomes

Number of Participants With Extubation Failure: Data From the Parallel Phase of the Study.

Data from the Parallel Phase of the study: The participant with and without arterial line was randomized. If The participant with arterial line was randomized to cross-over trial (randomized to NIV, then switched to another NIV for 2 hours, then switched to the first NIV \[parallel trial\]). If The participant without arterial line was randomized to parallel trial. Extubation failure will be defined by reintubation after NIV mode.

Time frame: up to 7 days after each intervention