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Completed

NCT Number: NCT04323397

Nasal HFOV Versus Nasal SIPPV in Neonate Following Extubation: RCT 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.

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Key information

Age range

1 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Songklanagarind Hospital, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive ventilation

Device

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)

Primary outcomes

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

    Time frame: 2 hours after each intervention

    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.

Secondary outcomes

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

    Time frame: up to 7 days after each intervention

    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.

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

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

Acronym: nHFOnSIPPV

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 26, 2020
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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