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

June 11, 2023 updated by: Anucha Thatrimontrichai, Prince of Songkla University

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

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Songkhla
      • Hat-Yai, Songkhla, Thailand, 90110
        • Songklanagarind Hospital, Prince of Songkla University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anucha Thatrimontrichai, M.D., Prince of Songkla University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

March 25, 2020

First Posted (Actual)

March 26, 2020

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 11, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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