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Noninvasive High Frequency Oscillatory Ventilation as a Post-extubation Respiratory Support in Neonates

NCT05493527 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-08-09

No results posted yet for this study

Summary

A randomized controlled trial comparing Noninvasive high frequency oscillatory ventilation (NHFOV) and Noninvasive positive pressure ventilation (NIPPV) as post-extubation respiratory support in preterm neonates with respiratory distress syndrome(RDS)

Conditions

  • Infant, Premature, Diseases
  • Infant, Newborn, Disease
  • Respiratory Tract Diseases
  • RDS

Interventions

DEVICE

noninvasive high frequency oscillatory ventilation

A time-cycled, pressure-limited, and continuous-flow neonatal ventilator (SLE6000; SLE) was used for neonates assigned to the NHFOV group. The settings were as follows: 1. a frequency of 10 Hertz ( range, 8-12 Hz); 2. an inspiratory time of 50% (1:1) 3. an oscillation amplitude of 35 centimeter of water column (cmH2O) (subsequent regulation range, 20-40 cmH2O) Oscillation amplitude would be regulated according to the level of carbon dioxide(CO2). Visible chest oscillation was not necessary because elimination of CO2 during NHFOV could also occur in the upper respiratory airway dead space 4. Mean airway pressure (MAP) of 10 cm H2O ( range, 7-15) MAP was regulated according to an open lung recruitment strategy 5. fraction of inspired oxygen (FIO2) regulated from 0.21 to 0.40 in order to maintain saturation from 90% to 95% as determined with a pulse oximeter.

DEVICE

noninvasive positive pressure ventilation

NIPPV will be delivered by ventilator generating the targeted pressures. Infants will be on: 1. Peep ranging from 5 to 10 cmH2O, 2. Peak inspiratory pressure range 15-25 cmH2O 3. Rate range 40-50 breath/minute 4. FIO2 regulated from 0.21 to 0.40 in order to maintain saturation from 90% to 95% as determined with a pulse oximeter.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-08-15
Completion
2022-08-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05493527 on ClinicalTrials.gov