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NHFOV Vs NIPPV Post-extubation in Preterm Neonates

NCT06620107 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-10-24

No results posted yet for this study

Summary

comparison between Noninvasive Intermittent Positive Pressure Ventilation (NIPPV) and Noninvasive High Frequency Oscillation Ventilation (NHFOV) post-extubation in preterm neonates as regards the efficacy and their possible complications.

Conditions

  • Noninvasive Ventilation

Interventions

DEVICE

noninvasive high frequency oscillation ventilation

cases of group A extubated on NHFOV, and it will be provided by CNO, Medin device, Germany) via binasal prongs with the following parameters: * MAP of 6 cmH2O and will be titrated targeting a FiO2 ≤ 25-30%, maximum FiO2 will be 40% and target oxygen saturation will be 90-95%. * Frequency of 8 Hz and can be changed within the range of 8-12 Hz. * Amplitude of 7 cmH2O and can be titrated within the range of 7-10 cmH2O according to PaCO2.

DEVICE

noninvasive positive pressure ventilation

NIPPV will be provided by any type of neonatal ventilator available in the unit via binasal prongs starting with the following parameters: * Positive end expiratory pressure (PEEP) of 5 cmH2O and can be titrated to 8 cmH2O according to the oxygenation . * Peak inspiratory pressure (PIP) of 15 cmH2O and can be titrated to 25 cmH2O ,according to oxygenation , PaCO2 level and the chest expansion . * FiO2 ≤ 25-30% and can be increased to 40 % maximally targeting oxygen saturation of 90-95% . * Inspiratory time of 0.40-0.50 s . * Rate of 30 bpm and can be increased to maximum 50 bpm . * Synchronization will not be applied.

Sponsors & Collaborators

  • Kafrelsheikh University

    lead OTHER

Principal Investigators

  • Heba SM El-Mahdy · Tanta University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-20
Primary Completion
2024-01-20
Completion
2024-01-20

Countries

  • Egypt

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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 NCT06620107 on ClinicalTrials.gov