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Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates

NCT05706428 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-11-07

No results posted yet for this study

Summary

The aim of the present work is to study the cardio-respiratory effects of non-invasive ventilation (nasal high-frequency ventilation and nasal CPAP) as an initial therapy of respiratory distress in moderate and late preterm infants as regard:

I. Primary outcomes:

* Duration of the non- invasive respiratory support.
* Need of invasive ventilation in the first 72 hours.
* Short-term complications such as air leak syndromes, pulmonary hemorrhage, intraventricular hemorrhage, and nasal trauma.

II. Secondary outcomes:

* Need for surfactant administration.
* Days on invasive mechanical ventilation.
* Days on supplemental oxygen.
* Duration of hospital stay.
* Mortality rate. III. Hemodynamic changes during the period of non-invasive ventilation.

Conditions

  • Ventilator Lung; Newborn
  • Hemodynamic Instability
  • Echocardiography

Interventions

DEVICE

NHFOV

The neonate patients with respiratory distress will have nasal high frequency ventilation as an initial mode of respiratory support.

DEVICE

NCPAP

The neonate patients with respiratory distress will have nasal continuous positive airway pressure as an initial mode of respiratory support.

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Nader Abdelminem Fasseh · Faculty of medicine, Alexandria University, Egypt

  • Mohamed Amen Hassan, MBChB · Faculty of medicine, Alexandria University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2023-09-28
Completion
2023-10-13

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 NCT05706428 on ClinicalTrials.gov