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Clinical Trials/NCT05726578
NCT05726578
Recruiting
Not Applicable

Integrated Echocardiography and Chest Ultrasound Assessment of Lung Recruitment in Preterm Infants Using High Frequency Ventilation

Alexandria University2 sites in 1 country72 target enrollmentJuly 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventilator Lung
Sponsor
Alexandria University
Enrollment
72
Locations
2
Primary Endpoint
chest US
Status
Recruiting
Last Updated
11 months ago

Overview

Brief Summary

The primary aim of this work is to evaluate the role of high frequency oscillatory ventilation (HFOV) in recruitment of lung in preterm newborns 32 to 37 weeks gestational age with moderate to severe respiratory distress. The secondary aim is to evaluate the role of chest ultrasound in monitoring of lung recruitment in comparison to routine chest x ray in those babies. Also cardiac hemodynamics will be assesed using functional echocardiography.

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
July 1, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marwa Mohamed Farag

Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine

Alexandria University

Eligibility Criteria

Inclusion Criteria

  • Infants will be enrolled if they are 32 to 37 weeks of gestational age, have respiratory distress (RD) in the first 24 h of life, intubated and have invasive respiratory support using HFOV. Signs of RD are tachypnea (respiratory rate \> 60/min), grunting, nasal flaring, chest retraction, and need of oxygen supplementation or other respiratory support.

Exclusion Criteria

  • Known major congenital anomalies including congenital heart diseases.
  • Fetal hydrops.
  • Babies with congenital heart diseases

Outcomes

Primary Outcomes

chest US

Time Frame: first 3 days after birth

A mobile device (PHILIPS ® HD11 XE) with a 10-MHz linear probe will be used for chest ultrasound the 12 lung zones will be assessed regarding 1. presence Of A lines, B-lines or C-profile 2. presence or absence of pleural sliding

estimated pulmonary artery pressure in mmHg

Time Frame: first 3 days of life

Pulmonary artery pressure (PAP) will be assessed by measuring tricuspid valve regurgitation peak velocity: this will be measured in apical 4 chamber view, with continous wave Doppler using modified Bernoulli equation. Systolic pulmonary artery pressure is equivalent to right ventricular systolic pressure in absence of outflow obstruction. Systolic Pulmonary Artery Pressure (SPAP) = Right Ventricular Systolic Pressure = 4x TR2 + Right Atrial Pressure (RAP), with RAP= 3-5 mmHg.

Superior Vena Cava flow in ml/kg/min

Time Frame: first 3 days of life

Superior Vena Cava (SVC) Blood Flow using functional echocardiography

Study Sites (2)

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