Integrated Echocardiography and Chest Ultrasound Assessment of Lung Recruitment in Preterm Infants

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ventilator Lung; Echocardiography; Lung Recruitment; Chest Ultrasound; High Frequency Ventilation
• Intervention / Treatment: Other: Lung recruitment

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwa M Farag, PhD; Phone Number: +2 01288681788; Email: d.marwa.farag@gmail.com
• Study Contact Backup: Name: Mohamed Hany Saad, MBBCh; Phone Number: +2 01282226826; Email: mohamedhany_90@icloud.com

Study Locations

• Egypt
  • Alexandria, Egypt, 21131
    • Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.
    • Contact: Marwa M Farag, PhD; Phone Number: +2 01009795810; Email: d.marwa.farag@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 3 days (Child)
• Accepts Healthy Volunteers: No

Description

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:

1. Known major congenital anomalies including congenital heart diseases.
2. Fetal hydrops.
3. Babies with congenital heart diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lung recruitment; preterm infants with moderate to severe respiratory distress	Other: Lung recruitment; establishment of lung recruitment using high frequency ventilation and assessment with chest ultrasound and echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chest US	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; presence Of A lines, B-lines or C-profile; presence or absence of pleural sliding	first 3 days after birth
Superior Vena Cava flow in ml/kg/min	Superior Vena Cava (SVC) Blood Flow using functional echocardiography	first 3 days of life
estimated pulmonary artery pressure in mmHg	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.	first 3 days of life

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Chair: Mohamed Hazem Wagih Gouda, PhD, Alexandria University; Study Director: Ali Mohamed Abd Almohsen, PhD, Alexandria University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Premature infants
• Other Study ID Numbers: 0201752

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No