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

Echocardiography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05726578
• Other study ID #: 0201752
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: February 2024
• Source: Alexandria University
• Contact: Marwa M Farag, PhD
• Phone: 01288681788
• Email: d.marwa.farag[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: June 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Echocardiography
• Ventilator Lung

Intervention

Other:
• Lung recruitment
establishment of lung recruitment using high frequency ventilation and assessment with chest ultrasound and echocardiography

Locations

Country	Name	City	State
Egypt	Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Superior Vena Cava flow in ml/kg/min	Superior Vena Cava (SVC) Blood Flow using functional echocardiography	first 3 days of life
Primary	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