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

Sponsor

Alexandria University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05726578

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventilator Lung Echocardiography Chest Ultrasound High Frequency Ventilation Lung Recruitment	Other: Lung recruitment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Hour to 3 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.	Alexandria		Egypt	21131

Sponsors and Collaborators

Alexandria University

Investigators

Study Chair: Mohamed Hazem Wagih Gouda, PhD, Alexandria University
Study Director: Ali Mohamed Abd Almohsen, PhD, Alexandria University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marwa Mohamed Farag, Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine, Alexandria University

ClinicalTrials.gov Identifier:

NCT05726578

Other Study ID Numbers:

0201752

First Posted:

Feb 14, 2023

Last Update Posted:

Feb 15, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marwa Mohamed Farag, Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine, Alexandria University

Premature infants

Study Results

No Results Posted as of Feb 15, 2023