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

Not Applicable

Recruiting

• Conditions: Lung Recruitment; High Frequency Ventilation; Echocardiography; Chest Ultrasound; Ventilator Lung
• Interventions: Other: Lung recruitment

• Registration Number: NCT05726578
• Lead Sponsor: Alexandria University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-03
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-14
• Study Start: 2024-07-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-04-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lung recruitment	Lung recruitment	preterm infants with moderate to severe respiratory distress

Primary Outcome Measures

Name	Time	Method
Superior Vena Cava flow in ml/kg/min	first 3 days of life	Superior Vena Cava (SVC) Blood Flow using functional echocardiography
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; 1. presence Of A lines, B-lines or C-profile; 2. presence or absence of pleural sliding
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.

Trial Locations

Locations (2)

Marwa Mohamed Farag; 🇪🇬 Alexandria, Egypt

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.; 🇪🇬 Alexandria, Egypt