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

NCT05726578 | Recruiting

• 1 other identifier: 0201752
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Ventilator Lung; Echocardiography; Chest Ultrasound; High Frequency Ventilation; Lung Recruitment

Keywords

Premature infants

Outcome Measures

Primary Outcomes (3)

• 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 1. presence Of A lines, B-lines or C-profile 2. 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

Study Arms (1)

Lung recruitment

EXPERIMENTAL

preterm infants with moderate to severe respiratory distress

Other: Lung recruitment

Interventions

Lung recruitment OTHER

establishment of lung recruitment using high frequency ventilation and assessment with chest ultrasound and echocardiography

Lung recruitment

Eligibility Criteria

• Age: 1 Hour - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (2)

Marwa Mohamed Farag

Alexandria, 0325, Egypt

RECRUITING

Neonatal Intensive Care Unit (NICU) of Alexandria University Maternity Hospital.

Alexandria, 21131, Egypt

NOT YET RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Mohamed Hazem Wagih Gouda, PhD

  Alexandria University

  STUDY CHAIR

• Ali Mohamed Abd Almohsen, PhD

  Alexandria University

  STUDY DIRECTOR

Central Study Contacts

Marwa M Farag, PhD

CONTACT

01288681788; d.marwa.farag@gmail.com

Mohamed Hany Saad, MBBCh

CONTACT

01282226826; mohamedhany_90@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator and Lecturer in Pediatrics, Faculty of Medicine

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 14, 2023
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

EG (2)