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NCT Number: NCT05726578

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

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.

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Key information

Conditions

Ventilator Lung Chest Ultrasound Echocardiography Female Urogenital Diseases and Pregnancy Complications High Frequency Ventilation Lung Recruitment Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 hour–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marwa Mohamed Farag, Alexandria, Egypt

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung recruitment

Other

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

Primary outcomes

  1. chest US

    Time frame: 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

  2. Superior Vena Cava flow in ml/kg/min

    Time frame: first 3 days of life

    Superior Vena Cava (SVC) Blood Flow using functional echocardiography

  3. estimated pulmonary artery pressure in mmHg

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marwa M Farag, PhD

CONTACT

[email protected]

01288681788 ext. +2

Mohamed Hany Saad, MBBCh

CONTACT

[email protected]

01282226826 ext. +2

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2023
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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