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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ventilator Lung, Echocardiography, Chest Ultrasound, High Frequency Ventilation, Lung Recruitment

Intervention / Treatment
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* Other: Lung recruitment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung recruitment<br>preterm infants with moderate to severe respiratory distress | Other: Lung recruitment<br>* establishment of lung recruitment using high frequency ventilation and assessment with chest ultrasound and echocardiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature infants