Integrated Echocardiography and Chest Ultrasound Assessment of Lung Recruitment in Preterm Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-3
SponsorAlexandria University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Known major congenital anomalies including congenital heart diseases.
Fetal hydrops.
Babies with congenital heart diseases
Trial design
Design model
Single group
Treatments tested in this trial
Lung recruitment
Other interventionestablishment of lung recruitment using high frequency ventilation and assessment with chest ultrasound and echocardiography
Treatment groups
72 Participants
are divided into 1 treatment groupGroup A: Lung recruitmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
first 3 days after birth2
Superior Vena Cava flow in ml/kg/min
Superior Vena Cava (SVC) Blood Flow using functional echocardiography
Time frame
first 3 days of life3
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.
Time frame
first 3 days of lifeSponsors and contacts
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Source ClinicalTrials.gov