Thoracic Fluid Content by Electric Bioimpedance Versus Lung Ultrasound in Preterm Neonates With Respiratory Distress

Respiratory Distress Syndrome, Newborn Clinical Trial

Official title:

Thoracic Fluid Content by Electric Bioimpedance Versus Lung Ultrasound in Preterm Neonates With Respiratory Distress

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05594030
• Other study ID #: MD 03/2022
• Status: Not yet recruiting
• Start date: November 1, 2022
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Ain Shams University
• Contact: mohamed Khalifa, MD
• Phone: 01010736078
• Email: drkhalifa2233[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A prospective cohort study aims to evaluate the predictive value of thoracic fluid content measured by electric bioimpedance for detecting the need for surfactant administration or positive pressure ventilation requirement; whether invasive or non-invasive; in preterm neonates with respiratory distress and to compare it to lung ultrasound.

Description:

Electrical cardiometry (bioimpedance) is an impedance-based method that has been recently introduced for continuous noninvasive hemodynamic monitoring for cardiac output (CO) and TFC in both term and preterm infants.

TFC is the sum of the total fluid volume found in the chest cavity; it is measured as the baseline resistance (bioimpedance) to the passage of a small electrical current through all chest tissues.

Larger TFC indicates a higher total thoracic fluid volume. TFC measurement has been correlated with heart failure symptoms, net fluid balance, and chest radiographic findings of abnormal pulmonary fluid content in adults.

Lung ultrasound (LUS) is a reliable technique for physicians to complement physical examination findings and has emerged as an alternative option to overcome the limitations of chest x rays (CXRs). Moreover, LUS shows better diagnostic accuracy than CXR in some critical conditions and has been successfully adapted in NICUs for the diagnosis of several diseases.

We thought that TFC monitoring may be able to predict the need for surfactant administration or positive pressure ventilation requirement; whether invasive or non-invasive; in preterm neonates with respiratory distress comparable to LUS.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 3 Days

Eligibility

Inclusion Criteria:

• Preterm neonates with gestational age = 34 weeks, admitted with respiratory distress:

Defined as the presence of at least two of the following clinical symptoms:

Tachypnea, grunting, retractions (subcostal, intercostal, suprasternal), nasal flaring and other symptoms include apnea, bradypnea, irregular (seesaw) breathing, inspiratory stridor, wheezes and hypoxia

Exclusion Criteria:

• Preterm neonates with evidence of any of the following:

Chromosomal anomalies Mechanical ventilation or received endotracheal surfactant before first assessment

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
Egypt	Ain shams university	Cairo
Egypt	Neonatal Intensive Care Units (NICUs), Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	predictive value of thoracic fluid content measurement for detecting the need for surfactant administration or positive pressure ventilation requirement in preterm neonates with respiratory distress and to compare it to lung ultrasound.	Thoracic fluid content will be measured on enrolment (TFC10 and follow up will be done after 3 days (TFC2) and at extubation from mechanical ventilation (TFC3) by electrical bioimpedance	72 hours
Secondary	TFC parameters may offer the ability to monitor lung fluid content and provide longitudinal follow-up during interventions and disease processes.	Thoracic fluid content will be measured on enrolment (TFC10 and follow up will be done after 3 days (TFC2) and at extubation from mechanical ventilation (TFC3) by electrical bioimpedance	72 hours