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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Distress Syndrome, Newborn

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: mohamed Khalifa, MD; Phone Number: 202 01010736078; Email: drkhalifa2233@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University
  • Cairo, Egypt
    • Neonatal Intensive Care Units (NICUs), Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Preterm neonates admitted to Ain shams University Hospital NICUs fulfilling the inclusion criteria

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: preterm, respiratory distress, LUS, TFC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: MD 03/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No