Clinical trial NCT05594030: Thoracic Fluid Content by Electric Bioimpedance Versus Lung Ultrasound in Preterm Neonates With Respiratory Distress
Official title: Thoracic Fluid Content by Electric Bioimpedance Versus Lung Ultrasound in Preterm Neonates With Respiratory Distress
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Distress Syndrome, Newborn
Keywords: preterm, respiratory distress, LUS, TFC
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm neonates admitted to Ain shams University Hospital NICUs fulfilling the inclusion criteria

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 72 hours
Secondary outcomes:
measure: TFC parameters may offer the ability to monitor lung fluid content and provide longitudinal follow-up during interventions and disease processes.
timeFrame: 72 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
city: Cairo
country: Egypt
facility: Neonatal Intensive Care Units (NICUs), Ain Shams University
Study officials:
References: