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

NCT05594030 | Unknown

• 1 other identifier: MD 03/2022
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

preterm, respiratory distress, LUS, TFC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• TFC parameters may offer the ability to monitor lung fluid content and provide longitudinal follow-up during interventions and disease processes.

  72 hours

Eligibility Criteria

• Age: 1 Minute - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Preterm neonates with evidence of any of the following:
• Chromosomal anomalies Mechanical ventilation or received endotracheal surfactant before first assessment

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

Ain shams university

Cairo, Egypt

Location

Neonatal Intensive Care Units (NICUs), Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn; Premature Birth; Dyspnea

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

mohamed Khalifa, MD

CONTACT

01010736078; drkhalifa2233@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

EG (2)