Respiratory Distress Syndrome, NewbornNCT05594030
Thoracic Fluid Content by Electric Bioimpedance Versus Lung Ultrasound in Preterm Neonates With Respiratory Distress
An observational study of Respiratory Distress Syndrome, Newborn, run by Ain Shams University at 2 sites in Egypt.
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… Read more about this study
- Who is it for?
- Ages 1 minute to 3 days
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- How many people
- 70 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Nov 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 3 days
- All sexes
- No healthy volunteers
- Child
Study population: Preterm neonates admitted to Ain shams University Hospital NICUs fulfilling the inclusion criteria
Who may be able to join
- 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
Who cannot join
- Preterm neonates with evidence of any of the following:
- Chromosomal anomalies Mechanical ventilation or received endotracheal surfactant before first assessment
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Ain shams university
Cairo
Neonatal Intensive Care Units (NICUs), Ain Shams University
Cairo
About this study
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.
Read the 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.
- Conditions
- Respiratory Distress Syndrome, Newborn
- Keywords
- preterm, respiratory distress, LUS, TFC
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Premature Birth, Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
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
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594030
- Sponsor's protocol ID
- MD 03/2022
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Fluid Content by Electric Bioimpedance Versus Lung Ultrasound in Preterm Neonates With Respiratory Distress
- ClinicalTrials.gov ID
- NCT05594030
- Acronym / sponsor ID
- MD 03/2022
- Conditions
- Respiratory Distress Syndrome, Newborn
- Keywords
- preterm, respiratory distress, LUS, TFC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 minute to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm neonates admitted to Ain shams University Hospital NICUs fulfilling the inclusion criteria
Key inclusion criteria (3 listed)
- Preterm neonates with gestational age ≤ 34 weeks, admitted with respiratory distress:
- Tachypnea, grunting, retractions (subcostal, intercostal, suprasternal), nasal flaring and other symptoms include apnea, bradypnea, irregular (seesaw) breathing, inspiratory stridor, wheezes and hypoxia
Key exclusion criteria (2 listed)
- Preterm neonates with evidence of any of the following:
- Chromosomal anomalies Mechanical ventilation or received endotracheal surfactant before first assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 72 hours
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
1 secondary outcome
TFC parameters may offer the ability to monitor lung fluid content and provide longitudinal follow-up during interventions and disease processes.
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Newborn, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed Khalifa, MD (01010736078 ext. 202, drkhalifa2233@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.