Neonatal Respiratory DistressNCT06292338
Lung Sonar in Neonatal Respiratory Disorders
An observational study of Neonatal Respiratory Distress, run by Gehad Adel Mohammed Hussein.
Trial summary
This study aimed to determine the value of chest ultrasonography in comparison to other tools as chest x-ray and ABG in diagnosis and follow up of neonates with respiratory disorders. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal Respiratory Distress
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 May 2025
- 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 day to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: All neonates (Term and preterm) presented with respiratory disorders
Who may be able to join
- neonates with a gestational age ≥28 weeks who are suffering from respiratory disorders.
Who cannot join
- neonates having multiple congenital anomalies, chromosomal aberrations, hydrops fetalis and/or heart failure.
About this study
Official title: A Comparative Study of Lung Ultrasound in Assessment of Neonatal Respiratory Disorders With Other Diagnostic Aids in NICU of Assuit University Children's Hospital
This study aimed to determine the value of chest ultrasonography in comparison to other tools as chest x-ray and ABG in diagnosis and follow up of neonates with respiratory disorders.
Read the detailed description
Respiratory distress is the most frequent cause of neonatal intensive care unit (NICU) admission, and the individual management strategies should be the main task in NICUs for these infants. Fifteen percent of term infants and twenty-nine percent of late preterm infants admitted to the NICU develop significant respiratory morbidity; this is even higher for infants born before 34 weeks' gestation. Neonatal respiratory distress syndrome (NRDS) is one of the most common causes of neonatal respiratory failure and neonatal mortality, especially in premature infants, who tend to have very low birth weight.NRDS is a pulmonary insufficiency caused by structural and functional immaturity of the lung. The incidence of NRDS depends upon gestational age and varies from 92% for infants born at 24-25 weeks to 57% for those born at 30-31 weeks.Mortality from NRDS varies according to the infants' weight, from 50% for infants of <1.0 kg to 0% for those of more than 4.0 kg.Infants affected by NRDS usually require pulmonary surfactant and continuous positive airway pressure (invasive ventilation or mechanical ventilation). Although chest X-Ray plays an important role in diagnosis of respiratory distressed neonates, it leads to their exposure to ionizing radiation due to their small size and the close proximity of radiosensitive tissues and organs are at greater risk from latent effects of chest Xray in comparison to other age groups. As chest x-ray (CXR) and/or chest computerized tomography (chest CT) are the main imaging tools in the diagnosis of lung diseases. For a long time, the lung ultrasound (LUS) was considered a "forbidden zone" in the diagnosis of lung diseases since ultrasonic waves are totally reflected when encountering air. However, by utilizing ultrasonic artefacts formed by different pathological changes in adults, children and poor newborn infants,this "forbidden zone" has been contested and point-of-care lung ultrasound (POC-LUS) has been successfully used for the diagnosis of lung diseases. Neonatal lung ultrasound (LUS) is used in emergent situations, differentiating neonatal respiratory pathologies, and predicting neonatal morbidity . LUS can be brought to the bedside of the fragile neonate, used serially, and does not expose the neonate to ionizing radiation.
Functional and descriptive applications make it a high-fidelity tool to aid in distinguishing the various causes of neonatal respiratory failure and to guide in management . LUS also has increased sensitivity and specificity in comparison with an X-ray for the detection of respiratory pathologies (e.g., TTN , RDS, pmeumothorax, and pleural effusion) and can be utilized to monitor progress of clinical pathologies.The neonatologist-performed LUS has the advantage of being immediately interpreted by those caring for the neonate, potentially leading to more accurate diagnosis and timely therapeutic as intervention. One of the most important applications is the recently proposed use of the LUS score as a semiquantitative assessment of the severity of lung diseases. Efforts have been made to determine the relationship between these scores and the diagnosis of the disease . This study aimed to evaluate the relationship between the LUS score and the diagnosis of neonates hospitalized because of respiratory disorder.
In this study, the investigators also aimed to evaluate the correlation between LUS scores and blood gas parameters in patients hospitalized for respiratory distress and to get an idea about the severity of the disease.Therefore, it can be used to predict the need for surfactants in preterm infants. Its positive role in predicting surfactant need in very- and extremely preterm newborns disease and also the development of chronic lung disease in preterm neonates has been reported recently . LUS scores obtained during the first days of life can provide information about the prognosis of neonatal respiratory failure and predict the need for respiratory support . In addition, LUS performs a useful role in predicting non-invasive ventilation failure in neonates with respiratory distress, and this is important for the clinician to decide to apply invasive mechanical ventilation to prevent clinical deterioration . Lung ultrasound has a prognostic value in monitoring and follow-up of lung development in preterm infants. and it is an adequate tool to predict the development of bronchopulmonary dysplasia (BPD)in infants born preterm before 32 weeks of gestation: for diagnosis of BPD from as early as 3 days post birth, although the optimal timing for its use is 1 week post birth .
The usual evolution of pulmonary patterns in neonates delivered before 32 weeks starts with a pattern characteristic of RDS at birth, with high LUS score values in the 1st days, but then normally improve thereafter as the primary surfactant deciency resolves, reaching LUS score values near 0 at around 1 week post birth.The patients whose LUS scores do not exhibit this decrease or actually increase are more likely to develop BPD.
- Conditions
- Neonatal Respiratory Distress
- Keywords
- LUS, Neonates, Respiratory disorders
- Medical subject headings
- Pulmonary Atelectasis, Respiration Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing between LUS and Chest xRay in neonatal respiratory disorders assessment
Our study aimed to evaluate the relationship between the LUS score and the diagnosis of neonates hospitalized because of respiratory disorder.
In our study, we also aimed to evaluate the correlation between LUS scores and blood gas parameters in patients hospitalized for respiratory distress and to get an idea about the severity of the disease.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory DistressStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gehad Adel Mohammed Hussein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gehad Adel Mohammed Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292338
- Sponsor's protocol ID
- AUCHAU
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2024
- Last updated
- 5 Mar 2024
- 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 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Lung Ultrasound in Assessment of Neonatal Respiratory Disorders With Other Diagnostic Aids in NICU of Assuit University Children's Hospital
- ClinicalTrials.gov ID
- NCT06292338
- Acronym / sponsor ID
- AUCHAU
- Conditions
- Neonatal Respiratory Distress
- Keywords
- LUS, Neonates, Respiratory disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Gehad Adel Mohammed HusseinUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 5 Mar 2024 (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.
This study aimed to determine the value of chest ultrasonography in comparison to other tools as chest x-ray and ABG in diagnosis and follow up of neonates with respiratory disorders.
Detailed description
Respiratory distress is the most frequent cause of neonatal intensive care unit (NICU) admission, and the individual management strategies should be the main task in NICUs for these infants. Fifteen percent of term infants and twenty-nine percent of late preterm infants admitted to the NICU develop significant respiratory morbidity; this is even higher for infants born before 34 weeks' gestation. Neonatal respiratory distress syndrome (NRDS) is one of the most common causes of neonatal respiratory failure and neonatal mortality, especially in premature infants, who tend to have very low birth weight.NRDS is a pulmonary insufficiency caused by structural and functional immaturity of the lung. The incidence of NRDS depends upon gestational age and varies from 92% for infants born at 24-25 weeks to 57% for those born at 30-31 weeks.Mortality from NRDS varies according to the infants' weight, from 50% for infants of <1.0 kg to 0% for those of more than 4.0 kg.Infants affected by NRDS usually require pulmonary surfactant and continuous positive airway pressure (invasive ventilation or mechanical ventilation). Although chest X-Ray plays an important role in diagnosis of respiratory distressed neonates, it leads to their exposure to ionizing radiation due to their small size and the close proximity of radiosensitive tissues and organs are at greater risk from latent effects of chest Xray in comparison to other age groups. As chest x-ray (CXR) and/or chest computerized tomography (chest CT) are the main imaging tools in the diagnosis of lung diseases. For a long time, the lung ultrasound (LUS) was considered a "forbidden zone" in the diagnosis of lung diseases since ultrasonic waves are totally reflected when encountering air. However, by utilizing ultrasonic artefacts formed by different pathological changes in adults, children and poor newborn infants,this "forbidden zone" has been contested and point-of-care lung ultrasound (POC-LUS) has been successfully used for the diagnosis of lung diseases. Neonatal lung ultrasound (LUS) is used in emergent situations, differentiating neonatal respiratory pathologies, and predicting neonatal morbidity . LUS can be brought to the bedside of the fragile neonate, used serially, and does not expose the neonate to ionizing radiation.
Functional and descriptive applications make it a high-fidelity tool to aid in distinguishing the various causes of neonatal respiratory failure and to guide in management . LUS also has increased sensitivity and specificity in comparison with an X-ray for the detection of respiratory pathologies (e.g., TTN , RDS, pmeumothorax, and pleural effusion) and can be utilized to monitor progress of clinical pathologies.The neonatologist-performed LUS has the advantage of being immediately interpreted by those caring for the neonate, potentially leading to more accurate diagnosis and timely therapeutic as intervention. One of the most important applications is the recently proposed use of the LUS score as a semiquantitative assessment of the severity of lung diseases. Efforts have been made to determine the relationship between these scores and the diagnosis of the disease . This study aimed to evaluate the relationship between the LUS score and the diagnosis of neonates hospitalized because of respiratory disorder.
In this study, the investigators also aimed to evaluate the correlation between LUS scores and blood gas parameters in patients hospitalized for respiratory distress and to get an idea about the severity of the disease.Therefore, it can be used to predict the need for surfactants in preterm infants. Its positive role in predicting surfactant need in very- and extremely preterm newborns disease and also the development of chronic lung disease in preterm neonates has been reported recently . LUS scores obtained during the first days of life can provide information about the prognosis of neonatal respiratory failure and predict the need for respiratory support . In addition, LUS performs a useful role in predicting non-invasive ventilation failure in neonates with respiratory distress, and this is important for the clinician to decide to apply invasive mechanical ventilation to prevent clinical deterioration . Lung ultrasound has a prognostic value in monitoring and follow-up of lung development in preterm infants. and it is an adequate tool to predict the development of bronchopulmonary dysplasia (BPD)in infants born preterm before 32 weeks of gestation: for diagnosis of BPD from as early as 3 days post birth, although the optimal timing for its use is 1 week post birth .
The usual evolution of pulmonary patterns in neonates delivered before 32 weeks starts with a pattern characteristic of RDS at birth, with high LUS score values in the 1st days, but then normally improve thereafter as the primary surfactant deciency resolves, reaching LUS score values near 0 at around 1 week post birth.The patients whose LUS scores do not exhibit this decrease or actually increase are more likely to develop BPD.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All neonates (Term and preterm) presented with respiratory disorders
Key inclusion criteria (1 listed)
- neonates with a gestational age ≥28 weeks who are suffering from respiratory disorders.
Key exclusion criteria (1 listed)
- neonates having multiple congenital anomalies, chromosomal aberrations, hydrops fetalis and/or heart failure.
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
Comparing between LUS and Chest xRay in neonatal respiratory disorders assessment
Time frame: 1 year
Our study aimed to evaluate the relationship between the LUS score and the diagnosis of neonates hospitalized because of respiratory disorder. In our study, we also aimed to evaluate the correlation between LUS scores and blood gas parameters in patients hospitalized for respiratory distress and to get an idea about the severity of the disease.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Respiratory Distress, run by Gehad Adel Mohammed Hussein.
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 1 inclusion and 1 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 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing between LUS and Chest xRay in neonatal respiratory disorders assessment (time frame: 1 year). 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 5 Mar 2024.