Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06292338 |
Other study ID # |
AUCHAU |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 1, 2024 |
Est. completion date |
May 1, 2025 |
Study information
Verified date |
March 2024 |
Source |
Assiut University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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.
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.