Lung Ultrasound for Neonatal Respiratory Distress Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if lung ultrasound can diagnose severe breathing problems more quickly in newborns. The goal is to expedite treatment for babies born between 27 and 34 weeks who experience breathing difficulties but breathe independently. Researchers hope that ultrasound use will reduce the need for mechanical breathing assistance and decrease oxygen requirements. Babies who breathe on their own but need some support and show signs of respiratory distress are suitable candidates for this study. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance newborn care.
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications.
What prior data suggests that lung ultrasound is safe for neonatal respiratory distress syndrome?
Previous studies have shown that lung ultrasound is a safe and reliable tool for examining newborns with breathing problems. Research indicates that this method effectively checks the lungs without causing harm. It has proven highly accurate, correctly identifying those with the condition 92% to 99% of the time and those without it 95% to 97% of the time. Thus, lung ultrasound can accurately diagnose breathing issues in newborns most of the time.
Overall, evidence suggests that lung ultrasound is well-tolerated and safe for infants. No significant reports of negative effects have emerged from using this technique. This safety record makes lung ultrasound a valuable tool for quickly diagnosing and treating newborns with severe breathing issues.12345Why are researchers excited about this trial?
Researchers are excited about using lung ultrasound (LUS) for neonatal respiratory distress syndrome because it offers a non-invasive, real-time method to evaluate lung health in newborns. Unlike the standard of care, which relies on chest x-rays and blood gas tests, LUS provides immediate feedback without radiation exposure. This technique can guide timely surfactant administration based on a specific LUS score, potentially improving outcomes for premature infants by quickly addressing respiratory issues. By offering a safer and faster diagnostic tool, LUS could transform how clinicians assess and treat respiratory distress in neonates.
What evidence suggests that lung ultrasound is effective for diagnosing neonatal respiratory distress syndrome?
Research has shown that lung ultrasound (LUS), which participants in this trial may receive, effectively diagnoses breathing problems in newborns, known as neonatal respiratory distress syndrome (NRDS). Studies indicate that LUS can correctly identify up to 98.4% of newborns with the condition and 100% of those without it, accurately detecting breathing issues in babies. LUS results can also help predict if a newborn will need surfactant therapy, which aids in breathing. Using LUS can lead to faster and more accurate treatment for NRDS, potentially improving short-term breathing outcomes.12678
Who Is on the Research Team?
Sandy Cheung, DO
Principal Investigator
Hackensack Meridian Health
Are You a Good Fit for This Trial?
This trial is for newborns born between 27 and almost 35 weeks of pregnancy who are breathing on their own but need non-invasive help to breathe, and either have or are at risk for respiratory distress syndrome (RDS).Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lung Ultrasound Assessment
Lung ultrasound is performed within 2 hours of life to assess severity of RDS and determine eligibility for surfactant treatment
Treatment
Surfactant administration via LISA method based on lung ultrasound score
Follow-up
Participants are monitored for respiratory outcomes, need for mechanical ventilation, and duration of respiratory support
What Are the Treatments Tested in This Trial?
Interventions
- Lung Ultrasound
Trial Overview
The study compares using a lung ultrasound score versus standard care to decide when to give surfactant treatment in preterm infants with RDS. The goal is to see if the ultrasound approach leads to faster diagnosis and better short-term breathing outcomes.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The lung ultrasound will be performed within 2 hours of life scanning 6 anatomic lung zones. The lung ultrasound (LUS) score will be calculated in a longitudinal and transverse scan by dividing each lung into 3 different areas: upper-anterior, lower-anterior, and lateral. Every lung section will be scored 0-3 points. The total LUS score will range from 0 to 18 points according to the severity of the lung pattern. Examinations will be performed in the supine position. Lung ultrasound scores will be performed by neonatologist-researchers. A LUS score of 6 in \< 28 week gestation and 8 in \> 28 week gestation is the cut-off for initiating surfactant treatment. If the LUS score is \> 6 in neonates \< 28 weeks gestation, or \> 8 in those \> 28 weeks gestation, surfactant treatment will be administered. If a neonate in the LUS group does not meet criteria for SRT based on the lung ultrasound score, SRT may be administered per the clinician's discretion at any time.
The standard of care group may have surfactant administered per clinician discretion. Standard diagnostic testing including CXR and blood gas will be performed per SOC. Current accepted practice in the NICU is to utilize a composite of chest x-ray interpretation, assessment of work of breathing, degree of respiratory support and FiO2 requirement (typically Fi02 35%) to guide SRT.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hackensack Meridian Health
Lead Sponsor
Citations
Lung Ultrasound in Neonatal Respiratory Distress Syndrome
This narrative review aims to evaluate the role of LUS in the diagnosis and management of neonatal RDS over the past decade.
The value of lung ultrasound score in neonatal respiratory ...
The accurate diagnosis of critically ill patients with respiratory failure can be achieved through lung ultrasound (LUS) score.
Lung ultrasonography in the management of preterm (≤34 ...
The results showed that LUS had sensitivity and specificity of 98.4% and 100%, respectively, in diagnosing respiratory distress. The PPV for RDS on LUS was 96.6 ...
Current Trends in the Imaging Diagnosis of Neonatal ... - PMC
The study found that LUS demonstrated a sensitivity of 95.6% and a specificity of 94.4% for diagnosing NRDS, with a positive predictive value ( ...
The efficacy of lung ultrasound scores-directed pulmonary ...
Recent studies suggest that LUS scores can help predict the need for surfactant therapy and optimize respiratory support settings, offering a more personalized ...
Prognostic Relevance of the Lung Ultrasound Score - PMC - NIH
In conclusion, our results showed significant predictive value of the LUS in the first week of life with regard to critical outcomes in neonatal RDS. The ...
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journals.lww.com
journals.lww.com/ultrasound-quarterly/fulltext/2020/06000/lung_ultrasound_for_the_diagnosis_of_neonatal.3.aspxLung Ultrasound for the Diagnosis of Neonatal Respiratory...
Some studies have shown that lung ultrasound (LUS) is helpful in the diagnosis of NRDS. A comprehensive search was carried out using PubMed, Embase, and the ...
Lung Sonar in Neonatal Respiratory Disorders
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 ...
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