Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01517958|
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : March 25, 2016
|Condition or disease||Intervention/treatment|
|Transient Tachypnea of the Newborn TTN Respiratory Distress Syndrome RDS||Other: Respiratory Distress Group Other: Control Group|
Respiratory distress is a common reason for admission to the neonatal intensive care unit (NICU) for both preterm and full term newborns. TTN and RDS are the two most common diagnoses associated with respiratory distress. Due to their similar clinical presentations, it is often difficult to differentiate the two diseases clinically. Currently chest radiography is used to differentiate between TTN and RDS, however, radiographic findings are not always definitively diagnostic.
In preliminary studies, lung ultrasonography has been shown to be a useful tool in diagnosing both TTN and RDS. However, no one has looked at the use of lung ultrasonography in differentiating TTN from RDS in the neonatal population. We propose to do so in this study.
Patients will be enrolled from neonatal admissions to the NICU with respiratory distress. Lung ultrasound will be performed on all enrolled subjects, looking for specific findings suggestive of either TTN or RDS. Data will be collected on gestational age, physical exam findings and level of respiratory support. Diagnoses will be recorded based on ultrasound findings. Accuracy of lung ultrasound diagnosis will be compared to that using radiographic chest radiography findings to evaluate if lung ultrasound is equivalent, or better than chest radiography in order to diagnose TTN versus RDS in this patient population.
|Study Type :||Observational|
|Actual Enrollment :||36 participants|
|Observational Model:||Case Control|
|Official Title:||The Use of Lung Ultrasound to Diagnose RDS vs. TTN in Neonates Greater Than or Equal to 28 Weeks Gestation|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Respiratory Distress Group
Neonates 28 weeks GA or greater with respiratory distress
Other: Respiratory Distress Group
Diagnostic lung ultrasound.
Other Name: Diagnostic lung ultrasound.
Neonates 28 weeks GA or greater without respiratory distress.
Other: Control Group
- lung ultrasound [ Time Frame: within first 24 hours of life. ]
The primary endpoint is to determine whether lung ultrasound is comparable or superior to chest radiography: (1) in making the diagnosis of RDS and TTN and (2) in differentiating between RDS and TTN.
Disease-specific lung ultrasound findings: (1) Double lung point in TTN and (2) lung white-out in RDS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517958
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Ian Holzman, MD||Icahn School of Medicine at Mount Sinai|