Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates

Respiratory Distress Syndrome Clinical Trial

Official title:

The Use of Lung Ultrasound to Diagnose RDS vs. TTN in Neonates Greater Than or Equal to 28 Weeks Gestation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517958
• Other study ID #: GCO 11-0598
• Secondary ID: IF#1289354
• Status: Completed
• Phase: N/A
• First received: January 20, 2012
• Last updated: March 24, 2016
• Start date: October 2011
• Est. completion date: June 2013

Study information

• Verified date: March 2016
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The investigators hypothesize that ultrasonography of the newborn lung can be used as an effective diagnostic tool in neonates ≥ 28 weeks gestation with early symptoms of respiratory distress.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 28 Weeks and older

Eligibility

Inclusion Criteria:

• gestational age = 28 weeks

• symptoms of respiratory distress defined as:

• tachypnea (respiratory rate > 60 breaths per minute)

• FiO2 requirement >21%

• intercostal/subcostal retractions

• grunting and/or nasal flaring

• If clinically warranted, a chest x-ray will be done as part of the workup for respiratory distress; these patients with CXR will be included in the study.

• Inclusion criteria for the control group will be gestational age = 28 weeks with no symptoms of respiratory distress (defined above).

Exclusion Criteria:

• neonates with prenatally diagnosed structural cardiac disease

• major multiple congenital anomalies

• other causes of respiratory distress that are not RDS or TTN (e.g. pneumothorax, CCAM or pneumonia).

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• RDS
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Tachypnea
• Transient Tachypnea of the Newborn
• TTN

Intervention

Other:
• Respiratory Distress Group
Diagnostic lung ultrasound.
• Control Group
Lung ultrasound

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lung ultrasound	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.	within first 24 hours of life.	No