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. Identifier: NCT01517958
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : March 25, 2016
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief 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.

Condition or disease Intervention/treatment
Transient Tachypnea of the Newborn TTN Respiratory Distress Syndrome RDS Other: Respiratory Distress Group Other: Control Group

Detailed 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.

Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Case Control
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Respiratory Distress Group
Neonates 28 weeks GA or greater with respiratory distress
Other: Respiratory Distress Group
Diagnostic lung ultrasound.
Other Name: Diagnostic lung ultrasound.

Control Group
Neonates 28 weeks GA or greater without respiratory distress.
Other: Control Group
Lung ultrasound

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   28 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Neonatal patients admitted to Mount Sinai NICU of gestational age greater than or equal to 28 weeks.

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).

Information from the National Library of Medicine

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 identifier (NCT number): NCT01517958

United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Principal Investigator: Ian Holzman, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Icahn School of Medicine at Mount Sinai Identifier: NCT01517958     History of Changes
Other Study ID Numbers: GCO 11-0598
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
Transient tachypnea of the newborn
Respiratory Distress Syndrome
Lung Ultrasound

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Transient Tachypnea of the Newborn
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms