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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01517958
First received: January 20, 2012
Last updated: March 24, 2016
Last verified: March 2016

January 20, 2012
March 24, 2016
October 2011
June 2013   (final data collection date for primary outcome measure)
lung ultrasound [ Time Frame: within first 24 hours of life. ] [ Designated as safety issue: No ]

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.

Same as current
Complete list of historical versions of study NCT01517958 on ClinicalTrials.gov Archive Site
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Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates
The Use of Lung Ultrasound to Diagnose RDS vs. TTN in Neonates Greater Than or Equal to 28 Weeks Gestation
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
Neonatal patients admitted to Mount Sinai NICU of gestational age greater than or equal to 28 weeks.
  • Transient Tachypnea of the Newborn
  • TTN
  • Respiratory Distress Syndrome
  • RDS
  • Other: Respiratory Distress Group
    Diagnostic lung ultrasound.
    Other Name: Diagnostic lung ultrasound.
  • Other: Control Group
    Lung ultrasound
  • Respiratory Distress Group
    Neonates 28 weeks GA or greater with respiratory distress
    Intervention: Other: Respiratory Distress Group
  • Control Group
    Neonates 28 weeks GA or greater without respiratory distress.
    Intervention: Other: Control Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
June 2013
June 2013   (final data collection date for primary outcome measure)

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).
Both
28 Weeks and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01517958
GCO 11-0598, IF#1289354
Yes
No
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Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
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Principal Investigator: Ian Holzman, MD Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP