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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome; Transient Tachypnea of the Newborn; RDS; TTN
• Intervention / Treatment: 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
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • ICAHN School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neonatal patients admitted to Mount Sinai NICU of gestational age greater than or equal to 28 weeks.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Respiratory Distress Group; Neonates 28 weeks GA or greater with respiratory distress	Other: Respiratory Distress Group; Diagnostic lung ultrasound.; Other Names: Diagnostic lung ultrasound.
Control Group; Neonates 28 weeks GA or greater without respiratory distress.	Other: Control Group; Lung ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Ian Holzman, MD, ICAHN School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: January 20, 2012
• First Submitted That Met QC Criteria: January 24, 2012
• First Posted (Estimate): January 25, 2012

Study Record Updates

• Last Update Posted (Estimate): March 25, 2016
• Last Update Submitted That Met QC Criteria: March 24, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Neonates; Respiratory Distress Syndrome; Transient tachypnea of the newborn; Lung Ultrasound
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Tachypnea; Transient Tachypnea of the Newborn
• Other Study ID Numbers: GCO 11-0598; IF#1289354

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No