Lung Ultrasound to Diagnose Transient Tachypnea of the Newborn (TTN) Versus Respiratory Distress Syndrome (RDS) in Neonates
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Purpose
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 | Intervention |
|---|---|
|
Transient Tachypnea of the Newborn TTN Respiratory Distress Syndrome RDS |
Other: Respiratory Distress Group Other: Control Group |
| Study Type: | Observational |
| Study Design: | 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 |
- 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.
| Estimated Enrollment: | 32 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 28 Weeks and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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).
Contacts and Locations| Contact: Claudia Cadet, MD | 212-241-6186 |
| United States, New York | |
| Mount Sinai Medical Center | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Claudia Cadet, MD 212-241-6186 claudia.cadet@mssm.edu | |
| Principal Investigator: Ian Holzman, MD | |
| Sub-Investigator: Claudia Cadet, MD | |
| Principal Investigator: | Ian Holzman, MD | Mount Sinai School of Medicine |
More Information
No publications provided
| Responsible Party: | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01517958 History of Changes |
| Other Study ID Numbers: | GCO 11-0598, IF#1289354 |
| Study First Received: | January 20, 2012 |
| Last Updated: | December 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mount Sinai School of Medicine:
|
Transient tachypnea of the newborn Respiratory Distress Syndrome Lung Ultrasound Neonates |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on May 23, 2013