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

NCT ID: NCT01517958

Last Updated: 2016-03-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-06-30

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.

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.

Conditions

Transient Tachypnea of the Newborn; TTN; Respiratory Distress Syndrome; RDS

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Respiratory Distress Group

Neonates 28 weeks GA or greater with respiratory distress

Respiratory Distress Group

Intervention Type: OTHER

Diagnostic lung ultrasound.

Control Group

Neonates 28 weeks GA or greater without respiratory distress.

Control Group

Intervention Type: OTHER

Lung ultrasound

Interventions

Respiratory Distress Group

Diagnostic lung ultrasound.

Intervention Type: OTHER

Control Group

Lung ultrasound

Intervention Type: OTHER

Other Intervention Names

Diagnostic lung ultrasound.

Eligibility Criteria

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.

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).

• Minimum Eligible Age: 28 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian Holzman, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

IF#1289354

Identifier Type: -

Identifier Source: secondary_id

GCO 11-0598

Identifier Type: -

Identifier Source: org_study_id