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

NCT01517958 | Completed DMC

• 2 other identifiers: GCO 11-0598IF#1289354
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Transient tachypnea of the newborn; Respiratory Distress Syndrome; Lung Ultrasound; Neonates

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Respiratory Distress Group

Neonates 28 weeks GA or greater with respiratory distress

Other: Respiratory Distress Group

Control Group

Neonates 28 weeks GA or greater without respiratory distress.

Other: Control Group

Interventions

Respiratory Distress Group OTHER

Diagnostic lung ultrasound.

Also known as: Diagnostic lung ultrasound.

Respiratory Distress Group

Control Group OTHER

Lung ultrasound

Control Group

Eligibility Criteria

• Age: 28 Weeks+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Transient Tachypnea of the Newborn; Respiratory Distress Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ian Holzman, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: January 25, 2012
• Study Start: October 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 25, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)