Diagnosis of Transient Tachypnea of Newborn

September 14, 2022 updated by: Ashraf Mohamed Ibrahim, Tanta University

Thoracic Fluid Content Using Electrical Cardiometry Versus Lung Ultrasound in the Diagnosis of Transient Tachypnea of Newborn

Transient tachypnea of the newborn (TTN) is the most common cause of respiratory distress in fullterm newborn. TTN is a diagnosis of exclusion, It is primarily diagnosed based on medical history and typical clinical presentation. Lung ultrasonography is an accurate, non invasive and reliable tool for diagnosing TTN. Cardiometry is presently the only tool to evaluate thoracic fluid content continuously and noninvasively at the bedside.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Tanta, Egypt, 31527
        • Recruiting
        • Tanta University, Faculty of Medicine
        • Contact:
        • Principal Investigator:
          • Nagwa Esmail
        • Sub-Investigator:
          • Heba Elmahdy
        • Sub-Investigator:
          • Manal Hamisa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 3 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

50 neonates diagnosed with Transient Tachypnea of Newborn admitted at Neonatal Intensive Care Unit, Tanta University Hospitals

Description

Inclusion Criteria:

  • fifty newborns with gestational age ≥ 34 weeks (calculated from the first day of last menstrual period and using New Ballard score) diagnosed with TTN

Exclusion Criteria:

  1. Gestational age less than 34 weeks.
  2. Major congenital abnormalities.
  3. Congenital heart diseases.
  4. Neonatal sepsis.
  5. Neonatal pneumonia.
  6. Other causes of respiratory distress (RD)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of thoracic fluid content
Time Frame: at enrollment and after 72 hours of birth
measured by electrical cardiometry ( ICON®; Osypka Medical, Berlin, Germany)
at enrollment and after 72 hours of birth
change of ultrasound data: double-lung point, interstitial lung syndrome, and fuzziness of the pleural lines (A-lines) and pleural effusion.
Time Frame: at enrollment and after 72 hours of birth
using Siemens Acuson X300 ultrasound machine ( Siemens Health Care GmbH, Erlangen, Germany )
at enrollment and after 72 hours of birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Study Director: ashraf abuhamama, Tanta University Faculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

September 9, 2022

First Submitted That Met QC Criteria

September 9, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 14, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 34987/10/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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