The Role of Lung Ultrasonography Score in Predicting Prognosis in Term and Late Preterm Newborns With Postnatal Respiratory Distress (TeLaPLUS)

July 12, 2024 updated by: Bayram Ali DORUM, Bursa City Hospital
Respiratory distress in term and late preterm infants in the first hour after birth is a prevalent condition. This situation may occur due to different reasons such as minimal respiratory stress, transient tachypnea of newborn, respiratory distress syndrome, and congenital pneumonia. It can be not easy to distinguish this in the first hours. This study aimed to investigate the place of the lung ultrasonography score in the prognosis of these patients.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

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 Contact Backup

Study Locations

  • Turkey
      • Bursa, Turkey
        • Recruiting
        • Bursa City Hospital
        • Contact:
        • Sub-Investigator:
          • Ayten Erdogan Ordu
        • Sub-Investigator:
          • Bensu Zadeoglu

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

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Term and late-preterm premature newborns with respiratory distress symptoms in the first 30 minutes after birth

Description

Inclusion Criteria:

  • Having symptoms of respiratory distress that begin soon after birth,
  • > 34 gestational age,
  • >1900 gr birth weight,
  • Family consent

Exclusion Criteria:

  • Congenital anomaly
  • Chromosomal anomaly
  • Hydrops fetalis
  • Congenital heart disease

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Enrollment of a targeted number of patients
Time Frame: 4 months
4 months

Collaborators and Investigators

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

Sponsor

Bursa City Hospital

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)

November 11, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

September 2, 2023

First Submitted That Met QC Criteria

September 2, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

July 15, 2024

Last Update Submitted That Met QC Criteria

July 12, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCH-2023-14/2

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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