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

Sponsor
Bursa City Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06031324
Collaborator
(none)
100
Enrollment
1
Location
5.6
Anticipated Duration (Months)
17.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Role of Lung Ultrasonography Score in Predicting Prognosis in Term and Late Preterm Newborns With Postnatal Respiratory Distress
    Anticipated Study Start Date :
    Sep 11, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Feb 28, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Enrollment of a targeted number of patients [4 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Minutes to 120 Minutes
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bursa City Hospital Bursa Turkey

    Sponsors and Collaborators

    • Bursa City Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bayram Ali DORUM, Associate Professor of Neonatology, Bursa City Hospital
    ClinicalTrials.gov Identifier:
    NCT06031324
    Other Study ID Numbers:
    • BCH-2023-14/2
    First Posted:
    Sep 11, 2023
    Last Update Posted:
    Sep 11, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bayram Ali DORUM, Associate Professor of Neonatology, Bursa City Hospital
    Respiratory distress syndrome
    Lung ultrasonography
    Newborn
    Additional relevant MeSH terms:
    Respiratory Distress Syndrome
    Respiratory Distress Syndrome, Newborn
    Tachypnea
    Transient Tachypnea of the Newborn

    Study Results

    No Results Posted as of Sep 11, 2023