NCT06031324

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 11, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

September 2, 2023

Last Update Submit

July 12, 2024

Conditions

Respiratory Distress SyndromeLung Ultrasonography Score

Keywords

Respiratory distress syndromeLung ultrasonographyNewborn

Outcome Measures

Primary Outcomes (1)

  • Enrollment of a targeted number of patients

    4 months

Eligibility Criteria

Age30 Minutes - 120 Minutes
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa City Hospital

Bursa, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Central Study Contacts

Bayram Ali Dorum

CONTACT

+905337078398bayramalidorum@gmail.com

Ayten Erdoğan Ordu

CONTACT

aytenli21@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Neonatology

Study Record Dates

First Submitted

September 2, 2023

First Posted

September 11, 2023

Study Start

November 11, 2023

Primary Completion

December 31, 2024

Study Completion

February 28, 2025

Last Updated

July 15, 2024

Record last verified: 2024-07

Locations

TU(1)