Study of the Feasibility of Early Lung Ultrasound in Neonatal Respiratory Distress in Premature Newborns Born Between 32 Weeks of Amenorrhea and 36 Weeks Plus 6 Days of Amenorrhea, Hospitalized in the Neonatal Pediatrics and Intensive Care Units of the Dijon University Hospital (REchoPP)

February 20, 2023 updated by: Centre Hospitalier Universitaire Dijon

Monocentric study carried out in the Neonatal and Intensive Care Units of the Dijon University Hospital.

The objective is to evaluate the feasibility of performing a pulmonary ultrasound within 6 hours after admission in premature infants born between 32 weeks of amenorrhea and 36 weeks of amenorrhea + 6 days who are hospitalized for initial respiratory distress.

Pulmonary ultrasound is performed within 6 hours of admission and an ultrasound score is calculated according to the images observed.

Continued management according to protocols without taking into account the ultrasound data.

Follow-up of patients until discharge from hospital or D28 of life (whichever comes first)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

104

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

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 2 hours (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Premature infants

Description

Inclusion Criteria:

  • Verbal consent from at least one legal guardian
  • Premature infant (between 32 weeks of amenorrhea and 36 weeks of amenorrhea + 6 days) admitted for neonatal respiratory distress that began in the first 2 hours of life
  • Hospitalized at the Dijon University Hospital in the Neonatal Pediatrics and Intensive Care Units

Exclusion Criteria:

  • individual is not affiliated to the national health care system
  • major intrathoracic or abdominal malformation

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Premature infants
premature infants born between 32 and 36 weeks of amenorrhea + 6 days hospitalized for respiratory distress
Procedure: Pulmonary ultrasound
Within 6 hours of admission to Neonatal Pediatrics and Intensive Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of infants receiving a lung ultrasound within 6 hours of admission divided by the number of infants meeting the inclusion criteria
Time Frame: Within 6 hours of admission
Number of infants receiving a lung ultrasound within 6 hours of admission divided by the number of infants meeting the inclusion criteria
Within 6 hours of admission

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

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 27, 2022

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Estimate)

February 21, 2023

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TERNOY-LANZINI 2022

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.

Clinical Trials on Preterm Birth

Clinical Trials on Pulmonary ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe