Study of the Feasibility of Early Lung Ultrasound in Neon... | NCT05737095

Studies
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

NCT05737095

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Feb 24, 2025Actual

Enrollment

69Actual

Phase

Not provided

Conditions

Neonatal Respiratory Distress
Preterm Birth

Interventions

Pulmonary ultrasound

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Brief Title

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

Official Title

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 27, 2022Actual

Primary Completion Date

Dec 20, 2024Actual

Completion Date

Dec 20, 2024Actual

First Submitted Date

Feb 8, 2023

First Submission Date that Met QC Criteria

Feb 20, 2023

First Posted Date

Feb 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2025

Last Update Posted Date

Feb 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Premature infants		premature infants born between 32 and 36 weeks of amenorrhea + 6 days hospitalized for respiratory distress	Procedure: Pulmonary ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary ultrasound	Procedure	Within 6 hours of admission to Neonatal Pediatrics and Intensive Care	Premature infants

Outcomes Module

Primary Outcomes

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	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Hours

Maximum Age

2 Hours

Standard Ages

Child

Study Population

Premature infants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Dijon Bourgogne		Dijon		21000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D001261	Pulmonary Atelectasis
D047928	Premature Birth

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases