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 | Completed

• 1 other identifier: TERNOY-LANZINI 2022
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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)

Conditions

Neonatal Respiratory Distress; Preterm Birth

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Premature infants

premature infants born between 32 and 36 weeks of amenorrhea + 6 days hospitalized for respiratory distress

Procedure: Pulmonary ultrasound

Interventions

Pulmonary ultrasound PROCEDURE

Within 6 hours of admission to Neonatal Pediatrics and Intensive Care

Premature infants

Eligibility Criteria

• Age: 0 Hours - 2 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Premature infants

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Conditions

Pulmonary Atelectasis; Premature Birth

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 21, 2023
• Study Start: November 27, 2022
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)