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

Completed

• Conditions: Neonatal Respiratory Distress; Preterm Birth
• Interventions: Procedure: Pulmonary ultrasound

• Registration Number: NCT05737095
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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 available

Study Timeline

• Study Start: 2022-11-27
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-02-21
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Premature infants	Pulmonary ultrasound	premature infants born between 32 and 36 weeks of amenorrhea + 6 days hospitalized for respiratory distress

Primary Outcome Measures

Name	Time	Method
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	Number of infants receiving a lung ultrasound within 6 hours of admission divided by the number of infants meeting the inclusion criteria

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France