REchoPP: 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

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05737095
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Anticipated Duration (Months): 36.1
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Neonatal Respiratory Distress; Preterm Birth	Procedure: Pulmonary ultrasound

Study Design

• Study Type: Observational
• Anticipated Enrollment: 104 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official 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
• Actual Study Start Date: Nov 27, 2022
• Anticipated Primary Completion Date: Nov 1, 2024
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Hours to 2 Hours
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Dijon Bourgogne	Dijon		France	21000

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT05737095
• Other Study ID Numbers: TERNOY-LANZINI 2022
• First Posted: Feb 21, 2023
• Last Update Posted: Feb 21, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Premature Birth; Amenorrhea

Study Results

No Results Posted as of Feb 21, 2023