Preterm Birth Clinical Trial
— REchoPPOfficial 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
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)
Status | Recruiting |
Enrollment | 104 |
Est. completion date | December 2025 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Hours to 2 Hours |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Chu Dijon Bourgogne | Dijon |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Dijon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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