Neonatologist-performed Lung Ultrasound in the Delivery Room
NCT ID: NCT06408480
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2024-05-01
2025-05-31
Brief Summary
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Detailed Description
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Neonates born by a Caesarean section are particularly prone to have an altered adaption to extrauterine life. Especially in the first hours after birth, respiratory distress syndromes (RDS) may occur due to delayed lung fluid clearance after birth.
While acute RDS in the first hours after birth may be a self-limiting disorder and therefore a benign condition, it remains difficult to identify neonates in need for further respiratory support at the NICU. Admission to the NICU not only causes parental stress but also contributes to additional healthcare costs.
There is emerging evidence that NPLUS is a reliable tool to differentiate between the causes leading to RDS in neonates. Using a neonatologist performed lung ultrasound score for the early identification of neonates in need of respiratory support persisting more than 1 hour would be therefore highly advantageous.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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need of respiratory support > 60 min after birth
Group comprises neonates in need of further respiratory support more than 60 minutes after birth.
Neonatologist-performed lung ultrasound
lung ultrasound conducted in min 5, 15, 30, 60 min after birth in late preterm and term infants
need of respiratory support < 60 min after birth
Group comprises neonates that show any signs of respiratory distress in the first 60 minutes, but do not need respiratory support more than 60 minutes after birth.
Neonatologist-performed lung ultrasound
lung ultrasound conducted in min 5, 15, 30, 60 min after birth in late preterm and term infants
Interventions
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Neonatologist-performed lung ultrasound
lung ultrasound conducted in min 5, 15, 30, 60 min after birth in late preterm and term infants
Eligibility Criteria
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Inclusion Criteria
* Presence of any sign of respiratory distress (defined as tachypnoea/ dyspnoea, grunting, flaring of the nostrils or chest retractions)
* Written informed consent obtained from the parents prior to birth.
Exclusion Criteria
* Patients with pneumothorax diagnosed by neonatologist-performed lung ultrasound
60 Minutes
ALL
No
Sponsors
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Medical University of Graz
OTHER
Responsible Party
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Principal Investigators
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Bernhard Schwaberger, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Division of Neonatology, Medical University of Graz, Austria
Locations
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Division Neonatology, Dp. Pediatrics
Graz, Styria, Austria
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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36-150 ex 23/24
Identifier Type: -
Identifier Source: org_study_id
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