Additional lung ultrasound to estimate the need for respiratory support in term and near-term newborns with respiratory distress

• Conditions: P22.9; Respiratory distress of newborn, unspecified

• Registration Number: DRKS00020520
• Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-17
• Study Completion: 2022-06-30
• Results First Posted: 2024-08-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Term and late preterm infants with a gestational age = 36 + 0 /7 weeks)

Signs and symptoms of respiratory distress: respiratory rate > 60/min, expiratory grunting, nasal flaring, intercostal or subcostal retractions, cyanosis, requirement of supplemental oxygen

Onset of respiratory distress within 30 minutes after birth

Respiratory support via continuous positive airway pressure

Exclusion Criteria

Severe congenital disease (chromosomal abnormality, structural heart defect, congenital lung malformations, abdominal wall defect, neuromuscular disorder)

diagnosis of an early-onset sepsis or pneumonia (elevated inflammatory markers and start of antibiotic therapy)

diagnosis of a respiratory distress syndrome due to surfactant deficiency (need for surfactant application)

diagnosis of meconium aspiration syndrome

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of respiratory support via continuous positive airway pressure<br>

Secondary Outcome Measures

Name	Time	Method
Duration of inpatient stay in the intensive care unit.<br><br>Description of the correlation between ultrasound findings, clinical and laboratory parameters and the duration of respiratory support via continuous positive airway pressure (development of a scoring system).<br><br>Evaluation of interobserver variability in the assessment of the ultrasound findings.<br>