Using lung ultrasound by neonatologists to assess newborns after birth
Neonatologist-performed Lung Ultrasound During Immediate Transition After Birth to Predict the Need for Respiratory Support Persisting More Than 1 Hour - a Pilot Study
Medical University of Graz · NCT06408480
This study is testing if using lung ultrasound right after birth can help doctors quickly identify which newborns might need extra breathing support, especially those born by C-section.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | N/A to 60 Minutes |
| Sex | All |
| Sponsor | Medical University of Graz (other) |
| Locations | 1 site (Graz, Styria) |
| Trial ID | NCT06408480 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of neonatologist-performed lung ultrasound (NPLUS) in assessing late preterm and full-term neonates immediately after birth. The focus is on using a lung ultrasound score to predict which infants may require respiratory support for more than one hour post-delivery. Given that neonates born via Caesarean section are at higher risk for respiratory distress, this approach aims to identify those needing further care in the NICU, potentially reducing unnecessary admissions and associated stress for families. The study is observational and aims to gather data on the utility of this emerging clinical tool in real-time settings.
Who should consider this trial
Good fit: Ideal candidates include late preterm and full-term neonates delivered by Caesarean section who show signs of respiratory distress.
Not a fit: Patients with existing cardiopulmonary malformations or diagnosed pneumothorax will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate assessments of respiratory needs in newborns, reducing unnecessary NICU admissions.
How similar studies have performed: Emerging evidence suggests that similar approaches using lung ultrasound in neonates have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Late preterm neonates (born between 34 0/7 and 36 6/7 weeks of gestation) and full-term neonates (born later than 36 6/7 weeks of gestation) delivered by Caesarean section * 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: * Presence of cardiopulmonary malformations * Patients with pneumothorax diagnosed by neonatologist-performed lung ultrasound
Where this trial is running
Graz, Styria
- Division Neonatology, Dp. Pediatrics — Graz, Styria, Austria (RECRUITING)
Study contacts
- Principal investigator: Bernhard Schwaberger, MD PhD — Division of Neonatology, Medical University of Graz, Austria
- Study coordinator: Bernhard Schwaberger, MD PhD
- Email: bernhard.schwaberger@medunigraz.at
- Phone: +4331638530018
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neonatal Disease, neonatologist-performed lung ultrasound, postnatal transition, neonates