Status:
TERMINATED
Lung UltrasouNd Guided Surfactant Therapy in Preterm Infants (LUNG Study)
Lead Sponsor:
Azienda Ospedaliero-Universitaria Careggi
Conditions:
Respiratory Distress Syndrome, Newborn
Eligibility:
All Genders
1-3 years
Phase:
NA
Brief Summary
The investigators hypothesized that the use of lung ultrasound (LU) for measuring RDS severity and deciding surfactant treatment thresholds might decrease the incidence of early and late sequelae in t...
Detailed Description
Background Management of neonatal respiratory distress syndrome (RDS) involves noninvasive respiratory supports, such as nasal continuous positive airway (nCPAP), and mechanical ventilation. On the ot...
Eligibility Criteria
Inclusion
- In-born infants at 25+0-29+6 weeks of gestational age
- Spontaneously breathing at birth but requiring noninvasive respiratory support with nCPAP at a pressure of 6-8 cmH2O to maintain an SpO2 between 90% and 95%.
- Parental consent has been obtained
- Exclusion of causes of respiratory failure other than RDS
Exclusion
- Endotracheal intubation in the delivery room for resuscitation or insufficient respiratory drive according to European guidelines
- Prolonged premature rupture of membranes (PROM) for more than 3 days
- Presence of major congenital malformations or chromosomal anomalies
- Hydrops fetalis
- Inherited disorders of metabolism
- Administration of surfactant before performing the LUS.
- Other respiratory diseases than RDS
Key Trial Info
Start Date :
April 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2025
Estimated Enrollment :
411 Patients enrolled
Trial Details
Trial ID
NCT05198375
Start Date
April 5 2022
End Date
May 23 2025
Last Update
May 29 2025
Active Locations (18)
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1
Neonatal intensive care unit - Azienda Sanitaria dell'Alto Adige
Bolzano, Italy
2
Spedali Civili di Brescia
Brescia, Italy
3
AOU Careggi
Florence, Italy, 50134
4
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano
Milan, Italy