Surfactant need in late preterm and term infants Pregnancy and Childbirth
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All late preterm and term (>=34 weeks' gestation) neonates admitted to the NICU in the first 72 h of life with respiratory failure
Exclusion criteria
Exclusion criteria: 1. Major congenital malformations or chromosomopathies 2. Airleaks preventing a comprehensive lung ultrasound examination 3. Early onset sepsis and hemodynamic instability (defined as need for any inotrope) 4. Congenital surfactant anomalies 5. Pulmonary hypoplasia or congenital lung malformations 6. PPHN 7. Need for surgery in the first week of life
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Upon NICU admission and before surfactant administration (if any): 1. Diagnostic accuracy measures (area under the ROC curve and derived accuracy variables). For these outcomes, lung ultrasound scores and need for surfactant replacement will be collected (i.e.: this will allow the raw calculation of true and false positives and negatives). 2. Additionally demographics, clinical and monitoring variables usually registered during routine care will be collected. | — |
Secondary
| Measure | Time frame |
|---|---|
| Oxygenation metrics measured with usual vital monitoring available in each center and its relationship with lung ultrasound score measured using patient records upon NICU admission and before surfactant administration (if any) | — |
Countries
France, Italy, Spain, United States of America