Assessing the likelihood of needing a substance called surfactant for newborns born near their expected delivery date using lung ultrasound
Not Applicable
Completed
- Conditions
- Surfactant need in late preterm and term infantsPregnancy and Childbirth
- Registration Number
- ISRCTN18610513
- Lead Sponsor
- APHP-Paris Saclay University DMU2
- Brief Summary
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38805223/ (added 14/06/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 157
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pon NICU admission and before surfactant administration (if any):<br>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).<br>2. Additionally demographics, clinical and monitoring variables usually registered during routine care will be collected.
- Secondary Outcome Measures
Name Time Method 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)