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Assessing the likelihood of needing a substance called surfactant for newborns born near their expected delivery date using lung ultrasound

Quantitative lung ultrasound to predict surfactant need in late preterm and term neonates with respiratory failure

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN18610513
Enrollment
142
Registered
2024-01-02
Start date
2022-12-01
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surfactant need in late preterm and term infants Pregnancy and Childbirth

Interventions

Calculation of the lung ultrasound scores performed upon NICU admission and before surfactant administration (if any) together with the consideration of data issued of vital monitoring. Ultrasound and

Sponsors

APHP-Paris Saclay University DMU2
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Contacts

Public ContactDaniele De Luca
daniele.deluca@aphp.fr+33 145374837

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026