Lung ultrasound score and variable respiratory support

Does lung ultrasound predict surfactant administration in neonates with respiratory distress stabilized with different support techniques? An international, pragmatic study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN10205806

Enrollment

220

Registered

2025-06-16

Start date

2024-05-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Accuracy of lung ultrasound score to predict surfactant administration in neonates with respiratory distress stabilized with different support techniques Respiratory

Interventions

The lung ultrasound score will be obtained for three groups of neonates with respiratory distress, stabilized on continuous positive airway pressure (CPAP), non-invasive ventilation and invasive venti

Eligibility

Sex/Gender

All

Age

1 Days to 1 Days

Inclusion criteria

Inclusion criteria: 1. Premature neonates with respiratory distress 3. Any gestational age 2. Enrolled within 2 hours of birth 3. Before the administration of the first surfactant dose

Exclusion criteria

Exclusion criteria: 1. Infants with major congenital malformations 2. Those who had already been given surfactant

Design outcomes

Primary

Measure	Time frame
The predictive accuracy of the lung ultrasound score of surfactant therapy measured using the Brat Score in the first 2 hours of life	—

Secondary

Measure	Time frame
1. The prognostic accuracy for surfactant administration measured using data collected from patient medical record in the whole population and the three groups of the following individual predictors at enrolment, 7 days and 36 weeks of gestational age: 1.1. SatO2/ FiO2 1.2. FiO2>0.3 1.3. OSI index 2. The prognostic accuracy for surfactant administration in the whole population of a previously developed logistic regression model based on lung ultrasound according to the Brat Score, gestational age, with/without oxygenation indexes evaluated at the enrolment. 3. The clinical trajectory and outcome of infants stabilized with techniques other than CPAP evaluating the progression of lung ultrasound score and oxygenation indexes at enrolment, 7 days and 36 weeks of gestational age and evaluating need and duration of oxygen and respiratory support, diagnosis of bronchopulmonary dysplasia and death at the end of NICU staying.	—

Measure

Time frame

1. The prognostic accuracy for surfactant administration measured using data collected from patient medical record in the whole population and the three groups of the following individual predictors at enrolment, 7 days and 36 weeks of gestational age: 1.1. SatO2/ FiO2 1.2. FiO2>0.3 1.3. OSI index 2. The prognostic accuracy for surfactant administration in the whole population of a previously developed logistic regression model based on lung ultrasound according to the Brat Score, gestational age, with/without oxygenation indexes evaluated at the enrolment. 3. The clinical trajectory and outcome of infants stabilized with techniques other than CPAP evaluating the progression of lung ultrasound score and oxygenation indexes at enrolment, 7 days and 36 weeks of gestational age and evaluating need and duration of oxygen and respiratory support, diagnosis of bronchopulmonary dysplasia and death at the end of NICU staying.

—

Countries

Italy, Spain

Contacts

Public ContactFrancesco Raimondi

raimondi@unina.it+ 39 081 746 3004

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 10, 2026