Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia. (BuS)

Hospital Clinic of Barcelona

Status and phase: Not yet enrolling; Phase 3

Conditions: Prematurity; Respiratory Distress Syndrome in Premature Infant; Bronchopulmonary Dysplasia

Treatments: Drug: Budesonide 0.5 MG/ML; Drug: Poractant Alfa Intratracheal Suspension [Curosurf]

Study type: Interventional

Funder types: Other

Identifiers

NCT04862377

BuS2020

Details and patient eligibility

About

This study is designed to determine whether intratracheal administration of budesonide combined with surfactant, as compared to surfactant alone, will modify ecographic (lung ultrasound score) and biological markers (IL-6 concentration in respiratory secretions) at 7 days of life in preterm infants ≤32 weeks of gestational age (GA).

Full description

Bronchopulmonary dysplasia (BPD) is one of the main morbidities associated with extreme prematurity and, despite the improvement of respiratory care in the latest years, overall incidence is not decreasing. Etiology of BPD is multifactorial and local inflammation plays an important role in it, therfore, local anti-inflammatory drugs could be effective in preventing BPD.

Recent randomised trials have shown a lower incidence of BPD/death with the use of a combination of budesonide with surfactat compared to surfactant alone, and further clinical trials are currently ongoing.

This is a controlled phase IV, randomised, unicenter clinical trial designed to evaluate the effect of intratracheal administration of budesonide combined with surfactant, as compared to surfactant alone, in BPD in preterm infants ≤32 weeks of GA. Investigators will compare ecographic and biological markers, as well as respiratory outcomes.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants born equal or earlier than 32 weeks of gestational age admitted in the Neonatal Intensive Care Unit.
• Parental consent signed.
• Less than or equal to 48 hours postnatal age.

Exclusion criteria

• Infants with known major congenital anomalies (eg. congenital upper airwayobstruction, congenital lung anomaly, severe pulmonary hypoplasia, hydrops,neuromuscular diseases, chromosomopaties)
• Infants with poor prognosis and risk of imminent death
• Infants who have received the first dose of surfactant before of the enrolment to the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 3 patient groups

Standard treatment group

Active Comparator group

Description:

Infants randomised to the "standard treatment" arm will receive intratracheal surfactant as per usual clinical indications of respiratory distress syndrome in these preterm infants. In that sense, and based in those clinical indications, we have developed a risk calculator for surfactant administration in preterm infants ≤32 weeks GA. We will use it to decide what patients will receive surfactant (calculator available on: https://1drv.ms/x/s!Arjkl83HIXSngP8TWh8O6oi6Ztdw3w?e=gNCMxP).

Treatment:

Drug: Poractant Alfa Intratracheal Suspension [Curosurf]

Interventional treatment group

Experimental group

Description:

Infants randomised to the "interventional treatment" arm will receive intratracheal surfactant mixed with budesonide. Indication of surfactant, as equal as for the "standard treatment" arm, will be decided using the calculator.

Treatment:

Drug: Poractant Alfa Intratracheal Suspension [Curosurf]

Drug: Budesonide 0.5 MG/ML

Control group

No Intervention group

Description:

Infants ≤32 weeks with no indications for surfactant administration. Their clinical management will be the usual in our neonatal unit.