Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.

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Brief Title

Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.

Official Title

Efficacy and Safety of the Intratracheal Administration of Budesonide With Porcine Pulmonary Surfactant in Very Preterm Infants to Prevent Bronchopulmonary Dysplasia: Randomized Clinical Trial (BuS Trial)

Brief Summary

      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).
    

Detailed 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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Lung ultrasound score at 7 days of life.

Secondary Outcome

 Lung ultrasound score at 28 days of life.

Condition

Bronchopulmonary Dysplasia

Intervention

Poractant Alfa Intratracheal Suspension [Curosurf]

Study Arms / Comparison Groups

 Standard treatment 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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

50

Start Date

October 1, 2021

Completion Date

April 1, 2026

Primary Completion Date

April 1, 2024

Eligibility Criteria

        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.
      

Gender

All

Ages

N/A - 48 Hours

Accepts Healthy Volunteers

No

Contacts

Marta Teresa-Palacio, MD, 0034 93 227 56 00, [email protected]



Administrative Informations


NCT ID

NCT04862377

Organization ID

BuS2020


Responsible Party

Sponsor

Study Sponsor

Hospital Clinic of Barcelona


Study Sponsor

Marta Teresa-Palacio, MD, Principal Investigator, Hospital Clinic of Barcelona


Verification Date

April 2021