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

September 6, 2021 updated by: Hospital Clinic of Barcelona

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)

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Marta Teresa-Palacio, MD
  • Phone Number: 7503 0034 93 227 56 00
  • Email: teresa@clinic.cat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard treatment group

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).
Drug: Poractant Alfa Intratracheal Suspension [Curosurf]

Poractant alfa (Curosurf®):

First dose of treatment: 200mg/Kg. Further doses (up to a total maximum of 3 within first 48 hours of life): 100mg/Kg.

Other Names:
  • Curosurf®
Experimental: Interventional treatment group
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.
Drug: Poractant Alfa Intratracheal Suspension [Curosurf]

Poractant alfa (Curosurf®):

First dose of treatment: 200mg/Kg. Further doses (up to a total maximum of 3 within first 48 hours of life): 100mg/Kg.

Other Names:
  • Curosurf®
Drug: Budesonide 0.5 MG/ML

Poractant alfa (Curosurf®) + Budesonide nebulizer solution (Budesonida Aldo-Unión 0.5mg/mL suspensión para inhalación por nebulizador®):

First dose: 200mg/Kg of surfactant + 0.25mg/Kg of budesonide. Further doses (up to a total maximum of 3 within first 48 hours of life): 100mg/Kg of surfactant + 0.25mg/Kg of budesonide.

Other Names:
  • Budesonida Aldo-Unión 0.5mg/mL suspensión para inhalación por nebulizador®
No Intervention: Control group
Infants ≤32 weeks with no indications for surfactant administration. Their clinical management will be the usual in our neonatal unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung ultrasound score at 7 days of life.
Time Frame: 7 days of life
LUS will be performed with the patients in supine position and slightly lying on the side of the taken view. Each lung will be divided in five areas through longitudinal orientation and images will be taken using the linear probe (VF 13-5MHz).
7 days of life
IL-6 concentration in respiratory secretions at 7 days of life.
Time Frame: 7 days of life
Nasopharyngeal aspirate (NPA) will be collected by standard procedure. IL-6 concentration will be determined by Human IL-6 Quantikine ELISA (R&D Systems Inc., Minneapolis, MN, USA).
7 days of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung ultrasound score at 28 days of life.
Time Frame: 28 days of life
LUS will be performed with the patients in supine position and slightly lying on the side of the taken view. Each lung will be divided in five areas through longitudinal orientation and images will be taken using the linear probe (VF 13-5MHz).
28 days of life
IL-6 concentration in respiratory secretions at 28 days of life.
Time Frame: 28 days of life
Nasopharyngeal aspirate (NPA) will be collected by standard procedure. IL-6 concentration will be determined by Human IL-6 Quantikine ELISA (R&D Systems Inc., Minneapolis, MN, USA).
28 days of life
Number of days of oxygen
Time Frame: 7 and 28 days of age, 36 weeks of post-menstrual age.
Number of days on FiO2 >21% supplied by any respiratory support
7 and 28 days of age, 36 weeks of post-menstrual age.
Number of days of respiratory support
Time Frame: 7 and 28 days of age, 36 weeks of post-menstrual age.

Number of days on each level of respiratory support:

  • No respiratory support
  • Nasal cannula at flow rates ≤ 2L/min
  • Nasal cannula at flow rates > 2L/min
  • CPAP/BIPAP
  • Invasive mechanical ventilation
7 and 28 days of age, 36 weeks of post-menstrual age.
Mean airway pressure (MAP)
Time Frame: 7 and 28 days of age, 36 weeks of post-menstrual age.
Maximum MAP mesured in cmH2O at 7 and 28 days of age, 36 weeks of postmenstrual age.
7 and 28 days of age, 36 weeks of post-menstrual age.
Incidence of bronchopulmonary dysplasia
Time Frame: 36 weeks of post-menstrual age.
BPD will be defined according to the 2001 workshop definition (Jobe AH, Bancalari E. Bronchopulmonary dysplasia. American Journal of Respiratory and Critical Care Medicine. American Lung Association; 2001; pp 1723-9).
36 weeks of post-menstrual age.
Respiratory status and neurodevelopment
Time Frame: 24 months of age.
Neurodevelopment will be assessed using Bayley-III test.
24 months of age.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2026

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BuS2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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