Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia
NCT ID: NCT01035190
Last Updated: 2016-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
863 participants
INTERVENTIONAL
2010-04-30
2016-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Early prophylactic inhalation of Budesonide reduces the absolute risk of developing bronchopulmonary dysplasia (BPD) or death in preterm infants born \<28 weeks gestational age (GA) by 10%.
PRIMARY OBJECTIVE:
To determine whether inhalation of Budesonide within 12 hours of life improves survival without BPD at 36 weeks GA in infants born between 23 and 27 weeks GA.
SECONDARY OBJECTIVES:
To determine whether prophylactic inhalation of Budesonide affects neurodevelopment at a corrected age of 18-22 months in preterm infants; to determine whether inhalation of corticosteroids is associated with adverse treatment effects, alters mortality at 36 weeks GA, BPD incidence at 36 weeks GA, and the duration of positive pressure respiratory support or supplemental oxygen.
RATIONALE:
Pre- and postnatal exposure of the developing lung to inflammation is central to the development of BPD and the pulmonary inflammatory response in preterms at risk of developing BPD is established very early in life. Corticosteroids have antiinflammatory properties and early inhalation of corticosteroids may allow for beneficial local effects on the pulmonary system prior to the development of a full inflammatory response with a lower risk of undesirable systemic side effects.
STUDY DESIGN:
Randomised placebo-controlled, multi-centre clinical trial.
RESEARCH PLAN:
Within 2 years 850 infants of 23-27 weeks GA will be randomised during the first 12 hours of life to Budesonide or placebo to prevent BPD. Study drugs will be administered via Aerochamber and continued until infants are either off supplementary oxygen and positive pressure support or have reached a GA of 32 0/7 weeks regardless of ventilatory status. The primary outcome of survival without BPD will be determined at 36 weeks GA and BPD will be defined according to the physiological definition. Study patients will be followed and neurodevelopmental outcomes will be assessed at a corrected age of 18-22 months.
CLINICAL SIGNIFICANCE:
BPD not only contributes to the mortality of preterm infants but is also associated with impaired neurosensory development in Extremely Low Birth Weight (ELBW) survivors, frequent readmission to hospital in the first 2 years of life, as well as with an increased risk of asthma, lung function abnormalities and persistent respiratory symptoms in adolescence and young adulthood. Systemic corticosteroids are effective in preventing BPD, but their use is practically prohibited given their adverse effects on neurodevelopment. Early inhalation of corticosteroids has been shown to be associated with secondary pulmonary benefits, but its effect on survival without BPD and on neurodevelopment remains unclear.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia.
NCT03521063
Inhaled Budesonide for Non-ventilated Infants at High Risk of Bronchopulmonary Dysplasia: the i-BUD Pilot Study
NCT01895075
Intra-tracheal Instillation of Budesonide to Prevent Chronic Lung Disease
NCT05364385
Intratracheal Budesonide/Surfactant Prevents BPD
NCT03275415
Intratracheal Budesonide With Surfactant to Prevent Bronchopulmmonary Dysplasia.
NCT04862377
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
inhaled Budesonide
Budesonide
Inhalation, 200 µg/puff
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Budesonide
Inhalation, 200 µg/puff
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* a postnatal age \< 12 hours
* the necessity for any form of positive pressure support (mechanical or nasal ventilation or CPAP
Exclusion Criteria
* dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment and known or suspected congenital heart disease
12 Hours
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Union
OTHER
University Children's Hospital Tuebingen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Dr. med. Dirk Bassler, Msc
Prof.Dr. med.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Prof. Dr. med. Dirk Bassler, MSc
Role: PRINCIPAL_INVESTIGATOR
University Children's Hospital Tuebingen / University Hospital Zurich, Department of Neonatology
Prof. Dr. med. Christian F Poets
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital, Tuebingen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AZ Sint-Jan Brugge Oostende AV, Department of Neontalogy
Bruges, , Belgium
CHU St-Pierre, UMC St-Pieter
Brussels, , Belgium
HUDERF, Department of Neonatology
Brussels, , Belgium
CHU Tivoli, Department of Neonatology
La Louvière, , Belgium
University Hospital Brno, Department of Neonatology
Brno, , Czechia
University Hospital Ostrava, Department of Neonatology
Ostrava, , Czechia
University Hospital Plzen, Department of Neonatology
Pilsen, , Czechia
Charles University, General Faculty Hospital and 1st Faculty of Medicine, Department of Obstetrics and Gynecology
Prague, , Czechia
University Hospital Motol Prague 5, Department of Neonatology
Prague, , Czechia
University Hospital of Tomas Bati, Department of Neonatology
Zlín, , Czechia
Helsinki University Central Hospital,Hospital for Children and Adolescents, NICU
Helsinki, , Finland
University Hospital Kuopio, NICU
Kuopio, , Finland
Oulu University Hospital
Oulu, , Finland
Tampere University Hospita, NICU
Tampere, , Finland
Tartu University Children's Clinic, Paediatric Intensive Care Unit
Tartu, , Finland
CHU de LilleHôpital Jeanne de Flandres, Pôle de Médecine néonataleUnité de Réanimation néonatale
Lille, , France
Hospital Cochin Saint-Vincent de Paul, Dept. of Neonatology
Paris, , France
Hôpital Clocheville, Service de RéanimationNéonatale
Tours, , France
University Children's Hospital Aachen, Dept. of Neonatology
Aachen, , Germany
University Children's Hospital Carl Gustav Carus Dresden, Dept. of Neonatology
Dresden, , Germany
University Children's Hospital Erlangen, Dept. of Neonatology
Erlangen, , Germany
University Children's Hospital Essen, Dept. of Pediatrics
Essen, , Germany
Georg-August University Hospital Goettingen, Dept. of Pediatrics
Göttingen, , Germany
University Hospital Hamburg-Eppendorf, Dept. of Neonatology
Hamburg, , Germany
Children's Hospital Hannover auf der Bult, Dept. of Neonatology
Hanover, , Germany
University Hospital Hannover, Dept. of Neonatology
Hanover, , Germany
University Children's Hospital Heidelberg, Dept. of Neonatology
Heidelberg, , Germany
Hospital Nuernberg Sued, Dept. of Neonatology
Nuremberg, , Germany
University Children´s Hospital Tuebingen, Dept. of Neonatology
Tübingen, , Germany
Ben-Gurion University of NegevSoroka Medical Center, Neonatal Department
Beersheba, , Israel
Bnai Zion Medical Center Haifa, Department of Neonatology
Haifa, , Israel
Hadassah Medical Center, Department of Neonatology
Jerusalem, , Israel
Meir Medical Center, Premature Baby Unit
Kfar Saba, , Israel
Kaplan Medical Center Rehovot, Dept. of Neonatology
Rehovot, , Israel
Ospedale Salesi, SOD Neonatologia
Ancona, , Italy
ASO S. Croce e Carie, Terapia Intensiva Neonatale-Neonatologia
Cuneo, , Italy
Azienda Ospedaliera di Padova, Dipartimento di Pediatria Salus Pueri
Padua, , Italy
Azienda Ospedaliera Universitaria Pisana, U.O. Neonatologia
Pisa, , Italy
Ospedale Sant'Anna, Terapia Intensiva Neonatale Clinica -3°piano
Torino, , Italy
Erasmus MC - Sophia, Department of Neonatology
Rotterdam, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bassler D, Halliday HL, Plavka R, Hallman M, Shinwell ES, Jarreau PH, Carnielli V, van den Anker J, Schwab M, Poets CF. The Neonatal European Study of Inhaled Steroids (NEUROSIS): an eu-funded international randomised controlled trial in preterm infants. Neonatology. 2010;97(1):52-5. doi: 10.1159/000227294. Epub 2009 Jul 7. No abstract available.
Ciora OA, Seegmuller T, Fischer JS, Wirth T, Hafner F, Stoecklein S, Flemmer AW, Forster K, Kindt A, Bassler D, Poets CF, Ahmidi N, Hilgendorff A. Delineating morbidity patterns in preterm infants at near-term age using a data-driven approach. BMC Pediatr. 2024 Apr 11;24(1):249. doi: 10.1186/s12887-024-04702-5.
Bassler D, Shinwell ES, Hallman M, Jarreau PH, Plavka R, Carnielli V, Meisner C, Engel C, Koch A, Kreutzer K, van den Anker JN, Schwab M, Halliday HL, Poets CF; Neonatal European Study of Inhaled Steroids Trial Group. Long-Term Effects of Inhaled Budesonide for Bronchopulmonary Dysplasia. N Engl J Med. 2018 Jan 11;378(2):148-157. doi: 10.1056/NEJMoa1708831.
Bassler D, Plavka R, Shinwell ES, Hallman M, Jarreau PH, Carnielli V, Van den Anker JN, Meisner C, Engel C, Schwab M, Halliday HL, Poets CF; NEUROSIS Trial Group. Early Inhaled Budesonide for the Prevention of Bronchopulmonary Dysplasia. N Engl J Med. 2015 Oct 15;373(16):1497-506. doi: 10.1056/NEJMoa1501917.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GAH-F5_2009-223060
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.