Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia (NEuroSIS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University Children’s Hospital Tuebingen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
European Union
Information provided by:
University Children’s Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01035190
First received: December 17, 2009
Last updated: June 28, 2010
Last verified: December 2009
  Purpose

HYPOTHESIS:

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.


Condition Intervention Phase
Bronchopulmonary Dysplasia
Drug: Budesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia

Resource links provided by NLM:


Further study details as provided by University Children’s Hospital Tuebingen:

Primary Outcome Measures:
  • Survival without BPD at 36 weeks GA [ Time Frame: 36 weeks GA ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurodevelopment at a corrected age of 18 - 22 months. [ Time Frame: 18 - 22 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 850
Study Start Date: April 2010
Arms Assigned Interventions
Experimental: inhaled Budesonide Drug: Budesonide
Inhalation, 200 µg/puff
Other Name: Budiair

  Eligibility

Ages Eligible for Study:   up to 12 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a gestational age of 23 0/7-27 6/7 weeks,
  • a postnatal age < 12 hours
  • the necessity for any form of positive pressure support (mechanical or nasal ventilation or CPAP

Exclusion Criteria:

  • involve a clinical decision not to administer therapies (infant not considered viable)
  • dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment and known or suspected congenital heart disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035190

Contacts
Contact: PD Dr. med. Dirk Bassler, MSc + 49 (0)7071 2980898 dirk.bassler@med.uni-tuebingen.de
Contact: Prof. Dr. med. Christian F Poets + 49 (0)7071 2984742 christian-f.poets@med.uni-tuebingen.de

Locations
Finland
Oulu University Hospital Recruiting
Oulu, Finland, 90220
Contact: Prof. Dr. med. Mikko Hallman       mikko.hallman@oulu.fi   
Principal Investigator: Prof. Dr. med. Mikko Hallman         
France
Hospital Cochin Saint-Vincent de Paul, Dept. of Neonatology Recruiting
Paris, France, 75014
Contact: Prof. Dr. med. Pierre H Jarreau       pierre-henri.jarreau@cch.aphp.fr   
Principal Investigator: Prof. Dr. med. Pierre H Jarreau         
Germany
University Children's Hospital Carl Gustav Carus Dresden, Dept. of Neonatology Recruiting
Dresden, Germany, 01307
Contact: Dr. med. Barbara Seipolt       Barbara.Seipolt@uniklinikum-dresden.de   
Principal Investigator: Dr. med. Barbara Seipolt         
University Children`s Hospital Erlangen, Dept. of Neonatology Recruiting
Erlangen, Germany, 91054
Contact: Prof. Dr. med. Wolfgang Rascher       wolfgang.rascher@uk-erlangen.de   
Principal Investigator: Prof. Dr. med. Wolfgang Rascher         
University Children`s Hospital Essen, Dept. of Pediatrics Recruiting
Essen, Germany, 45147
Contact: Dr. med. Anja Stein       anja.stein@uk-essen.de   
Principal Investigator: Dr. med. Anja Stein         
Georg-August University Hospital Goettingen, Dept. of Pediatrics Recruiting
Goettingen, Germany, 37075
Contact: Dr. med. Stephan Seeliger       seeliger@med.uni-goettingen.de   
Principal Investigator: Dr. med. Stephan Seeliger         
University Hospital Hamburg-Eppendorf, Dept. of Neonatology Recruiting
Hamburg, Germany, 20246
Contact: Dr. med. Sarah Kabisch       s.kabisch@uke.uni-hamburg.de   
Principal Investigator: Dr. med. Sarah Kabisch         
Children`s Hospital Hannover auf der Bult, Dept. of Neonatology Recruiting
Hannover, Germany, 30173
Contact: Dr. med. Anna Koluch       koluch@hka.de   
Principal Investigator: Dr. med. Anna Koluch         
University Hospital Hannover, Dept. of Neonatology Recruiting
Hannover, Germany, 30625
Contact: Dr. med. Florian Urlichs       urlichs.florian@mh-hannover.de   
Principal Investigator: Dr. med. Florian Urlichs         
University Children`s Hospital Heidelberg, Dept. of Neonatology Recruiting
Heidelberg, Germany, 69120
Contact: Prof. Dr. med. Johannes Poeschl       johannes.poeschl@med.uni-heidelberg.de   
Principal Investigator: Prof. Dr. med. Johannes Poeschl         
Children`s Hospital Mannheim Recruiting
Mannheim, Germany, 68163
Contact: Dr. med. Frederik Loersch       frederik.loersch@umm.de   
Principal Investigator: Dr. med. Frederik Loersch         
Hospital Nuernberg Sued, Dept. of Neonatology Recruiting
Nuernberg, Germany, 90471
Contact: Prof. Dr. med. Jan H Schiffmann       jan-holger.schiffmann@klinikum-nuernberg.de   
Principal Investigator: Prof. Dr. med. Jan H Schiffmann         
University Children´s Hospital Tuebingen, Dept. of Neonatology Recruiting
Tuebingen, Germany, 72076
Contact: PD Dr. med. Dirk Bassler, MSc       dirk.bassler@med.uni-tuebingen.de   
Principal Investigator: PD Dr. med. Dirk Bassler, MSc         
University Children`s Hospital Wuerzburg, Dept. of Neonatology Recruiting
Wuerzburg, Germany, 97080
Contact: Dr. med. Wolfgang Thomas       Thomas_W@kinderklinik.uni-wuerzburg.de   
Principal Investigator: Dr. med. Wolfgang Thomas         
Israel
Kaplan Medical Center Rehovot, Dept. of Neonatology Recruiting
Rehovot, Israel, 76100
Contact: Prof. Dr. med. Eric S Shinwell       Eric_S@clalit.org.il   
Principal Investigator: Prof. Dr. med. Eric S Shinwell         
Sponsors and Collaborators
University Children’s Hospital Tuebingen
European Union
Investigators
Principal Investigator: PD Dr. med. Dirk Bassler, MSc Children's Hospital Tuebingen
Principal Investigator: Prof. Dr. med. Christian F Poets Children`s Hospital, Tuebingen
  More Information

Publications:
Responsible Party: PD Dr. med. Dirk Bassler, MSc; Prof. Dr. med. C-F.Poets, University Children's Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01035190     History of Changes
Other Study ID Numbers: GAH-F5_2009-223060
Study First Received: December 17, 2009
Last Updated: June 28, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University Children’s Hospital Tuebingen:
Preterm Infants
Inhaled Corticosteroids
Bronchopulmonary Dysplasia

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014