Contact information
Type
Scientific
Primary contact
Dr Dirk Bassler
ORCID ID
Contact details
Calwerstrasse 7
Tuebingen
72076
Germany
+49 (0)7071 2986176
dirk.bassler@med.uni-tuebingen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01035190
Protocol/serial number
Grand_Award_Health-F5_2009-223060
Study information
Scientific title
Efficacy and safety of inhaled budesonide in very preterm infants at risk for bronchopulmonary dysplasia: a phase III trial
Acronym
NEuroSIS
Study hypothesis
Early prophylactic inhalation of budesonide reduces the absolute risk of bronchopulmonary dysplasia (BPD) or death in preterm infants born less than 28 weeks gestational age by 10%.
Ethics approval
The Independant Ethics Committee (IEC) of the University of Tuebingen approved on the 19th of November 2009
Study design
European multicentre randomised placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact neurosis.studycoordinator@med.uni-tuebingen.de to request a patient information sheet
Condition
Bronchopulmonary dysplasia
Intervention
Active substance (inhaled Budesonide - 200 µg per puff) and placebo will be given from:
Day 1 till Day 14 2 x 2 puffs per day and from Day 15 onward 2 x 1 puff per day.
Inhalation is performed till the patients:
1. Are off supplemental oxygen and off mechanical ventilation (or CPAP) for at least 72 hours, or
2. Have reached 32 + 0 weeks of gestational age irrespective ventilatory/oxygen status
Follow up will be performed at 18 - 22 months of corrected age.
Intervention type
Drug
Phase
Phase III
Drug names
Budesonide
Primary outcome measures
Combination of BPD or death at 36 weeks gestational age
Secondary outcome measures
1. All cause mortality at 36 weeks gestational age
2. BPD at 36 weeks gestational age
3. Duration of positive pressure respiratory support and supplemental oxygen
4. Neurodevelopmental disability at 18 - 22 months corrected age
5. Adverse treatment effects
6. All grades of intraventricular haemorrhage (IVH) and/or peri-ventricular leukomalacia (PVL)
7. Patent ductus arteriosus (PDA)
8. Intestinal perforations and/or necrotising enterocolitis (NEC) (Bell stage 2 - 3)
9. Retinopathy of prematurity (ROP)
10. Culture proven infections
11. Growth
12. Length of hospitalisation
13. Infants requiring re-intubation
Overall trial start date
01/04/2010
Overall trial end date
31/03/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Gestational age of 23 0/7 - 27 6/7 weeks
2. Postnatal age less than 12 hours
3. Necessity for any form of positive pressure support (mechanical or nasal ventilation or continuous positive airway pressure [CPAP])
4. Singleton or second born in case of multiple pregnancy
5. Parental consent for participation
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
850
Participant exclusion criteria
1. Clinical decision not to administer therapies (infant not considered viable)
2. Dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment
3. Known or suspected congenital heart disease (not including a persistent ductus arteriosus and/or an atrial septum defect)
Recruitment start date
01/04/2010
Recruitment end date
31/03/2012
Locations
Countries of recruitment
Czech Republic, Finland, France, Germany, Israel, Netherlands, United Kingdom
Trial participating centre
Calwerstrasse 7
Tuebingen
72076
Germany
Sponsor information
Organisation
University Children`s Hospital of Tuebingen (Germany)
Sponsor details
Calwerstrasse 7
Tuebingen
72076
Germany
+49 (0)7071 2986176
neurosis.studycoordinator@med.uni-tuebingen.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
European Union (EU) (Belgium) - Seventh Framework Programme (FP7) for Research and Technological Development (RTD) (ref: 223060)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19590247
Publication citations
-
Protocol
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, 52-55, doi: 10.1159/000227294.