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ISRCTN
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ISRCTN80181452
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ClinicalTrials.gov identifier
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NCT01035190
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Public title
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Neonatal European Study of Inhaled Steroids
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Scientific title
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Efficacy and safety of inhaled budesonide in very preterm infants at risk for bronchopulmonary dysplasia: a phase III trial
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Acronym
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NEuroSIS
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Serial number at source
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Grand_Award_Health-F5_2009-223060
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Study hypothesis
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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%.
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Lay summary
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Ethics approval
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The Independant Ethics Committee (IEC) of the University of Tuebingen approved on the 19th of November 2009
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Study design
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European multicentre randomised placebo controlled parallel group trial
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Countries of recruitment
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Czech Republic, Finland, France, Germany, Israel, Netherlands, United Kingdom
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Disease/condition/study domain
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Bronchopulmonary dysplasia
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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)
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Anticipated start date
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01/04/2010
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Anticipated end date
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31/03/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please contact neurosis.studycoordinator@med.uni-tuebingen.de to request a patient information sheet
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Target number of participants
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850
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Interventions
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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.
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Primary outcome measure(s)
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Combination of BPD or death at 36 weeks gestational age
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Secondary outcome measure(s)
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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
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Sources of funding
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European Union (EU) (Belgium) - Seventh Framework Programme (FP7) for Research and Technological Development (RTD) (ref: 223060)
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Trial website
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Publications
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2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19590247
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Contact name
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Dr
Dirk
Bassler
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Address
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Calwerstrasse 7
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City/town
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Tuebingen
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Zip/Postcode
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72076
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Country
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Germany
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Tel
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+49 (0)7071 2986176
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Fax
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+49 (0)7071 294471
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Email
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dirk.bassler@med.uni-tuebingen.de
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Sponsor
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University Children`s Hospital of Tuebingen (Germany)
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Address
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Calwerstrasse 7
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City/town
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Tuebingen
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Zip/Postcode
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72076
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Country
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Germany
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Tel
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+49 (0)7071 2986176
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Fax
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+49 (0)7071 294471
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Email
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neurosis.studycoordinator@med.uni-tuebingen.de
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Sponsor website:
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http://www.medizin.uni-tuebingen.de/kinder/en/
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Date applied
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21/06/2010
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Last edited
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26/07/2010
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Date ISRCTN assigned
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26/07/2010
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