Neonatal European Study of Inhaled Steroids
| ISRCTN | ISRCTN80181452 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80181452 |
| ClinicalTrials.gov number | NCT01035190 |
| Secondary identifying numbers | Grand_Award_Health-F5_2009-223060 |
- Submission date
- 21/06/2010
- Registration date
- 26/07/2010
- Last edited
- 28/08/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Dirk Bassler
Scientific
Scientific
Calwerstrasse 7
Tuebingen
72076
Germany
| Phone | +49 (0)7071 2986176 |
|---|---|
| dirk.bassler@med.uni-tuebingen.de |
Study information
| Study design | European multicentre randomised placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact neurosis.studycoordinator@med.uni-tuebingen.de to request a patient information sheet |
| Scientific title | Efficacy and safety of inhaled budesonide in very preterm infants at risk for bronchopulmonary dysplasia: a phase III trial |
| Study acronym | NEuroSIS |
| Study objectives | 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(s) | The Independant Ethics Committee (IEC) of the University of Tuebingen approved on the 19th of November 2009 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Budesonide |
| Primary outcome measure | 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 study start date | 01/04/2010 |
| Completion date | 31/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 850 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/04/2010 |
| Date of final enrolment | 31/03/2012 |
Locations
Countries of recruitment
- Czech Republic
- Finland
- France
- Germany
- Israel
- Netherlands
- United Kingdom
Study participating centre
Calwerstrasse 7
Tuebingen
72076
Germany
72076
Germany
Sponsor information
University Children`s Hospital of Tuebingen (Germany)
Hospital/treatment centre
Hospital/treatment centre
Calwerstrasse 7
Tuebingen
72076
Germany
| Phone | +49 (0)7071 2986176 |
|---|---|
| neurosis.studycoordinator@med.uni-tuebingen.de | |
| Website | http://www.medizin.uni-tuebingen.de/kinder/en/ |
"ROR" |
https://ror.org/03esvmb28 |
Funders
Funder type
Government
European Union (EU) (Belgium) - Seventh Framework Programme (FP7) for Research and Technological Development (RTD) (ref: 223060)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/07/2010 | Yes | No | |
| Results article | results | 15/10/2015 | Yes | No | |
| Results article | results | 11/01/2018 | Yes | No |
Editorial Notes
28/08/2018: Publication reference added.
