Condition category
Neonatal Diseases
Date applied
21/06/2010
Date assigned
26/07/2010
Last edited
26/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.medizin.uni-tuebingen.de/kinder/en/

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

  1. 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.

Additional files

Editorial Notes