Neonatal European Study of Inhaled Steroids

ISRCTN	ISRCTN80181452
DOI	https://doi.org/10.1186/ISRCTN80181452
ClinicalTrials.gov (NCT)	NCT01035190
Protocol serial number	Grand_Award_Health-F5_2009-223060
Sponsor	University Children`s Hospital of Tuebingen (Germany)
Funder	European Union (EU) (Belgium) - Seventh Framework Programme (FP7) for Research and Technological Development (RTD) (ref: 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

Calwerstrasse 7
Tuebingen
72076
Germany

Phone	+49 (0)7071 2986176
Email	dirk.bassler@med.uni-tuebingen.de

Study information

Primary study design	Interventional
Study design	European multicentre randomised placebo controlled parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase III
Drug / device / biological / vaccine name(s)	Budesonide
Primary outcome measure(s)	Combination of BPD or death at 36 weeks gestational age
Key secondary outcome measure(s)	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
Completion date	31/03/2012

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	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

United Kingdom
Czech Republic
Finland
France
Germany
Israel
Netherlands

Study participating centre

Calwerstrasse 7

Tuebingen
72076
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/10/2015		Yes	No
Results article	results	11/01/2018		Yes	No
Protocol article	protocol	01/07/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

28/08/2018: Publication reference added.