Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia (NEuroSIS)
Recruitment status was Recruiting
|First Received Date ICMJE||December 17, 2009|
|Last Updated Date||June 28, 2010|
|Start Date ICMJE||April 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Survival without BPD at 36 weeks GA [ Time Frame: 36 weeks GA ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01035190 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Neurodevelopment at a corrected age of 18 - 22 months. [ Time Frame: 18 - 22 months ] [ Designated as safety issue: Yes ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia|
|Official Title ICMJE||Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia|
Early prophylactic inhalation of Budesonide reduces the absolute risk of developing bronchopulmonary dysplasia (BPD) or death in preterm infants born <28 weeks gestational age (GA) by 10%.
To determine whether inhalation of Budesonide within 12 hours of life improves survival without BPD at 36 weeks GA in infants born between 23 and 27 weeks GA.
To determine whether prophylactic inhalation of Budesonide affects neurodevelopment at a corrected age of 18-22 months in preterm infants; to determine whether inhalation of corticosteroids is associated with adverse treatment effects, alters mortality at 36 weeks GA, BPD incidence at 36 weeks GA, and the duration of positive pressure respiratory support or supplemental oxygen.
Pre- and postnatal exposure of the developing lung to inflammation is central to the development of BPD and the pulmonary inflammatory response in preterms at risk of developing BPD is established very early in life. Corticosteroids have antiinflammatory properties and early inhalation of corticosteroids may allow for beneficial local effects on the pulmonary system prior to the development of a full inflammatory response with a lower risk of undesirable systemic side effects.
Randomised placebo-controlled, multi-centre clinical trial.
Within 2 years 850 infants of 23-27 weeks GA will be randomised during the first 12 hours of life to Budesonide or placebo to prevent BPD. Study drugs will be administered via Aerochamber and continued until infants are either off supplementary oxygen and positive pressure support or have reached a GA of 32 0/7 weeks regardless of ventilatory status. The primary outcome of survival without BPD will be determined at 36 weeks GA and BPD will be defined according to the physiological definition. Study patients will be followed and neurodevelopmental outcomes will be assessed at a corrected age of 18-22 months.
BPD not only contributes to the mortality of preterm infants but is also associated with impaired neurosensory development in Extremely Low Birth Weight (ELBW) survivors, frequent readmission to hospital in the first 2 years of life, as well as with an increased risk of asthma, lung function abnormalities and persistent respiratory symptoms in adolescence and young adulthood. Systemic corticosteroids are effective in preventing BPD, but their use is practically prohibited given their adverse effects on neurodevelopment. Early inhalation of corticosteroids has been shown to be associated with secondary pulmonary benefits, but its effect on survival without BPD and on neurodevelopment remains unclear.
|Detailed Description||Not Provided|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Condition ICMJE||Bronchopulmonary Dysplasia|
|Intervention ICMJE||Drug: Budesonide
Inhalation, 200 µg/puff
Other Name: Budiair
|Study Arm (s)||Experimental: inhaled Budesonide
Intervention: Drug: Budesonide
|Publications *||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. 2009 Jul 7;97(1):52-55 [Epub ahead of print] No abstract available.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||850|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||up to 12 Hours|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Finland, France, Germany, Israel|
|NCT Number ICMJE||NCT01035190|
|Other Study ID Numbers ICMJE||GAH-F5_2009-223060|
|Has Data Monitoring Committee||Yes|
|Responsible Party||PD Dr. med. Dirk Bassler, MSc; Prof. Dr. med. C-F.Poets, University Children's Hospital Tuebingen|
|Study Sponsor ICMJE||University Children’s Hospital Tuebingen|
|Collaborators ICMJE||European Union|
|Information Provided By||University Children’s Hospital Tuebingen|
|Verification Date||December 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP