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Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia (NEuroSIS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Prof. Dr. med. Dirk Bassler, Msc, University Children's Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01035190
First received: December 17, 2009
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

HYPOTHESIS:

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%.

PRIMARY OBJECTIVE:

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.

SECONDARY OBJECTIVES:

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.

RATIONALE:

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.

STUDY DESIGN:

Randomised placebo-controlled, multi-centre clinical trial.

RESEARCH PLAN:

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.

CLINICAL SIGNIFICANCE:

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.


Condition Intervention Phase
Bronchopulmonary Dysplasia
Drug: Budesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia

Resource links provided by NLM:


Further study details as provided by University Children’s Hospital Tuebingen:

Primary Outcome Measures:
  • Survival without BPD at 36 weeks GA [ Time Frame: 36 weeks GA ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurodevelopment at a corrected age of 18 - 22 months. [ Time Frame: 18 - 22 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 850
Study Start Date: April 2010
Estimated Study Completion Date: September 2015
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: inhaled Budesonide Drug: Budesonide
Inhalation, 200 µg/puff
Other Name: Budiair

  Eligibility

Ages Eligible for Study:   up to 12 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a gestational age of 23 0/7-27 6/7 weeks,
  • a postnatal age < 12 hours
  • the necessity for any form of positive pressure support (mechanical or nasal ventilation or CPAP

Exclusion Criteria:

  • involve a clinical decision not to administer therapies (infant not considered viable)
  • dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment and known or suspected congenital heart disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01035190

  Show 40 Study Locations
Sponsors and Collaborators
University Children’s Hospital Tuebingen
European Union
Investigators
Principal Investigator: Prof. Dr. med. Dirk Bassler, MSc University Children's Hospital Tuebingen / University Hospital Zurich, Department of Neonatology
Principal Investigator: Prof. Dr. med. Christian F Poets Children`s Hospital, Tuebingen
  More Information

Publications:
Responsible Party: Prof. Dr. med. Dirk Bassler, Msc, Prof.Dr. med., University Children's Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01035190     History of Changes
Other Study ID Numbers: GAH-F5_2009-223060
Study First Received: December 17, 2009
Last Updated: July 23, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University Children’s Hospital Tuebingen:
Preterm Infants
Inhaled Corticosteroids
Bronchopulmonary Dysplasia

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Budesonide
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014