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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Survival without BPD at 36 weeks GA

Secondary Outcome

 Neurodevelopment at a corrected age of 18 - 22 months.

Condition

Bronchopulmonary Dysplasia

Intervention

Budesonide

Study Arms / Comparison Groups

 inhaled Budesonide
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

863

Start Date

April 2010

Completion Date

July 2016

Primary Completion Date

October 2013

Eligibility 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
      

Gender

All

Ages

N/A - 12 Hours

Accepts Healthy Volunteers

No

Contacts

Prof. Dr. med. Dirk Bassler, MSc, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT01035190

Organization ID

GAH-F5_2009-223060


Responsible Party

Principal Investigator

Study Sponsor

University Children's Hospital Tuebingen

Collaborators

 European Union

Study Sponsor

Prof. Dr. med. Dirk Bassler, MSc, Principal Investigator, University Children's Hospital Tuebingen / University Hospital Zurich, Department of Neonatology


Verification Date

July 2016