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

July 4, 2016 updated by: Prof. Dr. med. Dirk Bassler, Msc, University Children's Hospital Tuebingen

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

863

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • AZ Sint-Jan Brugge Oostende AV, Department of Neontalogy
      • Brussels, Belgium, 1000
        • CHU St-Pierre, UMC St-Pieter
      • Bruxelles, Belgium, 1020
        • HUDERF, Department of Neonatology
      • La Louvière, Belgium, 7100
        • CHU Tivoli, Department of Neonatology
  • Czech Republic
      • Brno, Czech Republic, 62500
        • University Hospital Brno, Department of Neonatology
      • Ostrava, Czech Republic, 70852
        • University Hospital Ostrava, Department of Neonatology
      • Plzen, Czech Republic, 30599
        • University Hospital Plzen, Department of Neonatology
      • Prague 2, Czech Republic, 12800
        • Charles University, General Faculty Hospital and 1st Faculty of Medicine, Department of Obstetrics and Gynecology
      • Prague 5, Czech Republic, 15006
        • University Hospital Motol Prague 5, Department of Neonatology
      • Zlin, Czech Republic, 76201
        • University Hospital of Tomas Bati, Department of Neonatology
  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Central Hospital,Hospital for Children and Adolescents, NICU
      • Kuopio, Finland, 70211
        • University Hospital Kuopio, NICU
      • Oulu, Finland, 90220
        • Oulu University Hospital
      • Tampere, Finland, 33521
        • Tampere University Hospita, NICU
      • Tartu, Finland, 50406
        • Tartu University Children's Clinic, Paediatric Intensive Care Unit
  • France
      • Lille, France, 59035
        • CHU de LilleHôpital Jeanne de Flandres, Pôle de Médecine néonataleUnité de Réanimation néonatale
      • Paris, France, 75014
        • Hospital Cochin Saint-Vincent de Paul, Dept. of Neonatology
      • Tours, France, 37044
        • Hôpital Clocheville, Service de RéanimationNéonatale
  • Germany
      • Aachen, Germany, 52074
        • University Children's Hospital Aachen, Dept. of Neonatology
      • Dresden, Germany, 01307
        • University Children's Hospital Carl Gustav Carus Dresden, Dept. of Neonatology
      • Erlangen, Germany, 91054
        • University Children's Hospital Erlangen, Dept. of Neonatology
      • Essen, Germany, 45147
        • University Children's Hospital Essen, Dept. of Pediatrics
      • Goettingen, Germany, 37075
        • Georg-August University Hospital Goettingen, Dept. of Pediatrics
      • Hamburg, Germany, 20246
        • University Hospital Hamburg-Eppendorf, Dept. of Neonatology
      • Hannover, Germany, 30173
        • Children's Hospital Hannover auf der Bult, Dept. of Neonatology
      • Hannover, Germany, 30625
        • University Hospital Hannover, Dept. of Neonatology
      • Heidelberg, Germany, 69120
        • University Children's Hospital Heidelberg, Dept. of Neonatology
      • Nuernberg, Germany, 90471
        • Hospital Nuernberg Sued, Dept. of Neonatology
      • Tuebingen, Germany, 72076
        • University Children´s Hospital Tuebingen, Dept. of Neonatology
  • Israel
      • Beer Sheva, Israel, 84101
        • Ben-Gurion University of NegevSoroka Medical Center, Neonatal Department
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center Haifa, Department of Neonatology
      • Jerusalem, Israel, 96757
        • Hadassah Medical Center, Department of Neonatology
      • Kfar-Saba, Israel, 44410
        • Meir Medical Center, Premature Baby Unit
      • Rehovot, Israel, 76100
        • Kaplan Medical Center Rehovot, Dept. of Neonatology
  • Italy
      • Ancona, Italy, 60123
        • Ospedale Salesi, SOD Neonatologia
      • Cuneo, Italy, 12100
        • ASO S. Croce e Carie, Terapia Intensiva Neonatale-Neonatologia
      • Padova, Italy, 35128
        • Azienda Ospedaliera di Padova, Dipartimento di Pediatria Salus Pueri
      • Pisa, Italy, 56100
        • Azienda Ospedaliera Universitaria Pisana, U.O. Neonatologia
      • Torino, Italy, 10126
        • Ospedale Sant'Anna, Terapia Intensiva Neonatale Clinica -3°piano
  • Netherlands
      • Rotterdam, Netherlands, 3015
        • Erasmus MC - Sophia, Department of Neonatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 12 hours (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: inhaled Budesonide
Drug: Budesonide
Inhalation, 200 µg/puff
Other Names:
  • Budiair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival without BPD at 36 weeks GA
Time Frame: 36 weeks GA
36 weeks GA

Secondary Outcome Measures

Outcome Measure
Time Frame
Neurodevelopment at a corrected age of 18 - 22 months.
Time Frame: 18 - 22 months
18 - 22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Children's Hospital Tuebingen

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (Estimate)

December 18, 2009

Study Record Updates

Last Update Posted (Estimate)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 4, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAH-F5_2009-223060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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