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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01035190
Other study ID # GAH-F5_2009-223060
Secondary ID
Status Completed
Phase Phase 3
First received December 17, 2009
Last updated July 4, 2016
Start date April 2010
Est. completion date July 2016

Study information

Verified date July 2016
Source University Children’s Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Israel: Israeli Health Ministry Pharmaceutical AdministrationItaly: The Italian Medicines AgencyNetherlands: Medicines Evaluation Board (MEB)United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 863
Est. completion date July 2016
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 12 Hours
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Budesonide
Inhalation, 200 µg/puff

Locations

Country Name City State
Belgium AZ Sint-Jan Brugge Oostende AV, Department of Neontalogy Brugge
Belgium CHU St-Pierre, UMC St-Pieter Brussels
Belgium HUDERF, Department of Neonatology Bruxelles
Belgium CHU Tivoli, Department of Neonatology La Louvière
Czech Republic University Hospital Brno, Department of Neonatology Brno
Czech Republic University Hospital Ostrava, Department of Neonatology Ostrava
Czech Republic University Hospital Plzen, Department of Neonatology Plzen
Czech Republic Charles University, General Faculty Hospital and 1st Faculty of Medicine, Department of Obstetrics and Gynecology Prague 2
Czech Republic University Hospital Motol Prague 5, Department of Neonatology Prague 5
Czech Republic University Hospital of Tomas Bati, Department of Neonatology Zlin
Finland Helsinki University Central Hospital,Hospital for Children and Adolescents, NICU Helsinki
Finland University Hospital Kuopio, NICU Kuopio
Finland Oulu University Hospital Oulu
Finland Tampere University Hospita, NICU Tampere
Finland Tartu University Children's Clinic, Paediatric Intensive Care Unit Tartu
France CHU de LilleHôpital Jeanne de Flandres, Pôle de Médecine néonataleUnité de Réanimation néonatale Lille
France Hospital Cochin Saint-Vincent de Paul, Dept. of Neonatology Paris
France Hôpital Clocheville, Service de RéanimationNéonatale Tours
Germany University Children's Hospital Aachen, Dept. of Neonatology Aachen
Germany University Children's Hospital Carl Gustav Carus Dresden, Dept. of Neonatology Dresden
Germany University Children`s Hospital Erlangen, Dept. of Neonatology Erlangen
Germany University Children`s Hospital Essen, Dept. of Pediatrics Essen
Germany Georg-August University Hospital Goettingen, Dept. of Pediatrics Goettingen
Germany University Hospital Hamburg-Eppendorf, Dept. of Neonatology Hamburg
Germany Children`s Hospital Hannover auf der Bult, Dept. of Neonatology Hannover
Germany University Hospital Hannover, Dept. of Neonatology Hannover
Germany University Children`s Hospital Heidelberg, Dept. of Neonatology Heidelberg
Germany Hospital Nuernberg Sued, Dept. of Neonatology Nuernberg
Germany University Children´s Hospital Tuebingen, Dept. of Neonatology Tuebingen
Israel Ben-Gurion University of NegevSoroka Medical Center, Neonatal Department Beer Sheva
Israel Bnai Zion Medical Center Haifa, Department of Neonatology Haifa
Israel Hadassah Medical Center, Department of Neonatology Jerusalem
Israel Meir Medical Center, Premature Baby Unit Kfar-Saba
Israel Kaplan Medical Center Rehovot, Dept. of Neonatology Rehovot
Italy Ospedale Salesi, SOD Neonatologia Ancona
Italy ASO S. Croce e Carie, Terapia Intensiva Neonatale-Neonatologia Cuneo
Italy Azienda Ospedaliera di Padova, Dipartimento di Pediatria Salus Pueri Padova
Italy Azienda Ospedaliera Universitaria Pisana, U.O. Neonatologia Pisa
Italy Ospedale Sant'Anna, Terapia Intensiva Neonatale Clinica -3°piano Torino
Netherlands Erasmus MC - Sophia, Department of Neonatology Rotterdam

Sponsors (2)

Lead Sponsor Collaborator
University Children’s Hospital Tuebingen European Union

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Finland,  France,  Germany,  Israel,  Italy,  Netherlands, 

References & Publications (1)

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. 2010;97(1):52-5. doi: 10.1159/000227294. Epub 2009 Jul 7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Survival without BPD at 36 weeks GA 36 weeks GA No
Secondary Neurodevelopment at a corrected age of 18 - 22 months. 18 - 22 months Yes
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