NEUROSIS

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

 Partecipanti

Mappa

 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

 Obiettivo del progetto (Objective)

'HYPOTHESIS: Early inhalation of Budesonide (BS) reduces the absolute risk of developing bronchopulmonary dysplasia (BPD) or death in preterm infants born between 23 and 27 weeks gestational age (GA) by 10%. PRIMARY OBJECTIVE: Survival without BPD at 36 weeks GA. SECONDARY OBJECTIVES: (1) neurodevelopment at a corrected age of 18-22 months; (2) adverse treatment effects; (3) mortality at 36 weeks GA; (4) BPD incidence at 36 weeks GA; (5) duration of positive pressure respiratory support or supplemental oxygen; (6) pharmacokinetic-pharamacodynamic analyses. RATIONALE: Inflammation is central to the development of BPD. Corticosteroids (CS) have antiinflammatory properties and early inhalation of CS may allow for beneficial local effects on the pulmonary system with a lower risk of undesirable systemic side effects. STUDY DESIGN: Randomised placebo-controlled, multi-centre clinical trial and genetic/pharmacogenetic substudy. RESEARCH PLAN: Within 2 years 850 infants of 23-27 weeks GA will be randomised during the first 12 hours of life to BS 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. Study patients will be followed and neurodevelopmental outcomes will be assessed at a corrected age of 18-22 months. CLINICAL SIGNIFICANCE: BPD contributes to the mortality of preterm infants and is associated with impaired neurosensory development and an increased risk of pulmonary morbidity in adolescence and young adulthood. Systemic CS are effective in preventing BPD, but their use is practically prohibited given their adverse effects on neurodevelopment. Early inhalation of CS has been shown to be associated with secondary pulmonary benefits, but its effect on survival without BPD and on neurodevelopment remains unclear.'

Introduzione (Teaser)

Bronchopulmonary dysplasia (BPD) is a chronic lung disorder that is most common among children who are born prematurely. A safe therapy for BPD treatment would be extremely valuable from an individual patient as well as an economic health care perspective.

Descrizione progetto (Article)

BPD involves abnormal development of lung tissue, and is characterised by inflammation and scarring in the lungs. It develops most often in premature babies, who are born with underdeveloped lungs. BPD results in significant morbidity and mortality.

Systemic corticosteroids are effective in preventing BPD, but their use is practically prohibited given their adverse effects on neurodevelopment. Early inhalation of corticosteroids is associated with pulmonary benefits, but its effect on survival without BPD and on neurodevelopment remains unclear.

The EU funded the http://www.neurosis-study.eu (NEUROSIS) project to determine whether early inhalation of corticosteroid budesonide improves survival without BPD at 36 weeks of gestation in infants born between 23 and 27 weeks. NEUROSIS is an international multi-centre randomised controlled blinded study in a population of 850 pre-term infants.

Approvals from the national competent authorities and the research ethics boards have been obtained in all countries. The project will focus on data analysis and the follow-up of neurodevelopmental assessment.NEUROSIS is one of the largest randomised controlled studies in pre-term neonates ever conducted in Europe. Its results have the potential to make an important impact on the economics of premature baby health care.