EUCTR2009-012203-26-DE
Active, not recruiting
Phase 1
Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia - NEUROSIS
niversity Children's Hospital, Department of Neonatology0 sites850 target enrollmentJune 22, 2009
DrugsBudiair
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Children's Hospital, Department of Neonatology
- Enrollment
- 850
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A gestational age of 23 0/7\-27 6/7 weeks,a postnatal age \< 12 hours,
- •the requirement for any form of positive pressure support (mechanical or nasal ventilation or CPAP) and parental consent for participation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •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 (not including a persistent ductus arteriosus and/or an atrial septum defect). The clinical assessment of dysmorphic features, congenital malformations, suspected congenital heart disease and the decision to exlude an infant for the afore mentioned reasons will be left to the discretion of the attending physician.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia - NEUROSISHigh risk of bronchopulmonary dysplasia in very preterm neonatesMedDRA version: 12.1Level: LLTClassification code 10006475Term: Bronchopulmonary dysplasiaEUCTR2009-012203-26-EEniversitätsklinikum Tübingen863
Active, not recruiting
Phase 1
Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary DysplasiaSurvival of extremely Low Birth Weight (ELBW) infants has improved in recent decades but Bronchopulmonary Dysplasia (BPD) remains a major health care problem. BPD is a chronic lung disease that occurs in premature infants requiring mechanical ventilation and oxygen therapy, but also develops in preterm neonates who require little or no ventilatory or oxygen supportMedDRA version: 14.1Level: PTClassification code 10006475Term: Bronchopulmonary dysplasiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2009-012203-26-BEniversity Children’s Hospital, Department of Neonatology850
Active, not recruiting
Phase 1
Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia - NEUROSISEUCTR2009-012203-26-NLniversity Children's Hospital, Department of Neonatology850
Active, not recruiting
Phase 1
eonatal European Study of Inhaled SteroidsRisk of Bronchopulmonary Dysplasia at Very Preterm InfantsMedDRA version: 14.1Level: PTClassification code 10006475Term: Bronchopulmonary dysplasiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]EUCTR2009-012203-26-GRniversity Children's Hospital, Department of Neonatology863
Active, not recruiting
Phase 1
Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia - NEUROSISEUCTR2009-012203-26-CZniversity Children's Hospital, Department of Neonatology863