EUCTR2009-012203-26-BE
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 1, 2012
ConditionsSurvival 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Survival 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 support
- 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: 100
- •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 exclude an infant for the mentioned reasons will be left to the discretion of the attending physician.
Outcomes
Primary Outcomes
Not specified
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