Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2009-012203-26-FR
EUCTR2009-012203-26-FR
Active, not recruiting
Phase 1

Efficacy and safety of inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia.

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 sites850 target enrollmentFebruary 15, 2010
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsThis trial will be conducted in a population of preterm infants who are at high risk of developing BPD. It will not only enroll infants requiring mechanical ventilation, but also infants on nasal ventilation or continuous positive airway pressure (CPAP). The latter group does not appear to be significantly affected by lung disease shortly after birthhowever, it is at high risk of developing the new BPD.MedDRA version: 8.1 Level: PT Classification code 10006475 Term: Bronchopulmonary Dysplasia
DrugsBudiair

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
This trial will be conducted in a population of preterm infants who are at high risk of developing BPD. It will not only enroll infants requiring mechanical ventilation, but also infants on nasal ventilation or continuous positive airway pressure (CPAP). The latter group does not appear to be significantly affected by lung disease shortly after birth
Sponsor
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Enrollment
850
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 15, 2010
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •A gestational age of 23 0/7\- 27 6/7 weeks, a postnatal age a postnatal age \< 12 hours, the necessity for any form of positive pressure support (mechanical or nasal ventilation or CPAP), singleton or second born in case of multiple pregnancy 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 including all congenital pulmonary malformations, 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 aforementioned reasons will be left to the discretion of the attending physician.
  • •Other exclusion criteria are: nosocomial pulmonary viral infections and hypersensitivity to any component of inhaled budesonide (budesonide itself, glycerol, ethanol, HFA\-134A (norflurane)).

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 dysplasia
EUCTR2009-012203-26-EEniversitätsklinikum Tübingen863
Active, not recruiting
Phase 1
Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia - NEUROSIS
EUCTR2009-012203-26-DEniversity 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 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 - NEUROSIS
EUCTR2009-012203-26-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