Ignite Creation Date:
2024-05-05 @ 10:08 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01035190
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2009-12-17
Brief Title:
Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia
Sponsor:
University Childrens Hospital Tuebingen
Organization:
University Childrens Hospital Tuebingen
Study Overview
Official Title:
Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEuroSIS
Brief 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 07 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
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 07 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None