|- candidate number||14489|
|- NTR Number||NTR3891|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-mrt-2013|
|- Secondary IDs||NL35679.078.11 CCMO|
|- Public Title||Neurosis.|
|- Scientific Title||Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia.|
|- hypothesis||The hypothesis of this study is that early prophylactic inhalation of budesonide reduces the absolute risk of BPD or
death in preterm infants born <28 weeks gestational age by 10%.|
|- Healt Condition(s) or Problem(s) studied||Premature infants, Inhaled corticosteroids, Bronchopulmonary dysplasia |
|- Inclusion criteria||1. Gestational age of 23 0/7-27 6/7 weeks;|
2. Postnatal age < 12 hours;
3. Necessity for any form of positive pressure
support (mechanical or nasal ventilation or CPAP);
4. Singleton or second born in case of multiple pregnancy;
5. Parental consent for participation.
|- 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
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-mrt-2013|
|- planned closingdate||31-dec-2013|
|- Target number of participants||20|
|- Interventions||Within 2 years 850 infants of 23-27 weeks GA will be randomised during the first 12 hours of life to Budesonide (BS) or placebo
to prevent BPD. Study drugs will be administered via Aerochamber and continued until infants are either off supplementary
oxygen and poitive pressure support of have reached a GA of 32 O/7 weeks regardless of ventilatory status.|
|- Primary outcome||The primary outcome is defined as a combination of BPD or death at 36 weeks gestational age.|
|- Secondary outcome||1. Neurodevelopmental outcomes at 18 - 22 months;|
2. Adverse treatment effects;
3. Mortality at 36 weeks gestationale age;
4. BPD incidence at 36 weeks gestational age;
5. Duration of positive pressure respiratory support or supplemental oxygen.
|- Timepoints||1. 36 weeks gestational age;|
2. 22 months.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. R.K. Kornelisse|
|- CONTACT for SCIENTIFIC QUERIES||Dr. R.K. Kornelisse|
|- Sponsor/Initiator ||Neurosis study Center|
(Source(s) of Monetary or Material Support)
|Neurosis Study Center Tuebingen|
|- Brief summary||Background of the study:|
Survival of extremely low birth weight (ELBW) infants has improved in recent decades, however BPD remains a major health care problem. BPD is a chronic lung disease that occurs in premature infants. BPD not only contributes to the mortality of preterm infants but is also associated with impaired psychomotor outcome in ELBW survivors. A number of approaches followed in preventing or treating BPD have been evaluated in the context of controlled studies. Among the interventions studied are antenatal and postnatal corticosteroids Systemic postnatal corticosteroid treatment is perhaps the most controversial approach known in BPD care. Several reports on the adverse effects of dexamethasone on growth and neurodevelopmental outcomes appeared, thus the widespread use of systemic postnatal steroids was replaced by almost complete avoidance of this form of therapy. Nevertheless, the incidence of ELBW survivors with BPD is increasing and new modalities for prevention and treatment need to be explored. Inhaled corticosteroids have been established as the first-line of treatment in adults and children with persistent asthma, the most common chronic inflammatory disease. As in asthma, the biological rationale of corticosteroid therapy in infants with evolving or established BPD is based on its anti-inflammatory properties. Some trials concerning inhaled corticosteroids did not prevent BPD, but was associated with a lower use of systemic glucocorticoid therapy and mechanical ventilation. One study with Inhaled steroids resulted in a significantly higher success rate in extubation within the first 2 weeks of life and a more pronounced improvement in lung compliance. A study to evaluate the efficacy of inhaled corticosteroids seems to be justified. The hypothesis of this study is that early prophylactic inhalation of budesonide reduces the absolute risk of BPD or death in preterm infants born <28 weeks gestational age by 10%.
Objective of the study:
Primary objective - Survival without BPD at 36 weeks gestational age (GA) Secondary objectives - Neurodevelopment at a corrected age of 18-22 months - Adverse treatment effects - Mortality at 36 weeks gestational age - BPD incidence at 36 weeks gestational age - Duration of positive pressure respiratory support or supplemental oxygen.
Randomised placebo-controlled, multicentre clinical trial.
Preterm infants born between 23 0/7 and 27 6/7 weeks gestational age (GA).
Within 2 years 850 infants of 23-27 weeks GA will be randomised during the first 12 hours of life to Budesonide (BS) of placebo to prevent BPD. Study drugs will be administered via Aerochamber and continued until infants are either off supplementary oxygen and poitive pressure support of have reached a GA of 32 O/7 weeks regardless of ventilatory status.
Primary study parameters/outcome of the study:
The primary outcome is defined as a combination of BPD or death at 36 weeks gestational age.
Secundary study parameters/outcome of the study:
- Neurodevelopmental outcomes at 18 - 22 months; - Adverse treatment effects; - Mortality at 36 weeks gestationale age; - BPD incidence at 36 weeks gestational age; - Duration of positive pressure respiratory support or supplemental oxygen.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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.
|- Main changes (audit trail)|
|- RECORD||11-mrt-2013 - 26-apr-2013|