The Neonatal European Study of Inhaled Steroids (NEuroSIS) is a randomized, placebo-controlled international multicentre clinical trial.
The study focuses on preterm infants born at < 28 weeks of gestational age (GA) and the main objective is to determine whether the early inhalation of budesonide reduces the risk of mortality and BPD.
A total of 850 infants born between 23 0/7 and 27 6/7 weeks postmenstrual age (PMA) will be recruited. Infants will be randomized into two groups within the first 12 hours of life, with one group receiving budesonide and, the other, the placebo.
The entry criteria are as follows:
- a GA of 23 0/7 to 27 6/7 weeks
- a postnatal age ≤ 12 hours
- any form of positive pressure support (either mechanical or nasal ventilation or CPAP)
- singleton or second-born (in a multiple pregnancy) and
- parental informed consent
Exclusion criteria involve:
- a clinical decision to only administer palliative care
- dysmorphic features or congenital malformations and
- known or suspected congenital heart disease (except PDA, ASD)
The study drugs will be administered via a spacer device, until the infants do not need either supplemental oxygen or positive pressure support or have reached a postmenstrual age of 32 0/7 weeks PMA, regardless of ventilatory status.
The primary outcome of survival without BPD will be determined at 36 weeks PMA. BPD will be defined according to the physiological definition.
The neurodevelopmental outcomes of the studied patients will be assessed at a corrected age of 18-22 months.
The results of NEuroSIS will provide useful indications about the efficacy and safety of inhaled steroids in very preterm infants.
NEuroSIS is funded by the European Union (Grant Award Health F5-2009-223060), according to its 7th framework program.