Groneck 1999.

Methods	Open comparative study. Blinding of randomisation: No. (alternate allocation) Blinding of intervention: No Blinding of outcome measurement: No Complete follow up: Yes Study period: 5 month period ‐ dates not stated. Study location: Neonatal intensive care units of the Children’s Hospital in Cologne, and the Perinatal Center at Women’s Hospital, Cologne‐Holweide, Cologne, Germany.
Participants	Preterm neonates < 1200 g, mechanically ventilated and requiring FiO₂ > 0.30 on third day of life. 16 infants entered into the study. Demographic data: Values presented as mean (range) or as numbers (percentage) Inhaled steroid group N = 7 Birth weight: 800 g (range = 500 to 1020 g) Gestational age (weeks): 26.1 (range = 25 to 28 weeks) Male/female ratio: 3/4 Maternal steroids: 5 Maximum oxygenation index on day 1: 9.5 (5.6 to 19.6) Systemic steroid group N = 9 Birth weight: 847 g (range = 660 to 1030 g) Gestational age: 26.2 weeks (range = 25 to 28 weeks) Male/female ratio: 3/6 Maternal steroids: 7 Maximum oxygenation index on day 1: 10.5 (5.3 to 16.0)
Interventions	Inhaled beclomethasone (Sanasthmax, Glaxo, Bad Oldesloe, Germany) was given from day 3 to day 28. It was administered by an Aerochamber (Trudell Medical, London, Ontario, Canada) into the ventilatory circuit at a dose of 3 x 2 puffs of 250 µg. After extubation, inhalation therapy was continued by face mask, and the aero chamber was connected to a ventilation bag. 7 infants received inhaled beclomethasone while 9 received systemic dexamethasone. No systemic steroids were given to infants treated with inhaled steroids during the first month. Systemic dexamethasone was given thereafter if the infant was still on mechanical ventilation. Systemic dexamethasone was given at starting dose of 0.5 mg/kg/day for 3 days; thereafter the dose was gradually tapered over 10 or 28 days depending on the clinical status of the baby. Duration of treatment was at the discretion of attending physician.
Outcomes	Pulmonary inflammation (assessed by analysing levels of inflammatory mediators like free elastase, secretory component of IgA albumin, interleukin‐8 and elastase alpha‐1 proteinase inhibitor) in tracheal aspirates. Other outcome variables were days on mechanical ventilation, days on supplemental oxygen and BPD (oxygen dependency and radiological abnormalities on day 28).
Notes	Due to poor clinical results (BPD in 6/7 infants), allocation to inhaled steroids was stopped for ethical reasons after treatment of 7 neonates. The study received grant sponsorship from Deutsche Forschungsgemeinschaft.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	No information provided on random sequence generation
Allocation concealment (selection bias)	High risk	Open comparative study. Infants were assigned by alternate allocation
Blinding (performance bias and detection bias) All outcomes	High risk	The intervention allocation was known to staff
Blinding of participants and personnel (performance bias) All outcomes	High risk	The intervention allocation was known to personnel
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessments were performed by personnel, who knew the allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	All infants, who entered the study were accounted for
Selective reporting (reporting bias)	Unclear risk	The study protocol was not available to us so we cannot judge if there were any deviations from the protocol or not
Other bias	High risk	The study was closed prematurely