Table 3.

Randomized controlled trials comparing different doses of dexamethasone.

Reference (authors, year)	Population (n)	Inclusion criteria	Exclusion criteria	Doses of steroids (intervention)	Doses of steroids (control)	Start at	Extubation (days of life)	Duration of therapy by protocol (days)	More than one cycle of steroids	Administration of other steroids
Marr (47)	Intervention: 30 Control: 29	GA ≤28 weeks radiographic findings consistent with the diagnosis of evolving BPD and ventilator support	Preexisting conditions with known increased risk for neurodevelopmental impairment. Infants with sepsis or significant patent ductus arteriosus became study-eligible if treated before the end of the enrollment window	42-day group: 0.5 mg/kg/day for the first 3 days and 0.3 mg/kg/day for the next 3 days. The dose was reduced by 10% every 3 days until a dose of 0.1 mg/kg was reached on day 34. Thereafter, this dose was maintained for 3 days, alternated daily with a saline placebo for 1 week, and then discontinued	9-day group: dexamethasone: 0.5 mg/kg/day for the first 3 days, 0.25 mg/kg/day for the next 3 days, and then 0.125 mg/kg/day for 3 days, followed by saline placebo	10–21 days of life	Intervention: 23 Control: 35	Intervention: 42 Control: 9	66% in the 9-day group qualified for only 1 course of dexamethasone, 17% received 2 courses, and 17% received all 3 courses	Two infants in each group received hydrocortisone for the treatment of refractory hypotension prior to study enrollment. One infant in the 42-day group developed hypertension and required a single dexamethasone dose reduction
Odd (48)	Intervention: 16 Control: 17	BW ≤1,250 g, ventilated between 1 and 3 weeks of life	Anomalies and surgical problems	0.5 mg/kg/day for 3 days, 0.3 mg/kg/day for 3 days, then a dose decreasing by 10% every 3 days to 0.1 mg/kg/day over a further 30 days, then 0.1 mg/kg on alternate days for one further week	0.5 mg/kg/day for 3 days, 0.3 mg/kg/day for 3 days, 0.1 mg/kg/day for 3 days, then 0.1 mg/kg every 72 h until the infant was extubated and required a FiO2 <0.25 for three doses (9 days)	After 7 days of life	Intervention: 17 Control: 22	42	ND	ND
Malloy (49)	Intervention: 8 Control: 8	GA <34 weeks BW ≤1,500 g ventilator dependent	Congenital and chromosomal anomalies, necrotizing enterocolitis, or culture-proven sepsis, who had already received any corticosteroid treatment	0.5 mg/kg/day for 3 days followed by 0.3 mg/kg/day for 4 days, every 12 h	0.08 mg/kg/day for 7 days, every 12 h	<28 days of age	ND	Intervention: 16 Control: 13	ND	ND
McEvoy (50)	Intervention: 29 Control: 33	BW <1,500 g, GA <32 weeks, ventilator dependent at 7–21 days	Congenital anomalies, documented sepsis, systemic hypertension, renal failure, and grade IV intraventricular hemorrhage	0.5 mg/kg/day for 3 days, 0.25 mg/kg/day for 3 days, and 0.1 mg/kg/day on day 7 (total dose of 2.35 mg/kg). All daily doses administered every 12 h	0.2 mg/kg/day for 3 days and 0.1 mg/kg/day for 4 days (total dose of 1 mg/kg). All daily doses administered every 12 h	7–14 days of age	ND	7	ND	Three infants in the high dose and one in the low dose had one dose held: 2, secondary to bright red blood in the orogastric tube; 1, due to increased systolic blood pressure; 1, inadvertently not given
Durand (51)	Intervention: 23 Control: 24	BW <1,500 g, GA <32 weeks, ventilator dependent at 7–21 days	Documented sepsis, systemic hypertension, renal failure, grade IV intraventricular hemorrhage, and congenital anomalies or chromosomal abnormalities	0.5 mg/kg/day for 3 days, 0.25 mg/kg/day for 3 days, and 0.1 mg/kg/day on day 7 (total dose of 2.35 mg/kg). All daily doses administered every 12 h	0.2 mg/kg/day for 3 days and 0.1 mg/kg/day for 4 days (total dose of 1 mg/kg). All daily doses administered every 12 h	7–14 days of age	ND	7	ND	After the study period, 5 patients (22%) in the high dose and 7 (29%) in the low dose were treated with dexamethasone at a later postnatal age, at the discretion of the neonatologist
Armstrong (52)	Intervention: 31 Control: 33	BW <1,250 g and ventilated at >15 cycles/minute at 7 days of life	Major congenital malformation or who were ventilated for surgical reasons	(Long group) 0.5 mg/kg/day for 3 days, reduced to 0.3 mg/kg/day for 3 days and thereafter reduced by 10% every 3 days to wean over 42 days	(Pulse group) 0.5 mg/kg/day for 3 days, repeated every 10 days until infants no longer required ventilatory support or supplemental oxygen or until 36 weeks of age	At 7 days of life	ND	ND	ND	Eleven babies received steroids outside the study protocol and were not randomized
Merz (53)	Intervention: 15 Control: 15	BW <1,250 g, GA <30 weeks, ventilator dependent at 7 days	Sepsis, congenital anomalies, suspected chromosomal abnormalities, or evidence of systemic hypertension	At 7 days of life (early treatment group). Starting dose of 0.5 mg/kg per day on the first 3 days followed by 0.3 mg/kg on days 4–6. From day 7 0.1 mg/kg, given alternatively every 2nd day from days 10 to 16	At 14 days of life same doses of the intervention group (late treatment group)	From day 7 or day 14 of life	Intervention: 14 Control: 24	10–16	ND	ND
Bloomfield (54)	Intervention: 21 Control: 19	BW <1,250 G and ventilated At >15 cycles/min at 7 days of life	Congenital malformation or who were ventilated for surgical reasons	(Long group) 0.5 Mg/Kg/Day for 3 days, reduced to 0.3 Mg/Kg/Day for 3 days and thereafter reduced by 10% every 3 days to wean over 42 days	(Pulse group) 0.5 Mg/Kg/Day for 3 days, repeated every 10 days until infants no longer required ventilatory support or supplemental oxygen or until 36 weeks of age	At 7 days of life	Intervention: 42 Control: 34	ND	ND	ND

ND, not declared; GA, gestational age; BW, birth weight; BPD, bronchopulmonary dysplasia.