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. 2017 Jan 31;2017(1):CD010941. doi: 10.1002/14651858.CD010941.pub2

McEvoy 2004.

Methods Single center randomized controlled trial
Participants Infants were included when between 7 and 21 days of postnatal age, with a birth weight of > 501 grams and < 1500 grams, a gestational age of > 24 weeks and < 32 weeks. The infants were dependent on ventilation support with 15 cycles per minute or more and oxygen levels of 30% or more at entry.
Infants with multiple congenital anomalies, systemic hypertension, congenital heart disease, IVH grade IV, renal failure, and sepsis at entry were excluded.
Interventions The included infants were randomly assigned to 1 of 2 dosage regimens.
  1. A moderate‐dosage regimen with a cumulative dose of 2.4 mg/kg of dexamethasone administered over a 7‐day course: 0.5 mg/kg/day for 3 days, then 0.25 mg/kg/day for 3 days, then 0.1 mg/kg/day for 1 day.

  2. A low‐dosage regimen with a cumulative dose of 1.0 mg/kg of dexamethasone administered over a 7‐day course: 0.2 mg/kg/day for 3 days, then 0.1 mg/kg/day for 4 days.


All medication was given divided into 2 dosages per day.
The use of open‐label dexamethasone therapy was discouraged, but could be administered at the discretion of the attending neonatologist.
Outcomes The primary outcomes were the functional residual capacity and passive respiratory compliance before and during the 7‐day therapy.
Secondary outcome measurements were the ventilator settings, the duration of mechanical ventilation, the duration of hospitalizations, CLD (defined as oxygen dependence at 36 weeks' PMA), survival without CLD, PDA, hyperglycemia, hypertension, IVH, periventricular leukomalacia, ROP, NEC, spontaneous GI perforation, sepsis, pulmonary air leaks. At 1 year of corrected age the infants were assessed for early neurodevelopmental follow‐up (cerebral palsy and Bayley Scales of Infant Development) by a developmental pediatrician, a pediatric neurologist and specialized personnel. Cerebral palsy was defined as non‐progressive motor impairment characterized by abnormal muscle tone and decreased range/control of movements. Severe cognitive delay was defined as lower than 70 on the mental developmental index (MDI) score.
Notes Additional data on duration of mechanical ventilation, failure to extubate on day 3 and 7, were retrieved from the original investigator.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Group assignment was done by the pharmacy using a randomization table.
Allocation concealment (selection bias) Low risk Investigators and clinical staff was unaware of treatment allocation, because a staff pharmacist was in charge of randomization and study drug preparation.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Although method not specified in manuscripts.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Although method not specified in manuscripts.
Incomplete outcome data (attrition bias) 
 All outcomes High risk In 3 patients of the high‐dose group, 1 dose of dexamethasone was withheld due to blood in the gastric tube or hypertension. For 1 patient of the low dose group, a dose was inadvertently not given.
66% of the survivors were assessed for follow‐up. No statement on the influence on the neurodevelopmental outcome.
Selective reporting (reporting bias) Low risk All predefined outcomes were mentioned in the manuscript.
Other bias Low risk