Bloomfield 1998.
Methods | Randomized controlled trial comparing a pulse course against high‐dosage regimen dexamethasone. | |
Participants | Infants with a birth weight ≤ 1250 grams, and ventilated at ≥ 15 cycles/min at 7 days of age. Infants with major congenital malformations or who were ventilated for surgical reasons were excluded. |
|
Interventions | The infants were randomly assigned to 1 of 2 regimens.
The initial dosage administration of 0.5 mg/kg/day was in 2 divided doses. |
|
Outcomes | The primary outcome was linear growth, measured as weight gain, crown‐heel length, and head circumference. Secondary outcomes were hypertension, hyperglycemia requiring insulin therapy, necrotizing enterocolitis, retinopathy of prematurity, proven infections, myocardial hypertrophy, supplemental oxygen at 28 days' PNA and 36 weeks' PMA, BPD at 28 days' PNA and 36 weeks' PMA. In addition a Synacthen test was performed 1 week after discontinuation of the dexamethasone. The long‐term follow‐up manuscript reported on neurodevelopmental outcome with an extended inclusion rate. Infants were classified into 1 of 4 outcome categories defined and modified from Kitchen 1987. |
|
Notes | Original authors provided additional data. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | By computer randomization. |
Allocation concealment (selection bias) | Low risk | By computer randomization, no additional details. Randomizaton was balanced in blocks of 6 and stratified by sex and birth weight. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis. 1 infant was found to have a birth weight of > 1250 grams. 3 infants were lost to follow‐up. |
Selective reporting (reporting bias) | Low risk | All predefined outcomes were mentioned in the manuscript. |
Other bias | Low risk | No concerns of other biases. |