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. 2023 Mar 13;2023(3):CD010941. doi: 10.1002/14651858.CD010941.pub3

Odd 2004.

Study characteristics
Methods Single center randomized controlled trial investigating a continuous dosage regimen versus an individualized course tailored to the infants' respiratory status.
Participants Infants ≤ 1250 grams, ventilated between postnatal age of 7 days and 28 days for which dexamethasone was indicated.
Infants with congenital anomalies and surgical problems were excluded.
Interventions The included infants were randomly assigned to 1 of 2 regimens.
  1. Continuous dosage regimen: 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 per day over a further 30 days, followed by 0.1 mg/kg/day on alternate days for 1 week. Total duration was 42 days.

  2. Individual course: 0.5 mg/kg/day for 3 days, 0.3 mg/kg/day for 3 days, 0.1 mg/kg/day for 3 days, followed by 0.1 mg/kg every 72 hours until the infant was extubated and required an FiO₂ ≤ 0.25 for 3 doses. In case of clinical deterioration (increase in FiO₂ ≥ 0.15 or MAP ≥ 2 cmH₂O) the dose reverted to 0.3 mg/kg/day for 3 days, after which the same schedule was followed.

Outcomes The primary outcome was linear growth, measured by knemometry, weight, crown‐heel length, and head circumference.
Secondary outcomes were hypertension, myocardial hypertrophy, respiratory status (mode, peak inspiratory pressure, and end expiratory pressure and FiO₂ at enrolment, study days 14, 42, 28 days' postnatal age and 36 weeks' corrected gestational age, hyperglycemia requiring insulin therapy, renal and cranial ultrasounds, proven and suspected infections. In addition a Synacthen test was performed 1 week after discontinuation of the dexamethasone.
The long‐term neurodevelopmental outcome were assessed at 9 and 18 months using the Bayley Scales of Infant Development II. Infants were classified into 1 of 4 outcome categories defined and modified from Kitchen 1987.
Notes Funding: no statement.
Declarations of interest: not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk By computer generated random numbers.
Allocation concealment (selection bias) Low risk Stratified by sex and birth weight.
Blinding of participants and personnel (performance bias)
All outcomes High risk Parents and personnel were aware of the allocation of the patient.
Blinding of outcome assessment (detection bias)
All outcomes High risk Clinical outcome assessment was not blinded, although the primary outcome was (knemometry), as well as ultrasounds performed by staff unaware of treatment allocation. The developmental psychologist was also unaware of the treatment allocation.
Incomplete outcome data (attrition bias)
All outcomes Low risk In 1 infant in the individual group, the dexamethasone treatment was stopped on day 10. Intention‐to‐treat analyses were performed.
Selective reporting (reporting bias) Low risk All predefined outcomes were mentioned in the manuscript.
Other bias Unclear risk No concerns of other biases.