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. |
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Interventions | The included infants were randomly assigned to 1 of 2 regimens.
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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. |
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Notes | Funding: no statement. Declarations of interest: not reported. |
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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. |