Fajardo 1992.
Methods | Single centre randomized trial. Masking of allocation: not stated. Masking of intervention: yes, the low dose dopamine and no dopamine groups were masked. Masking of outcome assessment: not clear. Completeness of outcome assement: yes. | |
Participants | 26 preterm (<36 weeks gestation) infants with symptomatic PDA, hemodynamically significant by echocardiogram, were randomly allocated, 14 to the dopamine group and 12 to the control group. An additional group of 10 non randomized dopamine infants received a higher dosage of 5 microg/kg/min after the initial dose did not show an effect. (these non‐randomized infants were not included in this review). | |
Interventions | Dopamine was commenced at 2 microg/kg/min, (n=14), 6 hours before the first dose of indomethacin. The latter was administered every 12 hours for 3 doses ranging from 0.1 to 0.25 mg/kg depending on postnatal age. | |
Outcomes | Failure to close the ductus arteriosus, indices of renal function. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Adequate sequence generation: not stated. |
Allocation concealment? | Unclear risk | Masking of allocation: not stated. |
Blinding? All outcomes | Unclear risk | Masking of intervention: yes, the low dose dopamine and no dopamine groups were masked. Masking of outcome assessment: not clear. |
Incomplete outcome data addressed? All outcomes | Low risk | Completeness of outcome assement: yes. |