Lee 1995.
Methods | Single‐centre randomised control trial | |
Participants | Inborn and outborn infants with a birth weight < 1500 g | |
Interventions | One group of infants (unwashed RBC group) were randomised to receive type‐specific packed RBCs from dedicated donor (either community or directed donation) units equipped with 7 satellite bags. The other group of infants (washed RBC group) received packed RBCs from units divided into 3 split packs shared with other infants receiving transfusions | |
Outcomes | The primary outcome of the study was number of donor exposures per infant | |
Notes | Infants were monitored until 1‐hour post‐transfusion for acute transfusion reactions. Data regarding demographics, length of hospital stay, days of mechanical ventilation, days of supplemental oxygen use, and RBC transfusion details were collected | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information provided |
Allocation concealment (selection bias) | Low risk | Study infants were randomly assigned by hospital blood bank personnel into 1 of 2 groups |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Transfusions were ordered by primary caretakers who were masked to study group assignments. RBCs were processed by hospital blood bank personnel and sent to the neonatal intensive care unit in syringes unmarked as to study group assignment |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Low risk for mortality; unclear risk for other outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Two infants withdrew from the study after randomisation, but this level of missing data is unlikely to affect observed results |
Selective reporting (reporting bias) | Unclear risk | No published study protocol was available to review |
Other bias | Low risk | No other risks of bias were identified |
RBC: red blood cell