Stec 1993.
Methods | Double‐blinded randomised controlled trial. Single‐centre: St. Peter's Medical Center Intensive Care Nursery, New Brunswick, New Jersey, USA, between 1 June 1 1987 and 30 August 30 1989. |
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Participants | 42 inborn newborns (19 in the heparin group, 23 in the control group) with birth weight < 2000 grams, requirement for umbilical artery catheterisation and informed consent obtained from the parents. Gestational age and birth weight were similar in the two groups, i.e. 28 weeks ± 3 and 1096 ± 350 grams in the heparin group and 28 weeks ± 3 and 1000 ± 415 grams in the control group. |
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Interventions | Intervention group: flush solution (5% dextrose/0.2 normal saline) with 1 unit of heparin per mL. Control group: same flush solution without heparin. |
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Outcomes | Primary outcome: GM‐IVH. Secondary outcomes: severe IVH; complications of the umbilical artery catheters (hypertension, color changes of the extremities, and clotting of the catheter); need for respiratory support; pneumothorax; acidosis; sepsis; need for volume expanders; platelet count; death. |
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Notes | Lack of power of the study. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Infants were randomised by a random number table. |
Allocation concealment (selection bias) | Unclear risk | No information provided. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | The flush solutions were prepared by the hospital pharmacy and the vials' contents were unknown to the clinical staff caring for the infants. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The ultrasound studies were reviewed by a paediatric radiologist or a neuroradiologist who were unaware of the infants' clinical course. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported for all randomised infants (no drop‐outs). |
Selective reporting (reporting bias) | Unclear risk | The trial was not registered and no protocol was available. We could not ascertain if there were deviations from the original protocol in the final publication. |
Other bias | Low risk | Appears free of other bias. |