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Design: Single-centre, randomised clinical trial.
Allocation: Block randomisation to kangaroo care (KC) alone, KC and sucrose or sucrose alone using computerised off-site system.
Blinding: All research and clinical staff except the study research nurse were blinded to if placebo (sterile water) or 24% sucrose was given. It was not possible to blind KC. The neurodevelopmental assessments were conducted blind to group assignment.
Setting: Single tertiary neonatal centre in Eastern Canada.
Patients: Infants born less than 37 weeks within 7 days of birth who were clinically stable enough to receive KC from their mothers. Exclusion criteria were infants with congenital anomalies, infants requiring surgery or those on sedation or analgesia.
Interventions and comparisons: KC 15 min before a procedure with sucrose; or KC 15 min before a procedure with placebo (sterile water); or sucrose only 2 min prior to the procedure. The procedures were three medically indicated heel lances.
Outcomes: The primary study outcome was biobehavioural pain response. This was measured using the Premature Infant Pain Profile (PIPP) scored at 30, 60, 90 …
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