Outcomes of extremely preterm infants who participated in a randomised trial of dopamine for treatment of hypotension (the HIP trial) at 2 years corrected age

Objective: To determine survival and neurodevelopmental outcomes in the Hypotension in Preterm (HIP) trial. Design: Prospective follow-up of infants enrolled in randomised controlled trial. Participants: 58 infants born before 28 weeks of gestation with low mean arterial blood pressure. Intervention: Random allocation to treatment of low blood pressure values with infusion of dopamine or placebo. Primary outcome: Survival without neurodevelopmental impairment to 24 months corrected age (CA). Results: The HIP trial stopped early due to logistic and recruitment difficulties. Outcomes were determined for 55 infants (27 in the dopamine group and 28 in the placebo group) at 24 months CA. Survival without impairment was present in 13 (48%) infants in the dopamine group and 7 (25%) infants in the placebo group (OR 2.79 (95% CI 0.89, 8.72); p=0.078). The components of the primary outcome were similarly distributed between the two arms. Mean Bayley composite scores and the frequency of somatic impairments did not differ significantly between groups but infants were shorter and lighter at 2 years of age after dopamine administration. Conclusion: In this placebo-controlled trial of the treatment of hypotension in extremely preterm infants, dopamine administration did not increase survival without impairment at 2 years CA. However, the study was not sufficiently powered and a clinically important effect cannot be excluded. The role of inotropic medication in facilitating good outcomes requires further study.