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.

Coombe Women and Infants University Hospital Dublin Ireland

Department of Neonatology Tomas Bata University in Zlin Zlin Czech Republic

Department of Paediatrics and Child Health INFANT Centre University College Cork Cork Ireland

Department of Paediatrics Rotunda Hospital Dublin Ireland

Department of Pediatrics and Neonatal Care Ostravska Univerzita Ostrava Czech Republic

Department of Pediatrics University of Alberta Edmonton Alberta Canada

Groupe Hospitalier Cochin Broca Hôtel Dieu AP HP Clinical Pharmacology Paris France

Institute for the Care of Mother and Child 3rd Faculty of Medicine Charles University Prague Czech Republic

Institute for Womens Health University College London London UK

Neonatal Unit National Maternity Hospital Neonatal Unit Dublin Ireland

Neonatologie Centre Hospitalier Universitaire Sainte Justine Montreal Quebec Canada

Neonatology Institute for the Care of Mother and Child Prague Czech Republic

Neonatology University Hospitals Leuven Leuven Belgium

NICU UZ Antwerp Edegem Belgium

RCSI Royal College of Surgeons in Ireland Dublin Dublin Ireland

Royal College of Surgeons in Ireland Faculty of Medicine and Health Sciences Dublin Ireland

University College Dublin School of Medicine Dublin Ireland

UZ Leuven Leuven Belgium

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