Objective To examine the feasibility of a trial allocating different blood pressure (BP) intervention levels for treatment in extremely preterm infants.
Design Three-arm open randomised controlled trial performed between February 2013 and April 2015.
Setting Single tertiary level neonatal intensive care unit.
Patients Infants born <29 weeks’ gestation were eligible to participate, if parents consented and they did not have a major congenital malformation.
Interventions Infants were randomised to different levels of mean arterial BP at which they received cardiovascular support: active (<30 mm Hg), moderate (<gestational age mm Hg) or permissive (signs of poor perfusion or <19 mm Hg). Once this threshold was breached, all were managed using the same treatment guideline. BP profiles were downloaded continuously; cardiac output and carotid blood flow were measured at 1 day and 3 days, and amplitude integrated EEG was recorded during the first week. Cranial ultrasound scans were reviewed blind to study allocation.
Main outcome measure Inotrope usage and achieved BP.
Results Of 134 cases screened, 60 were enrolled, with mean gestation 25.8 weeks (SD 1.5) and birth weight 817 g (SD 190). Invasively measured BP on the first day and inotrope usage were highest in the active and lowest in the permissive arms. There were no differences in haemodynamic or EEG variables or in clinical complications. Predefined cranial ultrasound findings did not differ significantly; no infants in the active arm had parenchymal brain lesions.
Conclusion The BP threshold used to trigger treatment affects the achieved BP and inotrope usage, and it was possible to explore these effects using this study design.
Trial registration number ISRCTN83507686.
- blood pressure
- extremely preterm infant
- randomised trial
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Contributors SSP, AKS, DKS and STK devised the study concept. All authors developed the study protocol and designed the study. SSP and STK supervised and gathered data. SSP and STK analysed and interpreted the data. DFW analysed the electroencephalographic data. JKM performed statistical analysis. SSP and STK drafted the report. All authors critically revised the report. SSP and STK had full access to the data and take responsibility for the integrity of the data and accuracy of the analysis.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests DFW is an inventor on a patent US5181520 ‘Method and apparatus for analysing an electro-encephalogram’.
Patient consent Parental/guardian consent obtained.
Ethics approval National Research Ethics Service, London Surrey Borders Research Ethics Committee (12/LO/1553) .
Provenance and peer review Not commissioned; externally peer reviewed.