Blood pressure intervention levels in preterm infants: pilot randomised trial

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Abstract

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 (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.

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