UBC Faculty Research and Publications

Study protocol: NeoCLEAR: Neonatal Champagne Lumbar punctures Every time – An RCT: a multicentre, randomised controlled 2 × 2 factorial trial to investigate techniques to increase lumbar puncture success Marshall, Andrew S J; Sadarangani, Manish; Scrivens, Alexandra; Williams, Rachel; Yong, Jean; Bowler, Ursula; Linsell, Louise; Chiocchia, Virginia; Bell, Jennifer L; Stokes, Caz; Santhanadass, Patricia; Adams, Eleri; Juszczak, Edmund; Roehr, Charles C

Abstract

Background: The neonatal period carries the highest risk of bacterial meningitis (~ 1 in 5000 births), bearing high mortality (~ 10%) and morbidity (20–50%) rates. Lumbar puncture (LP) remains essential to the diagnosis of meningitis. Though LP is a common procedure in neonates, success rates are lower (50–60%) than in other patient populations. None of the currently-practised neonatal LP techniques are supported by evidence from adequately-powered, randomised controlled trials (RCTs). NeoCLEAR aims to compare two modifications to the traditional technique which are free, accessible, and commonly practised: sitting (as opposed to lying) position, and ‘early’ (as opposed to ‘late’) stylet removal. Methods/design Written parental informed consent permitting, infants in neonatal/maternity wards, of 27⁺ ⁰ to 44⁺ ⁰ weeks corrected gestational age and weighing ≥1000 g, who require an LP, will be randomly allocated to sitting or lying position, and to early or late stylet removal. The co-primary objectives are to compare success rates (the proportion of infants with cerebrospinal fluid red cell count

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Attribution 4.0 International (CC BY 4.0)

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