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

Autor: Andrew S. J. Marshall, Manish Sadarangani, Alexandra Scrivens, Rachel Williams, Jean Yong, Ursula Bowler, Louise Linsell, Virginia Chiocchia, Jennifer L. Bell, Caz Stokes, Patricia Santhanadass, Eleri Adams, Edmund Juszczak, Charles C. Roehr, on behalf of the ‘The NeoCLEAR Collaborative Group’
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: BMC Pediatrics, Vol 20, Iss 1, Pp 1-10 (2020)
Druh dokumentu: article
ISSN: 1471-2431
DOI: 10.1186/s12887-020-02050-8
Popis: 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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