eoCLEAR: Neonatal Champagne Lumbar punctures Every time – An RCT. A multicentre, randomised controlled 2x2 factorial trial to investigate techniques to increase lumbar puncture success

niversity of Oxford0 个研究点目标入组 1,082 人开始时间: 2018年6月26日最近更新: 2024年1月8日

适应症

试验速览

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32295554/ protocol (added 24/04/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36460015/ (added 05/12/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38149666/ (added 28/12/2023)

•1. Neonates and infants in neonatal units and their maternity wards who are having a lumbar puncture
•2. Parent(s) willing and able to give informed consent
•3. Infants of corrected gestational age from 27+0 weeks to 44+0 weeks, AND working weight of 1,000 g or more
•4. First lumbar puncture for current indication

•Current exclusion criteria as of 24/04/2020:
•1. Unable to be held in sitting position (including infants intubated and mechanically-ventilated) or other clinical condition which is likely, in the opinion of the treating clinician, to make sitting difficult, or which is likely to be compromised by sitting (e.g.open gastroschisis)
•2. Previously randomised to the trial
•Previous exclusion criteria:
•1. Unable to be held in sitting position (e.g. intubated and mechanically-ventilated) or other clinical condition which is likely to make sitting difficult, or which is likely to be compromised by sitting (e.g. open gastroschisis)
•2. Previously randomised to the trial

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