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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.

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 < 10,000/mm3 on first LP procedure) in 1020 infants between the two positions, and between the two methods of stylet removal. Secondary outcomes relate to LP procedures, complications, diagnoses of meningitis, duration of antibiotics and hospital stay. A modified intention-to-treat analysis will be conducted. DISCUSSION:Two modifications to the traditional LP technique (sitting vs lying position; and early vs late stylet removal) will be simultaneously investigated in an efficient and appropriately-powered 2 × 2 factorial RCT design. Analysis will identify the optimal techniques (in terms of obtaining easily-interpretable cerebrospinal fluid), as well as the impact on infants, parents and healthcare systems whilst providing robust safety data. Using a pragmatic RCT design, all practitioners will be trained in all LP techniques, but there will inevitably be variation between unit practice guidelines and other aspects of individual care. An improved LP technique would result in: • Fewer uninterpretable samples, repeated attempts and procedures • Reduced distress for infants and families • Decreased antibiotic use and risk of antibiotic resistance • Reduced healthcare costs due to fewer procedures, reduced length of stay, shorter antibiotic courses, and minimised antibiotic-associated complications TRIAL REGISTRATION: ISRCTN14040914. Date assigned: 26/06/2018.

SUBMITTER: Marshall ASJ

PROVIDER: S-EPMC7160994 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundLumbar puncture is often associated with uncertainty and limited experience on the part of residents; therefore, preparatory interventions can be essential. There is growing interest in the potential benefit of videos over written text. However, little attention has been given to whether the design of the videos impacts on subsequent performance.ObjectiveTo investigate the effect of different preparatory interventions on learner performance and self-confidence regarding lumbar puncture (LP).DesignRandomized controlled trial in which participants were randomly assigned to one of three interventions as preparation for performing lumbar puncture: 1) goal- and learner-centered video (GLV) presenting procedure-specific process goals and learner-centered information; 2) traditional video (TV) providing expert-driven content, but no process goals; and 3) written text (WT) with illustrations.Participants and main measuresParticipants were PGY-1 doctors without LP experience. After the preparatory intervention, participants performed an LP in a simulated setting with a standardized patient and an assistant. Two content experts, blinded to participant group allocation, assessed video recordings of the performance using the Lumbar Puncture Assessment Tool (LumPAT) and an overall global rating. Participants rated their self-confidence immediately prior to performing the procedure. The primary outcome was the difference in LumPAT scores among groups.Key resultsA total of 110 PGY-1 doctors were included. Results demonstrated significant differences in LumPAT mean scores among the three groups: GLV, 42.8; TV, 40.6; WT, 38.1 (p = 0.01). The global rating scores were highest in the GLV group (p = 0.026). Self-confidence scores differed significantly among the three groups (p = 0.003), with the TV group scoring the highest. There were no significant correlations between self-confidence scores and performance scores in any of the groups.ConclusionA video designed with procedure-specific process goals and learner-centered information resulted in better subsequent LP performance than a traditionally designed video or written text. Participants' self-confidence was not predictive of their actual performance.

Project description:Neuroinflammation is evident and one of the primary induced responses after central nervous system (CNS) injury, lumbar puncture and CNS surgery. In rare cases, complications could arise after the lumbar puncture or CNS surgery leading to inflammation, bleeding or other problems such as cerebrospinal fluid (CSF) leakage. The present dataset describes the occurrence of such a condition after the dura breakage or postoperative complication leading to the development of neuroinflammation in the adult Wistar rats. Therefore, objective of the study is to report such a rare condition and detect the most reliable glial proteins upregulated 2-3 weeks after the lumbar puncture which may help the neuroscience community to a better understanding their cause of action. In response to neuroinflammation, glial cells leak into the extracellular space, where they can be identified in the CSF or serum and may act as diagnostic biomarkers. Laminectomy was performed at the thoraco-lumbar (T12-L1) region and the dura was punctured. After that, the exposed part was covered with silica gel and adhesive followed by dental cement. The skin was closed using sterile sutures. After, the rats were given buprenorphine (0.05 mg/kg, every 8 h for 3 days) and carprofen (5 mg/kg, once a day for 5 days) as analgesic and anti-inflammatory and baytril (5 mg/kg, once a day for 10 days) as antibiotic drugs. Note, the buprenorphine and lidocaine were also given before starting the procedure. After the laminectomy, the functional outcomes of the rats were tested (starting from the day of surgery to the last day) and the rats which were locomoting normally using all the limbs were included in the study. In case of any decompression, the functional outcomes showing any kind of laming or partial paralysis of hindlimbs were excluded from the study. Unexpected neuroinflammation has occurred 2-3 weeks after performing the given procedure. Data presented in the article implicate active microglia measured by using protein biomarker such as Iba-1 [1, 3] and astrocytes measured by using Glial fibrillary acidic protein (GFAP) [2, 3] and S100 (strongly targets S100B and weakly A1) [7, 8] in the CSF collected two-three weeks after the laminectomy and dura breakage from the adult rats. Later paraformaldehyde (PFA) fixed spinal cord slices were also collected from the animals and immunolabelled with the same biomarkers. Western blots were performed with the collected CSF which showed high expression of glial markers such as GFAP, Iba-1 and S100 which has shown to target S100B with no expression of A1 (or A2, play an important role in neuroprotection) astrocytes which have recently been shown to be produced by microglia at the site of injury [9]. However, S100B [10] and GFAP [2] are known to be adequately discharged by the distinct cells in stress conditions which seems to occur in the present report. In addition, the spinal slices immunolabelled with the same biomarkers also showed increased expression of glia. Cross-talk between microglia-astrocyte in CNS stress is crucial for the neurons to survive and function after the injury. Reactive microglia (shown by high Iba-1 expression) leading to microgliosis comprise the first line of defense to phagocytose the dead cells [11]. Astrocytes act as the second line of defense leading to a process known as astrogliosis and upregulate GFAP and S100B to limit the damage [12]. Further studies are needed to explain the molecular mechanism/s of different astrocytes release such as A2 and their interaction with microglia after the lumbar puncture.

Dataset Information

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.

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