Assessment of infant position and timing of stylet removal to improve lumbar puncture success in neonates (NeoCLEAR): an open-label, 2 × 2 factorial, randomised, controlled trial (Code-T0205)

Introduction: Neonatal lumbar puncture (LP) is a crucial diagnostic procedure for bacterial meningitis. However, its success rate is often low, necessitating modifications to traditional techniques. The NeoCLEAR trial aimed to optimize neonatal LP success by evaluating the impact of sitting versus lying position and early versus late stylet removal on first-attempt success rates.

Aims and Objectives: To compare the efficacy of sitting and lying positions, as well as early versus late stylet removal, in improving the success rate of neonatal LP while assessing safety and feasibility.

Methods: A randomized, controlled, 2 × 2 factorial trial was conducted across 21 UK neonatal and maternity units. A total of 1,082 neonates (27–44 weeks gestation, ≥1000g) requiring LP were randomly assigned into four groups: sitting with early stylet removal, sitting with late stylet removal, lying with early stylet removal, and lying with late stylet removal. The primary outcome was first-attempt success, defined as cerebrospinal fluid (CSF) collection with <10,000 red blood cells/µL. Secondary outcomes included oxygen desaturation and other safety parameters.

Results: Sitting position significantly improved LP success rates (63.7% vs. 57.6%; p=0.029), while stylet removal timing had no impact. Additionally, sitting position was associated with fewer desaturations and better procedural tolerance.

Conclusion: Sitting position enhances neonatal LP success, is safe, cost-neutral, and should be adopted as the standard technique. Further research is needed for preterm and older infants.

Keywords: Neonatal lumbar puncture, Sitting position, Lying position, Stylet removal, Neonatal procedure, Cerebrospinal fluid analysis