NeoCLEAR

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

Trial started: 2017  Trial ended: 2020 

Summary

Objectives

To compare two modifications to standard lumbar puncture technique, that is, use of the lying position rather than the sitting position and 'early' rather than 'late' stylet removal, in terms of success rates and short-term clinical, resource and safety outcomes.

Methods

A multicentre 2 × 2 factorial pragmatic non-blinded randomised controlled trial. Infants requiring lumbar puncture (working weight ?1000 g and corrected gestational age 27+0 to 44+0 weeks), whose parents provided written consent, were randomised to lumbar puncture (1) in the sitting or lying position and (2) with early or late stylet removal.

Outcome measures

Primary outcome: Successful lumbar puncture, defined as cerebrospinal fluid containing <10,000 red cells/mmł.

Results

Of 1082 infants randomised (sitting with early stylet removal, n = 275; sitting with late stylet removal, n = 271; lying with early stylet removal, n = 274; lying with late stylet removal, n = 262), 1076 were followed up until discharge. Most infants were term born (950/1076, 88.3%), were aged <3 days (936/1076, 87.0%) and had a working weight >2.5 kg (971/1076, 90.2%). Baseline characteristics were balanced across groups. The sitting position was significantly more successful than the lying position [346/543 (63.7%) vs 307/533 (57.6%); adjusted risk ratio 1.10, 95% confidence interval 1.01 to 1.21; p = 0.029; number needed to treat = 16 (95% confidence interval 9 to 134)]. There was no significant difference in the primary outcome between early and late stylet removal [338/545 (62.0%) vs 315/531 (59.3%); adjusted risk ratio 1.04, 95% confidence interval 0.94 to 1.15; p = 0.447]. Resource consumption was similar in all groups, and all techniques were well tolerated and safe.

Conclusions

Lumbar puncture success rate was higher with infants in the sitting position but was not affected by timing of stylet removal. Lumbar puncture was safe, well tolerated, simple, without additional cost, and easily learned and applied. The results support a paradigm shift towards the sitting technique as the standard position for neonatal lumbar puncture, especially for term-born infants during the first 3 days of life.

Adapted from: Roehr CC, Marshall ASJ, Scrivens A, et al. Techniques to increase lumbar puncture success in newborn babies: the NeoCLEAR RCT. Health Technology Assessment. 2023;27(33). https://doi.org/10.3310/THJY0671. Licensed under the Creative Commons Attribution 4.0 International (CC BY 4.0) Licence (https://creativecommons.org/licenses/by/4.0/). Adapted for presentation on this website.