Clinical effectiveness and safety of laser lancing for heel puncture in preterm infants: a randomized crossover non-inferiority trial.

OBJECTIVE

To evaluate the clinical effectiveness and safety of laser-lancing devices (LLDs) compared with an automatic incision device (AID) for heel puncture in preterm infants.

STUDY

DESIGN

A randomized crossover non-inferiority trial was conducted in 40 preterm infants between April and December 2021. Primary outcomes were procedural success rate, pain response assessed by the Premature Infant Pain Profile (PIPP), and skin penetration depth.

RESULTS

LLD achieved a 75% first-attempt success rate, reaching 100% after a second attempt at a higher energy setting, whereas AID achieved 100% success on the first attempt. PIPP scores during the procedure were significantly lower with LLD than with AID (4.5 [3.0-6.0] vs. 6.5 [4.0-7.5]; P = 0.014). Penetration depths were similar between devices (1.21 ± 0.30 vs. 1.25 ± 0.23 mm).

CONCLUSIONS

LLD appears to be non-inferior to AID in terms of effectiveness and safety for heel puncture in preterm infants, with reduced procedural pain.

CLINICAL TRIAL REGISTRATION: Clinical Research Information Service (Registration No. KCT0010932).