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 an effective and safe alternative to AID for heel puncture in preterm infants, with reduced procedure pain. CLINICAL TRIAL REGISTRATION: Clinical Research Information Service (Registration No. KCT0010932)