MAGNETIC NON-INVASIVE AURICULAR ACUPUNCTURE DURING EYE-EXAM FOR RETINOPATHY OF PREMATURITY IN PRETERM INFANTS: A MULTICENTRE RANDOMIZED CONTROLLED TRIAL

Abstract

Background:Retinopathy of Prematurity (ROP) examinations are essential for early detection of vision-threatening disease in preterm infants but are associated with significant procedural pain and physiological stress. Current pharmacological and non-pharmacological analgesic measures offer limited efficacy or carry safety concerns. Magnetic Non-invasive Auricular Acupuncture (MNAA) has emerged as a potential complementary strategy to alleviate procedural pain without the risks associated with systemic analgesics.

Methods:This multicenter, parallel group, randomized controlled trial enrolled 200 preterm infants (gestational age <37 weeks) scheduled for routine ROP screening across multiple tertiary neonatal intensive care units. Infants were randomized in a 1:1 ratio to either the MNAA intervention group or the control group receiving standard care. MNAA involved application of magnetic pellets to specific auricular acupoints 30 minutes before the examination. The primary outcome was procedural pain assessed by Premature Infant Pain Profile (PIPP) scores at baseline, during, and after the examination. Secondary outcomes included heart rate, oxygen saturation, respiratory rate, adverse events, and caregiver/clinician satisfaction.

Results:Baseline gestational age and birth weight were comparable between groups (p = 0.618 and p = 0.812, respectively). The MNAA group exhibited significantly lower PIPP scores during (6.9 ± 1.7 vs. 9.2 ± 2.0; p < 0.001) and after (4.7 ± 1.4 vs. 7.1 ± 1.6; p < 0.001) the ROP examination compared to controls. Physiological markers also favored the MNAA group, with significantly lower heart rates (p = 0.003), higher oxygen saturations (p = 0.004 during examination; p = 0.009 post-exam), and reduced respiratory rates (p = 0.002 during examination; p = 0.014 post-exam). No adverse events were reported, and both clinician and parent satisfaction levels were high and comparable between groups.

Conclusion:Magnetic Non-invasive Auricular Acupuncture is a safe, effective, and well-tolerated adjunct for reducing procedural pain and physiological stress during ROP examinations in preterm infants. MNAA holds promise for improving procedural care in this vulnerable population and warrants further research into its long-term neurodevelopmental impact and integration into standard neonatal pain management protocols.