Professor of Perinatal Medicine Brighton and Sussex Medical School Brighton, England, United Kingdom
Background: Excessive or persistent apnoea resulting in intermittent hypoxia and bradycardia is associated with long-term neurodevelopmental problems in premature newborns. Previous research showed promising results using a prototype device providing proprioceptive neurostimulation to reduce apnoeic episodes. The device was further developed by Inspiration Healthcare Ltd for clinical practice. The WAVE device applies a mild transcutaneous vibration to the soles of the foot and palms, using proprioceptor sensors to reflexively activate brain areas controlling breathing Objective: The study’s primary objective was to compare the cumulative duration of breathing pauses related to apnoea of prematurity between periods of presence and absence of tactile vibratory device stimulation adjunct to standard care. Other secondary objectives investigated cumulative duration of desaturation events, bradycardia events, number of apnoea, desaturation, and bradycardia events. Design/Methods: WAVE is a Phase I early feasibility, single blind, randomised sequential assignment interventional crossover design trial in premature newborns, less than 34 weeks gestational age, with apnoea of prematurity using a non-invasive vibratory device. The active and comparative intervention is vibratory device stimulation ON and OFF paired with usual standard of care. Results: 110 babies were screened, and 17 babies were randomised. Analysis of cumulative duration of breathing pauses related to apnoea of prematurity provided similar estimates in the two groups (Ratio OFF/ON = 1.005, p-value = 0.953). In all secondary analyses, there were no differences between group estimates between the OFF and ON periods of study. Comfort and skin assessment scores indicated that discomfort or skin issues were not of concern while using the device. Qualitative results collected in the form of parental and nurses’ questionnaires were positive regarding the device’s acceptability and usability.
Conclusion(s): WAVE study proposed a non-pharmaceutical approach for the treatment of apnoea of prematurity using neuromodulation of proprioceptive fibres to support breathing. Although an effect on reducing the bradycardias and apnoeic episodes was not demonstrated, the device did not cause any adverse effects. The qualitative feedback from parents and carers was positive which supports the device usability and acceptability. Further studies are needed to determine the device efficacy. These should include a larger number of participants with frequent apnoea, robust diagnostic tools for apnoeic episodes and a broader analysis to include shorter episodes of hypoxaemia.
