O2174: First In-human Pilot Study of Broadband Optical Spectroscopy as Noninvasive Surveillance for Necrotizing Enterocolitis

Background: Necrotizing enterocolitis (NEC) lacks predictive biomarkers and objective early diagnostic criteria. A transcutaneous noninvasive system for broadband optical spectroscopy (BOS) was previously demonstrated in a mouse model of NEC to have diagnostic specificity and early predictive power. Here, in continuation of the translational development, we report a first-in-human observational study in premature infants.

Methods: An apparatus for BOS in infants was assembled comprising a handheld probe with broad-spectrum light source coupled to a laboratory-grade spectrometer (ASD LabSpec 4, Malvern Panalytical), with detection range of 350-2500 nm (Figure 1). Inclusion criteria were premature neonates fewer than 36 weeks of gestation without congenital cardiac conditions or abdominal wall defects. Study protocol was approved by the IRB (2019-3011).

Results: One hundred infants were enrolled over a 3-year period in two large affiliated neonatal intensive care units. Daily four-quadrant abdominal measurements were obtained in under 2 minutes at the time of routine nursing care. Neither patient harm nor impediments to clinical treatment were noted. Reliable infrared reflectance signals of intra-abdominal intestine were acquired from infants of all skin tones. Ten infants developed Bell Stage 2 (moderate) or 3 (severe) NEC during the study and another four had a spontaneous intestinal perforation or other intra-abdominal process. At the time of NEC, BOS demonstrated noticeably different visible reflectance patterns compared to measurements taken from the same infants in their usual state of health. (Figure 2).

Conclusion: BOS is a feasible, noninvasive technology for point-of-care assessment of newborn intestinal ischemia. The presence of signal changes in premature infants under 2 kg with severe NEC suggests that BOS is promising as a viable modality of early detection.