First-in-human pilot study of broadband optical spectroscopy (BOS) as noninvasive surveillance for necrotizing...

Necrotizing enterocolitis (NEC) lacks predictive biomarkers and objective early diagnostic markers. Broadband optical spectroscopy (BOS), a transcutaneous noninvasive tool, has previously demonstrated diagnostic specificity and early predictive power for NEC in a mouse model. Here, in continuation of the translational development, we report a first-in-human observational study in premature infants.

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. Inclusion criteria were premature neonates fewer than 36 weeks of gestation without congenital cardiac conditions or abdominal wall defects. Readings were graphed for descriptive comparison and analyzed via support vector machine supervised computer learning.

96 infants were enrolled over a 3-year period in two large neonatal intensive care units. Four-quadrant abdominal measurements were obtained in under 2 min at the time of routine nursing care. Neither patient harm nor any impediments to clinical treatment were noted. Reliable infrared reflectance signals of intra-abdominal intestine were acquired from infants of all Fitzpatrick 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 identified intraabdominal process. BOS measurements taken during active NEC episodes were visibly different than same-infant readings and could be retrospectively identified with over 90 % sensitivity and specificity in a machine learning model.

BOS is a safe, feasible, noninvasive technology for point-of-care assessment of NEC. The presence of detectable signal changes in premature infants with Bell Stage 2 or 3 NEC suggests that BOS shows promise as a modality of screening or early detection in this vulnerable population.