# US 10,869,637 B2 · Method, system, and computer readable medium for generating pulse oximetry predictive scores (POPS) for predicting adverse outcomes in preterm infants

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- Number: US 10,869,637 B2
- Document ID: US10869637B2
- Status: Granted
- Kind: B2
- Application number: 15/801,226
- Filed: 2017-11-01
- Published: 2018-03-15
- Granted: 2020-12-22
- Earliest claimed: 2016-05-02
- Assignees: University of Virginia Patent Foundation
- Applicants: University of Virginia Patent Foundation
- Inventors: Karen D. Fairchild; Douglas E. Lake; Brynne Sullivan
- Web page: https://patentgrep.com/patent/US10869637B2

## CPC

- A61B 5/7275: {Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor}
- A61B 5/1455: using optical sensors, e.g. spectral photometrical oximeters
- A61B 5/14551: {for measuring blood gases}
- A61B 5/48: {Other medical applications}
- G16H 50/30: for calculating health indices; for individual health risk assessment
- A61B 2503/045: Newborns, e.g. premature baby monitoring
- A61M 2230/205: partial oxygen pressure (P-O2)
- G16H 15/00: ICT specially adapted for medical reports, e.g. generation or transmission thereof
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A method and system for generating pulse oximetry predictive scores for predicting adverse outcomes in preterm infants.

## Claims

### Claim 1

A method for generating pulse oximetry predictive scores (POPS) for predicting occurrence of predetermined pathologies in a preterm infant, the method comprising:
receiving in at least one processor Heart Rate (HR) and oxygen saturation (SpO2) data collected from the preterm infant with a pulse oximetry sensor;
calculating by said at least one processor mean and standard deviation of HR and SpO2, cross-correlation of HR and SpO2, HR decelerations, HR and SpO2 entropy, hypoxia and hyperoxia from said received HR and SpO2 data, wherein the calculations are made over different time periods specific to a predetermined pathology;
generating by said at least one processor pulse oximetry predictive scores with a predictive algorithm which incorporates a cross-correlation of HR and SpO2 based on archived pulse oximetry data of multiple preterm infants to analyze the calculated data;
outputting said generated pulse oximetry predictive scores (POPS) on an output device to a user;
predicting the predetermined pathology of said preterm infant based on the generated POPS, wherein the pathology includes at least one of intraventricular hemorrhage (IVH), late-onset sepsis (LOS), necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD), or retinopathy of prematurity (ROP); and
based on the outputted POPS, performing an action selected from the group of:
identifying said preterm infant as a highest risk infant and performing additional surveillance of or therapeutic intervention on said preterm infant;
identifying said preterm infant for participation in a clinical trial based on a risk profile associated with said POPS; and
treating said preterm infant for said pathology.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the time periods are based on death or intraventricular hemorrhage (IVH) at first 24 hour or shorter time periods, after birth.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the time periods are based on sepsis or necrotizing enterocolitis (NEC) at 2 days leading up to clinical diagnosis, including increase over patient baseline or increase over population normal.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the time periods are based on bronchopulmonary dysplasia (BPD) or retinopathy of prematurity (ROP) at first day, week, or month.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the time periods are based on prolonged Neonatal Intensive Care Unit (NICU) stay at first day, week, or month.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the predictive algorithm additionally incorporates gestational age, birth weight, and post-menstrual age.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the data collected from the preterm infant further includes specific laboratory values, including white blood cell count, hematocrit, and C-reactive protein.

### Claim 8 (depends on 7)

The method according to claim 7, wherein the predictive algorithm additionally incorporates standard demographic risk factors to determine risk of early or late death or prolonged Neonatal Intensive Care Unit (NICU) stay.

### Claim 9 (depends on 1)

The method according to claim 1, including monitoring changes in cardiorespiratory changes occurring in the preterm infant with systemic inflammation related to late-onset septicemia (LOS) or necrotizing enterocolitis (NEC), and alerting clinicians before overt signs of illness emerges.

### Claim 10 (depends on 9)

The method according to claim 9, including monitoring respiratory rate (RR), heart rate (HR), and oxygen saturation (SpO2) of the preterm infant.

### Claim 11 (depends on 1)

The method according to claim 1, including monitoring changes in vital sign patterns of the preterm infant.

### Claim 12 (depends on 11)

The method according to claim 11, wherein monitoring data is collected using a server.

### Claim 13 (depends on 12)

The method according to claim 12, wherein the monitoring data includes respiration rate (RR) derived from a chest impedance signal, heart rate (HR) derived from an electrocardiogram (ECG) signal, and oxygen saturation (SpO2) derived from a pulse oximeter, and the monitoring data is collected every 2 seconds.

### Claim 14 (depends on 13)

The method according to claim 13, wherein maximum cross-correlation between two vital sign signals is calculated over ten-minute windows by first standardizing each signal and then using a MATLAB® function XCORR, with a lag time of −30 to +30 seconds.