1. Andrew M. Ellefson, MD Neonatologist Christiana Care Health System
T.I.M.E. (Triple I to Manage Early-onset Sepsis): Changing our Management of Mothers and Their Newborns
Andrew M. Ellefson, MD
Neonatologist
Christiana Care Health System

2. FROM CHORIOAMNIONITIS: TO T.I.M.E. PATHWAY
CHANGING OUR MANAGEMENT OF
MOTHERS AND THEIR NEWBORNS

3. Current State- CDC/COFN Guidelines
All infants born to mothers with a diagnosis of “chorioamnionitis” are admitted to the NICU; regardless of absence of symptoms.
Blood culture on admission and CBC monitoring
Minimum 48 hrs of ampicillin/gentamicin
Diagnosis of chorioamnionitis sometimes loosely applied.
Maternal fever > 37.8° C and:
Significant maternal tachycardia (>120 beats/min)
Fetal tachycardia (> beats/min)
Purulent or foul-smelling amniotic fluid or vaginal discharge
Uterine tenderness
Maternal leukocytosis (total blood leukocyte count >15,000-18,000 cells/μL)

4. Impact of “r/o sepsis chorio” admissions
Asymptomatic Infant admitted for 48 hrs to ICN:
Mother/baby separation
Reduction in bonding
Increased parental stress/anxiety
Reduction in maternal breast milk production and feeding
Increased exposure to formula and IV fluids
Unnecessary lab draws
Risk for extended hospitalization
due to “culture negative” prolonged antibiotic use due to non-specific CBC lab abnormalities
Weaning off of IVFs
Adverse Events -
IV infiltrates
Dollars
$500/patient hospital day compared to admission to mother/baby unit
Based on CCHS 2015 “chorio admission” data, this would be
~ $86, ,000/year
For adverse events, a study by researchers at Johns Hopkins in 1983 found that 20% of febrile neonates less than 60 days old who were admitted for rule out sepsis experienced a medical error, including gentamicin overdosing or IV fluid infiltration.
So you can see, the treatment for “chorio” is not necessarily a benign path to pursue. As mentioned, the CDC and COFN guidelines don’t distinguish between well or ill appearing when the decision is made to rule out sepsis and start antibiotics.

5. Click Link Below for OB’s “Triple-I” reference
Bottom Line
Evidence strongly supports modifying how we manage babies born to mothers with chorioamnionitis by using a more EBM approach.
Emphasis should be on the neonatal clinical exam and maternal risk factors as a whole, not isolated factors taken separately.
*A detailed list of references, slides, and segments from Dr. Ellefson’s Peds Grand Rounds on this topic are included at end of this presentation.
Click Link Below for OB’s “Triple-I” reference
Higgins RD, Saade G, Polin RA, et al. Evaluation and Management of Women and Newborns With a Maternal Diagnosis of Chorioamnionitis: Summary of a Workshop. Obstet Gynecol 2016; 127:426.

6. T.I.M.E. PATHWAY
T = Triple
I = Intrauterine Inflammation and/or Infection
M = Manage
E = Early onset Sepsis

7. TRIPLE I CLINICAL DIAGNOSIS
Clinical findings
Documented Maternal fever
PLUS ONE OF THE FOLLOWING VARIABLES:
Fetal Tachycardia (>160 for 10 minutes)
Purulent Discharge from the cervical OS
“Left shift in WBC”/WBC’s . 15,000

8. Peds/DR provider fills out the rest
L&D Nurse Process Flow
Power Form Completion
2. Record Sepsis Calculator Clinical Recommendations. *Fill in all that apply from the calculator
1. Record newborn 30 min vitals
3. Notify Peds DR team/provider and document who was notified.
4. Complete form.
5. Sign form.
Peds/DR provider fills out the rest

9. L&D Nurse/Peds DR Provider IMPORTANT Points
Peds/DR provider should be at all deliveries if there is a concern for fetal well being.
Peds/DR does not need to be at all deliveries if the mother only had an isolated fever. But, these babies still need a Sepsis Calculator score completed after delivery.
Call Peds/DR provider to notify them of mothers with fevers (when able to do so) and then also after the Sepsis Calculator has been completed for the newborn (if Peds not present for delivery).
Call Peds/DR provider if there is concern for newborn instability or vitals abnormality (ie: tachypnea).
Peds/DR provider should assess all babies with any sign of clinical instability (ie: tachypnea).

10. L&D Nurse/Peds DR Provider IMPORTANT Points
If the baby appears to be stable and is demonstrating normal transitional physiology (ie: comfortable tachypnea), he/she may remain with the mother per routine in L&D.
The baby can always be brought to the NICU for OBS if indicated.
“Equivocal” exam babies, by definition in attached slide, require 2-4 hours of persistent symptoms. Therefore, a comfortably tachypnea baby at 1 HOL may simply be demonstrating transitional physiology and does not necessarily meet criteria for “equivocal exam”. If concerned, discuss with Peds/DR or Neonatology.
When the mother is ready for transfer to Well Baby floor, only “Well Appearing” babies who do not require NICU admission (per their Sepsis Calc recs) are cleared for co-transfer to Well Baby floor. Any baby with ongoing transitional physiologic abnormalities, or any sign of distress must go to the NICU.
If a baby goes to NICU for OBS and then has complete resolution of symptoms, clinical discretion can be used to allow this baby to return to Well Baby Floor with mother.
The Peds/DR provider must notify the Well Baby physician or covering provider about the baby’s Sepsis Calc recommendation and clinical disposition. This will ensure proper physician-physician hand off. The L&D nurse must also report this information in their handoff to post-partum nursing. It is important to note that these babies will have Q4hr vitals on Well Baby floor for 48 hrs and that there must be a low threshold to transfer from floor to NICU at the earliest sign of new/developing distress.

11. Kaiser Permanente Sepsis Risk Score Calculator
Clinical Exam Description

12. Newborn Physician / Well Baby Nurse Alert
Occurs the first time any Nurse or Provider opens chart on PP
As long as Newborn has active tag.

13. Well Baby Floor: Process Flow
Vitals signs on admission.
Vital signs 1 hour after admission to floor, and then Q4hr until 48 hours of life.
Nurse gets alert to review Neonatal Sepsis Calculator Form on baby Daily until 48 hours of life
Well Baby/Newborn Physician gets alert to review Neonatal Sepsis Calculator Form on baby Daily until 48 hours of life

14. Well Baby Nurse Process Flow

15. Newborn Physician / Well Baby Nurse Alert
Reminds Well Baby Nurse and Physician Provider to review the Neonate Sepsis Calculator Form document.

16. Well Baby Floor Documentation on Chart

17. Key Issues to Remember
The goal is to reduce unnecessary admissions to the NICU.
Safety is key to making this successful.
Any Well Baby/Floor newborn with any possible sign of distress needs to be discussed with NICU team and the covering well baby doctor.
Don’t delay in transferring a baby to the NICU who has abnormal vitals or signs of distress.

18. Click Link Below for OB’s “Triple-I” reference
References
Taylor JA, Opel DJ. Choriophobia: a 1-act play. Pediatrics Aug;130(2):342-6.
Verani JR, McGee L, Schrag SJ; Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). Prevention of perinatal group B streptococcal disease—revised guidelines from CDC, MMWR Recomm Rep. 2010;59(RR-10):1–36.
Stoll BJ, Hansen NI, Sánchez PJ, Faix RG, Poindexter BB, Van Meurs KP, Bizzarro MJ, Goldberg RN, Frantz ID 3rd, Hale EC, Shankaran S, Kennedy K, Carlo WA, Watterberg KL, Bell EF, Walsh MC, Schibler K, Laptook AR, Shane AL, Schrag SJ, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues. Pediatrics May;127(5):
Shakib B, Buchi K, Smith E, Young PC. Management of Newborns Born to Mothers with Chorioamnionitis: Is It Time for a Kinder, Gentler Approach. Acad. Pediatrics 2015;15:
Puopolo KM, Draper D, Wi S, Newman TB, Zupancic J, Lieberman E, Smith M, Escobar GJ. Estimating the probability of neonatal early-onset infection on the basis of maternal risk factors. Pediatrics 2011;128:e
Escobar GJ, Li DK, Armstrong MA, et al. Neonatal sepsis workups in infants >/2000 grams at birth: A population-based study. Pediatrics. 2000;106 (2 pt 1):
Escobar GJ, Puopolo KM, Wi S, Turk BJ, Kuzniewicz MW, Walsh EM, Newman TB, Zupancic J, Lieberman E, Draper D. Stratification of risk of early-onset sepsis in newborns > 34 weeks' gestation. Pediatrics 2014;133:30-6.
Higgins RD, Saade G, Polin RA, Grobman WA, Buhimschi IA, Watterberg K, Silver RM, Raju TN. Evaluation and Management of Women and Newborns With a Maternal Diagnosis of Chorioamnionitis: Summary of a Workshop. Obstet Gynecol 2016 Mar;127(3):
Polin R, Watterberg K, Benitz W, Eichenwald E. The Conundrum of Early Onset Sepsis. Pediatrics 2014;133:1122.
Management of the infant at increased risk for sepsis. Paediatrics & Child Health. 2007;12(10):
Sagori M, Puopolo KM. Neonatal Early-Onset Sepsis: Epidemiology and Risk Assessment. NeoReviews Apr 2015, 16 (4) e221-e230; DOI: /neo.16-4-e221
Click Link Below for OB’s “Triple-I” reference
Higgins RD, Saade G, Polin RA, et al. Evaluation and Management of Women and Newborns With a Maternal Diagnosis of Chorioamnionitis: Summary of a Workshop. Obstet Gynecol 2016; 127:426.

20. Pathway Overview (cont)