The Influence of Mediators on the Relationship Between Antenatal Opioid Agonist Exposure and the Severity of Neonatal Opioid Withdrawal Syndrome.

OBJECTIVES: (1) To evaluate the direct (un-mediated) and indirect (mediated) relationship between antenatal exposure to opioid agonist medication as treatment for opioid use disorder (MOUD) and the severity of neonatal opioid withdrawal syndrome (NOWS), and (2) to understand the degree to which mediating factors influence the direct relationship between MOUD exposure and NOWS severity. METHODS: This cross-sectional study includes data abstracted from the medical records of 1294 opioid-exposed infants (859 MOUD exposed and 435 non-MOUD exposed) born at or admitted to one of 30 US hospitals from July 1, 2016, to June 30, 2017. Regression models and mediation analyses were used to evaluate the relationship between MOUD exposure and NOWS severity (i.e., infant pharmacologic treatment and length of newborn hospital stay (LOS)) to identify potential mediators of this relationship in analyses adjusted for confounding factors. RESULTS: A direct (un-mediated) association was found between antenatal exposure to MOUD and both pharmacologic treatment for NOWS (aOR 2.34; 95%CI 1.74, 3.14) and an increase in LOS (1.73 days; 95%CI 0.49, 2.98). Delivery of adequate prenatal care and a reduction in polysubstance exposure were mediators of the relationship between MOUD and NOWS severity and as thus, were indirectly associated with a decrease in both pharmacologic treatment for NOWS and LOS. CONCLUSIONS FOR PRACTICE: MOUD exposure is directly associated with NOWS severity. Prenatal care and polysubstance exposure are potential mediators in this relationship. These mediating factors may be targeted to reduce the severity of NOWS while maintaining the important benefits of MOUD during pregnancy.

A Longitudinal Study of a Multifaceted Intervention to Reduce Newborn Falls While Preserving Rooming-In on a Mother-Baby Unit.

BACKGROUND: Newborn falls occur when newborns held by caregivers slip from hands or arms and land on another surface. Though injury is rare, The Joint Commission has highlighted newborn falls as a patient safety priority. One hospital sought to reduce newborn falls to fewer than 10 per 10,000 births, to achieve 365 days without a fall, and to reduce injuries from falls to zero, while preserving mother-baby rooming-in. METHODS: An interprofessional quality improvement team developed and implemented prevention measures after three falls occurred in a two-month period. The team performed root cause analysis (RCA) of events and 10 in-depth chart reviews, and developed and implemented parent education materials, a nursing risk assessment tool and job aid, and a standardized reporting system. Outcomes were measured using statistical process control methods for rare events. RESULTS: In early 2017 the hospital's newborn fall rate increased to 71.8 falls per 10,000 births, with 3 falls occurring in a two-month period. RCA and chart review found sustained prenatal maternal opioid intake in 4 of 10 cases. Mechanism of fall differed by mode of delivery, with more drops by a sleeping caregiver following vaginal deliveries and falls due to maternal trips after cesarean deliveries. After interventions, the fall rate decreased to 15.5 per 10,000 births. Days between falls increased from a low of 9 days to a high of 467 days. No newborn injuries have occurred since early 2017. CONCLUSION: A series of interventions, including parent education, nursing practices, and attention to physical layout, was associated with reduced newborn falls and elimination of fall-related injuries while preserving rooming-in on a mother-baby unit with many opioid-exposed newborns.

Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome.

BACKGROUND AND OBJECTIVES: Despite the neonatal opioid withdrawal syndrome (NOWS) epidemic in the United States, evidence is limited for pharmacologic management when first-line opioid medications fail to control symptoms. The objective with this study was to evaluate outcomes of infants receiving secondary therapy with phenobarbital compared with clonidine, in combination with morphine, for the treatment of NOWS. METHODS: We performed a retrospective cohort study of infants with NOWS from 30 hospitals. The primary outcome measures were the length of hospital stay, duration of opioid treatment, and peak morphine dose. Outcomes were compared by group by using analysis of variance and multivariable linear regression controlling for relevant confounders. RESULTS: Of 563 infants with NOWS treated with morphine, 32% (n = 180) also received a secondary medication. Seventy-two received phenobarbital and 108 received clonidine. After adjustment for covariates, length of hospital stay was 10 days shorter, and, in some models, duration of morphine treatment was 7.5 days shorter in infants receiving phenobarbital compared with those receiving clonidine, with no difference in peak morphine dose. Infants were more likely to be discharged from the hospital on phenobarbital than clonidine (78% vs 29%, P < .0001). CONCLUSIONS: Among infants with NOWS receiving morphine and secondary therapy, those treated with phenobarbital had shorter length of hospital stay and shorter morphine treatment duration than clonidine-treated infants but were discharged from the hospital more often on secondary medication. Further investigation is warranted to determine if the benefits of shorter hospital stay and shorter duration of morphine therapy justify the possible neurodevelopmental consequences of phenobarbital use in infants with NOWS.

Site-Level Variation in the Characteristics and Care of Infants With Neonatal Opioid Withdrawal.

BACKGROUND AND OBJECTIVES: Variation in pediatric medical care is common and contributes to differences in patient outcomes. Site-to-site variation in the characteristics and care of infants with neonatal opioid withdrawal syndrome (NOWS) has yet to be quantified. Our objective was to describe site-to-site variation in maternal-infant characteristics, infant management, and outcomes for infants with NOWS. METHODS: Cross-sectional study of 1377 infants born between July 1, 2016, and June 30, 2017, who were ≥36 weeks' gestation, with NOWS (evidence of opioid exposure and NOWS scoring within the first 120 hours of life) born at or transferred to 1 of 30 participating hospitals nationwide. Site-to-site variation for each parameter within the 3 domains was measured as the range of individual site-level means, medians, or proportions. RESULTS: Sites varied widely in the proportion of infants whose mothers received adequate prenatal care (31.3%-100%), medication-assisted treatment (5.9%-100%), and prenatal counseling (1.9%-75.5%). Sites varied in the proportion of infants with toxicology screening (50%-100%) and proportion of infants receiving pharmacologic therapy (6.7%-100%), secondary medications (1.1%-69.2%), and nonpharmacologic interventions including fortified feeds (2.9%-90%) and maternal breast milk (22.2%-83.3%). The mean length of stay varied across sites (2-28.8 days), as did the proportion of infants discharged with their parents (33.3%-91.1%). CONCLUSIONS: Considerable site-to-site variation exists in all 3 domains. The magnitude of the observed variation makes it unlikely that all infants are receiving efficient and effective care for NOWS. This variation should be considered in future clinical trial development, practice implementation, and policy development.

A quality improvement initiative to implement the eat, sleep, console neonatal opioid withdrawal syndrome care tool in Massachusetts' PNQIN collaborative.

OBJECTIVE: To support hospitals in the Massachusetts PNQIN collaborative with adoption of the ESC Neonatal Opioid Withdrawal Syndrome (NOWS) Care Tool© and assess NOWS hospitalization outcomes. STUDY DESIGN: Statewide QI study where 11 hospitals adopted the ESC NOWS Care Tool©. Outcomes of pharmacotherapy and length of hospital stay (LOS) and were compared in Pre- and Post-ESC implementation cohorts. Statistical Process Control (SPC) charts were used to examine changes over time. RESULTS: The Post-ESC group had lower rates of pharmacotherapy (OR 0.35, 95% CI 0.26, 0.46) with shorter LOS (RR 0.79, 95% CI 0.76, 0.82). The 30-day NOWS readmission rate was 1.2% in the Pre- and 0.4% in the Post-ESC cohort. SPC charts indicate a shift in pharmacotherapy from 54.8 to 35.0% and LOS from 14.2 to 10.9 days Post-ESC. CONCLUSIONS: The ESC NOWS Care Tool was successfully implemented across a state collaborative with improvement in NOWS outcomes without short-term adverse effects.

Models of care for neonatal abstinence syndrome: What works?

Opioid use disorders and the prescription of long-acting medications for their treatment have increased dramatically over the last decade among pregnant women. Newborns who experience prolonged in utero opioid exposure may develop neonatal abstinence syndrome (NAS). Until recently, much of the focus on improving care for NAS has been on pharmacologically-based care models. Recent studies have illustrated the benefits of rooming-in and parental presence on NAS outcomes. Single center Quality Improvement (QI) initiatives demonstrate the benefits of non-pharmacologic care bundles and symptom prioritization in decreasing the proportion of infants pharmacologically treated and length of hospital stay. Little remains known about the impact of these varied cared models on maternal-infant attachment and mental health. In this review article, we will propose an optimal model of care to improve short- and long-term outcomes for newborns, their mothers and families, and perinatal care systems.

Breastmilk feeding for mothers and infants with opioid exposure: What is best?

With rare exception, breastfeeding is the optimal way to feed infants, and has special benefits for women and infants with perinatal opioid exposure. Infants breastfed and/or fed their mother's own breastmilk experience less severe opioid withdrawal symptoms, have shorter hospital stays, and are less likely to be treated with medication for withdrawal. The specific impact of mothers' milk feeding on opioid withdrawal may be related to the act of breastfeeding and associated skin-to-skin contact, qualities of breastmilk, healthier microbiome, small amounts of opioid drug in breastmilk, or a combination of these. Women with opioid use disorder face significant breastfeeding obstacles, including psychosocial, behavioral, concomitant medications, and tobacco use and thus may require high levels of support to achieve their breastfeeding goals. They often don't receive information to make informed infant feeding decisions. Hospital practices such as prenatal education, rooming-in and having a policy that minimizes barriers to breastfeeding are associated with increased breastfeeding rates.

Quality improvement initiative to improve inpatient outcomes for Neonatal Abstinence Syndrome.

OBJECTIVES: To improve Neonatal Abstinence Syndrome (NAS) inpatient outcomes through a comprehensive quality improvement (QI) program. DESIGN: Inclusion criteria were opioid-exposed infants ≥36 weeks. QI methodology including stakeholder interviews and plan-do-study-act (PDSA) cycles were utilized. We compared pre- and post-intervention NAS outcomes after a QI initiative that included: A non-pharmacologic care bundle, function-based assessments consisting of symptom prioritization and then the "Eat, Sleep, Console" (ESC) Tool; and a switch to methadone for pharmacologic treatment. RESULTS: Pharmacologic treatment decreased from 87.1 to 40.0%; adjunctive agent use from 33.6 to 2.4%; hospitalization length from a mean 17.4 to 11.3 days, and opioid treatment days from 16.2 to 12.7 (p < 0.001 for all). Total hospital charges decreased from $31,825 to $20,668 per infant. Parental presence increased from 55.6 to 75.8% (p < 0.0001). No adverse events were noted. CONCLUSIONS: A comprehensive QI program focused on non-pharmacologic care, function-based assessments, and methadone resulted in significant sustained improvements in NAS outcomes. These findings have important implications for establishing potentially better practices for opioid-exposed newborns.

Wide Variation Found in Care of Opioid-Exposed Newborns.

OBJECTIVE: Standardized practices for the management of neonatal abstinence syndrome (NAS) are associated with shorter lengths of stay, but optimal protocols are not established. We sought to identify practice variations for newborns with in utero chronic opioid exposure among hospitals in the Better Outcomes Through Research for Newborns (BORN) network. METHODS: Nursery site leaders completed a survey about hospitals' policies and practices regarding care for infants with chronic opioid exposure (≥3 weeks). RESULTS: The 76 (80%) of 95 respondent hospitals were in 34 states, varied in size (<500 to >8000 births and <10 to >200 opioid-exposed infants per year), with most affiliated with academic centers (89%). Most (80%) had protocols for newborn drug exposure screening; 90% used risk-based approaches. Specimens included urine (85%), meconium (76%), and umbilical cords (10%). Of sites (88%) with NAS management protocols, 77% addressed medical management, 72% nursing care, 72% pharmacologic treatment, and 58% supportive care. Morphine was the most common first-line pharmacotherapy followed by methadone. Observation periods for opioid-exposed newborns varied; 57% observed short-acting opioid exposure for 2 to 3 days, while 30% observed for ≥5 days. For long-acting opioids, 71% observed for 4 to 5 days, 19% for 2 to 3 days, and 8% for ≥7 days. Observation for NAS occurred mostly in level 1 nurseries (86%); however, most (87%) transferred to NICUs when pharmacologic treatment was indicated. CONCLUSIONS: Most BORN hospitals had protocols for the care of opioid-exposed infants, but policies varied widely and characterized areas of needed research. Identification of variation is the first step toward establishing best practice standards to improve care for this rapidly growing population.

The New Hampshire Ten Steps to Successful Breastfeeding Collaborative: A Statewide QI Initiative.

BACKGROUND AND OBJECTIVE: Despite national recognition for their breastfeeding-friendly practices, many New Hampshire hospitals are still not achieving the Ten Steps to Successful Breastfeeding. To increase achievement of the Ten Steps in New Hampshire's birthing hospitals, facilitate Baby-Friendly Hospital Initiative (BFHI) designation for interested hospitals, and improve rates of in-hospital any and exclusive breastfeeding. METHODS: After a 2010 needs assessment, we conducted 2 statewide workshops targeting 6 of the Ten Steps found to be most deficient among New Hampshire birthing hospitals. Eighteen of 20 hospitals attended at least 1 workshop, and 6 participated in an intensive collaborative. In 2013, we analyzed interval Ten Step achievement and in-hospital breastfeeding trends. RESULTS: Staff education showed the greatest improvement, increasing step 2 achievement from 1 to 6 hospitals (P=.05). Although the number of hospitals implementing step 6 (breast milk only) and step 9 (no artificial nipples) increased, differences were not statistically significant. Intensive collaborative hospitals achieved an average of 1.5 new steps, whereas non-Baby Friendly hospitals lost 0.7 steps (P=.05). In-hospital breastfeeding rates increased in intensive collaborative hospitals and were significantly higher than those in non-Baby Friendly hospitals by the end of the study (any breastfeeding, 89% vs 73%, P=.03; exclusive breastfeeding, 84% vs 61%, P<.001). CONCLUSIONS: A statewide improvement collaborative facilitated increases in Ten Step achievement and in-hospital breastfeeding for hospitals participating in an intensive collaborative. Active work in Ten Step implementation, including staff education, appears to be more effective in increasing in-hospital breastfeeding than does BFHI designation alone.

How to use: transcutaneous bilirubinometry.

The National Institute for Health and Clinical Excellence neonatal jaundice guidelines recommend checking the bilirubin level in all infants with visible jaundice. The gold standard for this measurement is total serum bilirubin (TSB). Transcutaneous bilirubinometry (TcB) is an alternative to TSB that has been validated for clinical use through extensive study. TcB provides many advantages over TSB including instantaneous measurements without requiring a painful lab draw. For infants >35 weeks gestation, TcB can reliably identify infants at risk for severe hyperbilirubinaemia and can decrease the number of TSB measurements obtained. However, paediatric providers should be aware of limitations in clinical use of TcB including decreasing accuracy at higher bilirubin levels, lack of independently validated nomograms for interpretation and limited research regarding its use during phototherapy.