pmc84052121287Am J PerinatolAm J PerinatolAmerican journal of perinatology0735-16311098-8785404363951224698010.1055/a-2622-3839NIHMS2086022ArticleMaternal Area of Residence and Outcomes for Mother-Infant Dyads with Perinatal Opioid ExposurePahlAdrienneMD1HuZhuopeiMS2YoungLeslie W.MD1RamseyKara WongMD3WhalenBonny L.MD4AkshathaAkshathaMD3BenningerKristen L.MD5FungCamille M.MD6HowellMeghan P.MD7MarkeeSofiaDO8DasAbhikPhD9CrawfordMargaret M.BS9TrochinskiLillianRN, BSN9GreenbergRachel G.MD10SmithBrianMD10OunpraseuthSongthip T.PhD2MerharStephanie L.MD11DevlinLori A.DO12MacMillanKathryn Dee L.MD MPH4for the Eunice Kennedy Shriver NICHD Neonatal Research Network and the NIH ECHO Program IDeA States Pediatric Clinical Trials Network Pediatrics, Robert Larner, M.D., College of Medicine at the University of Vermont Biostatistics, University of Arkansas for Medical Sciences College of Medicine Pediatrics, Kapiolani Medical Center for Women and Children Pediatric Hospital Medicine, Geisel School of Medicine at Dartmouth Pediatrics, Nationwide Children’s Hospital and The Ohio State University Pediatric Neonatology, University of Utah School of Medicine Pediatrics, Tulane University School of Medicine Pediatrics, University of New Mexico Social, Statistical, and Environmental Sciences Unit, RTI International, Research Triangle Park, NC Pediatrics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC Pediatrics, Cincinnati Children’s Hospital Medical Center Pediatrics, University of Louisville School of Medicine

Author contributions: Mr Hu and Dr Ounpraseuth had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design, acquisition, analysis, or interpretation of data: Pahl, Hu, Young, Ounpraseuth, Merhar, Devlin, MacMillan

Drafting of the manuscript: Pahl, Hu, Young, Ramsey, Whalen, Akshatha, Benninger, Fung, Howell, Markee, Das, Crawford, Trochinski, Greenberg, Smith, Ounpraseuth, Merhar, Devlin, MacMillan

Corresponding Author: Adrienne Pahl MD, University of Vermont Larner College of Medicine, Department of Pediatrics, Division of Neonatal – Perinatal Medicine, 111 Colchester Ave, Burlington, VT 05401, Adrienne.Pahl@uvmhealth.org, Fax: (802) 847-85904720252202628520251172025433383395Objective:

Determine the relationship between maternal Social Deprivation Index (SDI), a composite measure of area level deprivation, and maternal characteristics and infant outcomes for mother-infant dyads with perinatal opioid exposure.

Study Design:

Post hoc secondary analysis of 1298 mother-infant dyads in the ESC-NOW study, a multicenter, stepped-wedge cluster-randomized controlled trial (2020–2022) conducted at 26 US study hospitals. The 2016 American Community Survey was used to develop SDI scores based on the maternal zip code of residence at the time of delivery. Outcomes evaluated included receipt of pharmacologic treatment for NOWS (PT), receipt of breastmilk during hospital stay, direct breastfeeding at discharge, discharge disposition, and length of stay for infants who received PT (LOS).

Results:

The median SDI score was 62 on a scale of 100. The high SDI group, with a score above the SDI median and more social deprivation, was less likely to receive adequate prenatal care or medication for opioid use disorder and more likely to be Black and/or Hispanic. The mean proportion of infants in the high SDI group were 6.2 percentage points (RR 0.89, 95%CI 0.80,0.98) less likely to receive breastmilk during the newborn hospitalization and 7.3 percentage points (RR 0.91, 95%CI 0.87,0.96) less likely to be discharged home with a biological parent. There was no difference between the high and low SDI groups in receipt of PT, direct breastfeeding at discharge, or LOS.

Conclusion:

Mothers from high SDI communities with opioid exposure during pregnancy were less likely to receive the established standard of care and more likely to be Black and/or Hispanic. Infants born to these mothers were less likely to receive breastmilk and/or to be discharged home with a biological parent. Targeting interventions to mitigate the impact of social deprivation in high SDI communities may improve outcomes for opioid-exposed infants and their mothers.

Social DeprivationNeonatal Abstinence SyndromeOpioidPerinatal CareNeonatal Opioid Withdrawal SyndromeResidence CharacteristicsSociodemographic FactorsBackground:

The interplay between social factors and health outcomes is increasingly recognized as a critical part of quality health care. Beyond individual social factors, health outcomes may be impacted by the level of resources and/or social support in the area where one lives.1–3 The protective effect of community social support on health outcomes is particularly important for vulnerable populations including the mother-infant dyad affected by perinatal substance use.4,5

Perinatal opioid exposure affects mother-infant dyads of all socioeconomic statuses, though there are strong associations with poverty, Medicaid enrollment, and low educational attainment.6–10 Infants born to mothers who use opioids during pregnancy may experience neonatal opioid withdrawal syndrome (NOWS). On a county level, NOWS is more common in counties with designated mental health shortage areas, high unemployment rates, and higher infant foster care entry rates.11,12 Substance use, poverty, social deprivation, and stigma often coincide. Many mothers with substance use disorder during pregnancy report stigma as a significant barrier to care.13–22

The Eat, Sleep, Console (ESC) approach is a family-centered model of care increasingly used to care for infants with NOWS. When compared to usual care with the Finnegan tool, the ESC care approach has been shown to reduce the initiation of pharmacologic treatment and the length of hospital stay for these infants.23 The ESC care approach emphasizes parental engagement including non-pharmacologic care practices such as rooming in, breastfeeding, skin-to-skin care, and parental presence. Parent-focused interventions such as these may be more difficult for a parent who has limited social support, difficulties with transportation, tenuous employment, and/or unstable housing. Few studies have evaluated the relationship between social factors and the severity of NOWS during the infant hospitalization and findings from these studies vary.24,25 Further research is needed to elucidate the associations between social factors, including both social deprivation and support, and infant outcomes.

The Social Deprivation Index (SDI) is a composite area level measure of social deprivation that was developed with the goal of evaluating the relationship between area level disadvantage and health outcomes.26 The SDI is associated with a variety of health-related outcomes including cancer, infection, mental health, and other chronic health conditions.27–32 The relationship between SDI and medication for opioid use disorder (MOUD) and NOWS has not been assessed to date. This study aims to evaluate the association between maternal SDI at the time of delivery and maternal characteristics and infant outcomes for mother-infant dyads with perinatal opioid exposure.

Methods:Data Sources

This is a post hoc secondary analysis of mother-infant dyads enrolled in the Eat, Sleep, Console for Neonatal Opioid Withdrawal (ESC-NOW) stepped-wedge cluster-randomized controlled trial. This trial compared the Eat, Sleep, Console care approach to usual care with the Finnegan tool for infants who were at least 36 weeks’ gestation at birth, had evidence of antenatal opioid exposure, and were being assessed at a study hospital for NOWS severity. The study was conducted between September, 2020 and March, 2022 in 26 US hospitals across 18 states as a collaboration between the Environmental Influences on Child Health Outcomes (ECHO) Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN) and the Eunice Kennedy Shriver National Institute of Child Health and Human Developmenťs Neonatal Research Network (NRN). The primary analysis of ESC-NOW was published and the protocol may be found online.23

Participants

All ESC-NOW study participants for whom SDI scores could be calculated were included in this analysis. SDI scores were assigned as per the American Community Survey data using 5 year estimates (2012–2016) by zip code.26 The SDI is derived from 7 factors on the American Community Survey: percent of the population with household income less than 100% of the federal poverty level, percent of the population 25 years or more with less than 12 years of education, percent non-employed for population 16–64 years, percent households living in renter occupied housing units, percent households living in crowded housing units, percent single parent families with descendants <18 years, and percent households with no vehicle. SDI scores ranged from 1 (representing low social deprivation) to 100 (representing high social deprivation). This index was selected because it was developed to evaluate the relationship between area level disadvantage and health outcomes. Similar to other studies of SDI, the study cohort was divided into a low social deprivation group with an SDI score at or below the median for the cohort and a high social deprivation group with an SDI score above the median27,33.

Select components of the SDI were evaluated as independent variables: percent of the population with household income less than 100% of the federal poverty level, percent single parent families with descendants <18 years, and percent households with no vehicle. These components were selected due to their potential to negatively affect mothers’ ability to actively participate in the care of their infants. Correlations between the individual components were tested, and the associations between each component and the outcomes were evaluated.

Maternal characteristics and infant outcomes were compared between the low social deprivation group and the high social deprivation group. Maternal characteristics included: race/ethnicity, adequate prenatal care (defined as at least 3 visits with the first visit before the start of the third trimester), MOUD, polysubstance use, marital status, and type of insurance coverage.

Outcomes

Binary infant outcomes evaluated at hospital discharge included: receipt of pharmacologic treatment for NOWS, receipt of any maternal breastmilk during hospital stay, direct breastfeeding at discharge, and discharge home with a biological parent. Length of hospital stay (LOS) was a continuous infant outcome evaluated at hospital discharge in the subset of infants who received pharmacologic treatment - the subset of infants with NOWS who tend to have longer and more variable hospital duration.34

Statistical Analyses

Data were summarized as means and standard deviations for continuous variables and counts with percentages for categorical variables. A significance threshold of 2-sided P < 0.05 was used for all analyses without correction for multiple comparisons. All regression models accounted for the stepped-wedge design, with intervention and period as fixed effects and site-specific random intercepts, along with the strata indicator (proportion of infants treated pharmacologically at each site prior to trial initiation according to lowest third, middle third, and highest third). Additional analyses were conducted with further adjustments for key baseline maternal and infant characteristics, including maternal race/ethnicity, MOUD, adequate prenatal care (at least 3 visits with the first visit before the start of the third trimester) and polysubstance exposure. The effects of the NOWS care approach on outcomes across social deprivation group categories were assessed through analysis of the interaction between the intervention and SDI group category.

For binary outcomes, mixed-effect Poisson regression with robust error variance were used and reported as relative risk with 95% confidence intervals. For LOS in pharmacologically treated infants, generalized linear mixed models with negative binomial distribution and log-link was used, reporting incidence rate ratio. All analyses were conducted using SAS version 9.4 (SAS Institute Inc.) and Stata/BE version 18.0 (StataCorp).

Results:

Of the 1305 mother-infant dyads enrolled in the primary study, 1298 (99%) were included in this secondary analysis. Seven were excluded due to missing SDI scores. The median SDI score for the study cohort was 62 on a scale from 1 (low social deprivation) to 100 (high social deprivation), which reflected more social deprivation in our study population than the general United States population (median of 37 for all zip codes).26 Using the median SDI of 62, the study cohort was divided into a low social deprivation group (SDI score ≤62, n=657) and a high social deprivation group (SDI score > 62, n=641, Figure 1).

Maternal Characteristics:

Women in the high social deprivation group were less likely to receive adequate prenatal care (60% vs 68%) or MOUD (73% vs 78%) when compared to the low SDI group. Mothers in the high SDI group were more likely to be Black (21% vs 6%) or Hispanic (13% vs 9%) (Table 1). Non-Hispanic Black mothers represented 13% of the total study population, 79% of them were in the high SDI group. Similarly, Hispanic mothers represented 11% of the study population with 60% of them in the high SDI group. The high SDI group was also more likely to be single (89% vs 80%) and enrolled in public insurance (93% vs 84%) compared to the low SDI group. There was no substantial difference in polysubstance exposure between SDI groups. Differences in race/ethnicity, adequate prenatal care, MOUD, and polysubstance exposure were accounted for in the adjusted models for infant outcomes.

Infant Outcomes:

For all outcomes, the effects of the NOWS care approach (ESC vs usual care) between the SDI groups (high vs low social deprivation) were examined by analyzing the interaction between the intervention and SDI group. These interactions were not statistically significant. Therefore, models excluded the interaction items and reported the estimated effects on SDI groups.

In the high SDI group, the proportion of infants who received any maternal breastmilk during the hospital stay was 6.2 percentage points (95%CI: 0.8%,11.5%) less than in the low SDI group (47.7% vs 53.9%; RR 0.89 (95%CI: 0.80,0.98); P=0.023) (Table 2). The proportion of infants in the high SDI group discharged home with a biological parent was 7.3 percentage points (95%CI: 3.1%,11.5%) less than those in the low SDI group (76.9% vs 84.2%; RR 0.91 (95%CI: 0.87,0.96); P=0.001). There was no difference in receipt of pharmacologic treatment for NOWS (RR 1.16, 95%CI: 0.99,1.38), LOS for pharmacologically treated infants (IRR 0.96, 95%CI: 0.88,1.05), or direct breastfeeding at discharge (RR 0.87, 95%CI: 0.74,1.02) between groups.

Select SDI components that may impact the ability of mothers to be present in the hospital were evaluated as independent variables (Table 3). The proportion of infants discharged home with a biological parent was 5.9 percentage points (95%CI: 2.1%,9.7%) less if mothers lived in regions where more than the median proportion of the population had a household income less than 100% of the federal poverty level (77.7% vs 83.5%; RR 0.93 (95%CI: 0.89,0.98); P=.003); 7.1 percentage points (95%CI: 3.4%,10.8%) less if mothers lived in regions where more than the median population had single parent families with descendants <18 years (77.1% vs 84.2%; RR 0.92 (95%CI: 0.87,0.96); P<.001); and 7.5 percentage points (95%CI: 3.6%,11.3%) less if mothers lived in regions where more than the median proportion of households had no vehicle (76.8% vs 84.3%; RR 0.91 (95%CI: 0.87,0.96); P<.001). The proportion of infants who received any maternal breastmilk during the newborn hospital stay was 6.8 percentage points (95%CI: 2.4%,11.3%) less if their mothers lived in regions where more than the median proportion of households had no vehicle (47.5% vs 54.3%; RR 0.87 (95%CI: 0.80,0.95); P=.002). There was no substantial difference in the proportion of infants who received any maternal breastmilk during the newborn hospital stay between groups based on regional poverty level or single parent families.

Discussion:

In this secondary analysis of infants enrolled in the ESC-NOW randomized controlled trial and their mothers, there were notable differences in maternal characteristics and infant outcomes between low and high SDI groups based on the SDI of the mother’s area of residence. Deviation from the standard of care during pregnancy for women with opioid exposure, which includes regular prenatal care and engagement with MOUD, was more common in the high SDI group. Women in this group were less likely to receive adequate prenatal care and MOUD during pregnancy. In addition, women in the high SDI group were more likely to be Black and/or Hispanic. When controlling for these baseline differences in maternal characteristics, a smaller proportion of infants in the high SDI group received maternal breastmilk during the newborn hospital stay and/or were discharged home with a biologic parent when compared to the low SDI group.

The differences in maternal characteristics and infant outcomes noted in this study mirror known associations. Numerous studies highlight the negative effect of social barriers on access to MOUD or type of MOUD35–37 and lower socioeconomic status is a predictor of inadequate prenatal care.38 Black and Hispanic populations are more likely to live below the poverty level and are more often tested for substance use than white families.39–45 Families living in poverty, in particular Black families, are also more likely to have child welfare involvement.41,46 These factors may have contributed to the lower-proportion of infants discharged home with a biological parent in the high SDI group. Both indices of neighborhood disadvantage and race/ethnicity are associated with differences in any breastmilk exposure and continued exclusive breastmilk feeding rates.47 Our findings align with this published literature and contribute a novel association between the SDI score and characteristics and outcomes for mother-infant dyads affected by perinatal opioid exposure.

Our study did not find an association between SDI and receipt of pharmacologic treatment for NOWS or LOS in pharmacologically treated infants. This differs from existing literature showing higher levels of poverty in a mother’s community, as represented by the Area Deprivation Index, to be associated with excess length of stay for infants with NOWS24 and maternal food insecurity to be associated with receipt of pharmacologic treatment for infants with NOWS.25 These were comparatively small studies performed at single centers utilizing varied metrics of social deprivation. Further study is needed to better understand the association between metrics of social deprivation and receipt of pharmacologic treatment or LOS for infants with NOWS.

Gaining insight into the complex relationship between social factors and health outcomes is an important first step in designing and testing interventions related to social supports to improve health outcomes.48,49 Identifying that high SDI mothers are at increased risk of not receiving adequate prenatal care and/or MOUD and their infants are at an increased risk of not receiving breastmilk and discharging home with a non-biological caregiver provide valuable future intervention targets.

Potential targeted strategies to support mothers and families in areas of high social deprivation include programs that provide culturally-sensitive, trauma-informed, relationship-based, patient- and family-focused care in a supportive multi-disciplinary and integrated manner, and do so in high risk communities.50 Such programs aim to reduce the effects of compounded stigma and bias related to social deprivation and perinatal substance use as well as implicit bias in system policies and barriers to accessing quality resources. In recent years, there has been an increase in the development of integrated and/or co-located perinatal substance use disorder programs that bring together obstetric care with treatment of substance use disorders and co-occurring mental health conditions as well as care coordination for health-related social needs. Such programs have the potential to reduce barriers to recommended prenatal and substance use care by providing a centralized trauma-informed, stigma-free care environment with care coordination to reduce barriers such as time and transportation limitations to attending appointments at multiple sites. Integrated care models are associated with improved obstetric outcomes and lower rates of positive maternal toxicology testing at the time of delivery.51–53 Similarly, co-locating pediatric care with the mother’s treatment program and/or developing specialty pediatric medical homes for families with perinatal opioid exposure offers an opportunity to provide coordinated trauma-informed care that supports and strengthens parenting and connects families to needed community resources, both of which can potentially mitigate the need for child welfare involvement.54 Thoughtful placement of such programs in high SDI locations and consideration for ways to increase access to transportation, telehealth, and other virtual supports (e.g., parenting, lactation, and substance use peer support) are additional interventions that should be considered.

There are a number of parenting interventions which focus on quality of parent-child relationship, emotional regulation and caregiver responsiveness that may promote family well-being and mitigate increased risks related to high SDI. These interventions include: BRIGHT (Building Resilience through Intervention: Growing Healthier Together), Mothering from the Inside Out, and Circle of Security among others.55–58 These approaches align well with the trauma-informed and family-centered model of ESC and may provide mothers with ongoing support in a continuum of care. Early identification of families in prenatal and substance use treatments living in areas with high SDI may offer an opportunity for care systems to connect families with parenting resources and education that enable families to stay together or support reunification. Use of formal interdisciplinary-developed “Plans of Safe Care” to support families may be an effective tool for this coordinated education and support.52,59,60

Finally, integration of peer counselors into breastfeeding education and lactation support in high SDI communities may help to improve breastfeeding rates.61–65 In addition to reducing barriers for lactation support, ensuring hospital policies reflect the current standard of care for lactation support in the setting of substance exposure may help address barriers to breastfeeding.66

While the large sample size and prospectively collected data from this multicenter cohort are clear strengths of this study, there are several limitations. 1) a regional measure of social deprivation may speak to community level resources in a way that individual metrics do not, yet it could also over- or under-estimate an individual’s social deprivation,67 2) as a post hoc secondary analysis, this analysis was limited to the data collected for the primary study and did not include detailed individual information about social deprivation, and 3) the SDI is a composite measure that combines information about different types of social deprivation into one score; it is possible that additional component level information could identify aspects of social deprivation that impact particular outcomes more than others and that updates in SDI may have occurred between 2012–2016 and our study period 2020–2022.

In combination, our study findings highlight the need to further investigate social factors in order to improve care for opioid-exposed dyads. While ongoing support is critical for all families impacted by opioid exposure, this study suggests that those residing in areas with high SDI are particularly vulnerable and consideration should be paid to this when planning for program implementation. When developed, such programs deserve further study to ensure they are reaching families at high risk and improving access to care.

Conclusion:

Mother-infant dyads in the ESC-NOW trial who resided in communities with higher levels of social deprivation differed in maternal characteristics and infant outcomes from those who resided in communities with less social deprivation. Mothers in these more vulnerable communities were less likely to receive established standards of care and more often Black and/or Hispanic, while their infants had comparatively poorer outcomes. Targeting interventions to mitigate the impact of social deprivation may help to improve pregnancy and neonatal outcomes in this population.

Acknowledgements

We extend our deepest gratitude to the infants and caregivers/parents who participated in this study, without whom, the study and resulting implications for the medical community would not have been possible.

The National Institutes of Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Center for Advancing Translational Sciences (NCATS) provided support for the Neonatal Research Network (NRN) and the National Institutes of Health, Office of the Director, Environmental influences on Child Health Outcomes (ECHO) program provided support for the Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN). While NICHD and NIH ECHO staff had input into the study design, conduct, analysis, and manuscript drafting, the comments and views of the authors do not necessarily represent the views of NICHD, the NIH ECHO staff, the National Institutes of Health, the Department of Health and Human Services, or the U.S. Government.

We acknowledge the co-creators of the ESC Care Tool: Boston Medical Center, Yale and CHaD.

We also acknowledge the contribution and dedication of ESC Training Team: DeAnn Hubberd, MA, CCRP, and Kathy Edwards, BSN, RN, CCRP, CCRA Associate Directors/Project Leads ECHO ISPCTN Data Coordinating & Operations Center (DCOC) and the ESC Faculty: Bonny L. Whalen, MD, Dartmouth Hitchcock Medical Center, Kate MacMillan, MD, MPH, Mass General for Children: Pediatric Hospital Medicine, Adrienne Pahl, M.D., Department of Pediatrics, University of Vermont Larner College of Medicine, Farrah Sheehan Deselle, MSN, RN, IBCLC, CCBE(BFW), Katie White, RN.

We are indebted to our medical and nursing colleagues and the ESC faculty who agreed to take part in this study. The following investigators, in addition to those listed as authors, participated in this study:

Case Western Reserve University, Rainbow Babies & Children's Hospital (UG1 HD21364) – Moira Crowley, MD; Anna Maria Hibbs, MD, MSCE, FAAP; Leslie Clarke, RN, MS, MBA; Kathy Serio, RNC-LRN, BSN; Maria Kertesz, RN, MSN; Ashley Rodriguez, MSN, APRN, NNP- BC; Sarah Driscoll, RNC-LRN, BSN; Kim Hammond, RNC-LRN, BSN; Deborah Hines, RN, BSN; Patricia Kish, RN, BS; Taylor Schmidt, RN, BSN; Jennifer Stepp, RN, BSN.

Children’s Mercy Hospital and Advent Health – Shawnee Mission – Julie Weiner, MD; Jodi Jackson, MD; Allie Scott, RN, CCRC; Rochelle Brown, RN, MSN; Kari Smith, RN, RNC-OB, C-EFM, MSN; Roxanne Kerry, RN, BSN; My Rieper, RN, CPN, MSN; Carrie Miner, RN; Lynne Ray.

Christiana Care Health Systems (UG1 OD024958) – David Paul, MD; Karen Kowel, PAC; Victoria Reynolds, BA; Diana Castellone, BA, Amy Mackley.

Cincinnati Children's Hospital Medical Center, University Hospital, St. Elizabeth and Good Samaritan Hospital (UG1 HD27853, UL1 TR77) – Ward Rice, MD, PhD; Jennifer M. McAllister, MD; Kurt Schibler, MD; Traci Beiersdorfer, RN, BSN; Cathy Grisby, RN, BSN, CCRC; Kristin Kirker, CRC; Katherine McKeown, RNC-NIC, BSN; M. Katherine Loudermilk, MD; Amy Carnohan, RN, MSN; Patti Froese, NNP-BC, DNP; April Haddix, RN; Virginia Summe, RN; Clara Chlon, MD; Rita Kunk, CNP; Jen Hamilton, RN, VA-BC, BSN; Sadie Moore; Angela Ziegelmeyer RN, BSN; Lucy Rolfes, RN, BSN; Erica Schomaker, CLC, BSN; Holly Strike, MD; Sharon Harvey, RNC-NIC, BSN; Paula Richards, RNC-OB, C-EFM, MSN; Ashley Simon, RNC-NIC, MSN; David Russell, JD.

Data and Safety Monitoring Committee – Christine A. Gleason, MD, University of Washington; Marilee C. Allen, MD, Johns Hopkins University School of Medicine; Robert J. Boyle, MD, University of Virginia Health System; Traci Clemons, PhD, The EMMES Corporation; Mary E. D’Alton, MD, Columbia Ob/Gyn Midtown; Robin Steinhorn, MD, University of California San Diego; Steven J. Weiner, MS, The George Washington University.

Duke Clinical Research Center (3U2COD023375–06S1, 3U2COD023375–07S2) - Michelle Schreiner, MSN; Ann Holmes, CCRA; Theresa O’Reilly, BA; Candice Quick, BA; Shani Alston, BA.

Duke University School of Medicine (UG1 HD40492, UL1 TR1117) – Sophie K Shaikh, MD, MPH; C. Michael Cotten, MD, MHS; Joanne Finkle, RN, JD; Kimberley A. Fisher, FNP-BC, IBCLC, PhD; Kathryn E. Gustafson, PhD; Chantal Watkins, RN, CCRN, BSN; Rachel Demerath, RN, CPN, BSN; Margaret Oakes RNC-MNN, CLRN, BSN; Linda Wallace, RN; Lisa Hill, RN.

Emory University School of Medicine, Department of Pediatrics, Children’s Healthcare of Atlanta – Brenda Poindexter, MD

Environmental Influence on Child Health Outcomes (ECHO) – Alan Simon, MD; Carol J. Balisdell, MD.

Eunice Kennedy Shriver National Institute of Child Health and Human Development – Andrew Bremer, MD; Rosemary D. Higgins, MD; Michele C. Walsh, MD; Stephanie Wilson Archer, MA.

Kapiolani Hospital (UG1 OD024948) - Annette Amiotte, BSN; Moara Santos, PhD; Jill Taosaka, OTR; Charles Neal, MD.

MUSC Health Shawn Jenkins Children’s Hospital (UG1 OD024956) – Julie Ross, MD; Andrew M. Atz, MD; Andrea Summer, MD, MSCR; Michelle Amaya, MD, MPH; Mary Freeman, CCRP; Madison Johnson, CCRP; Layla Al Sarraf, CCRP; Rosemary Ros-Demarize, PhD.

Nationwide Children’s Hospital, The Abigail Wexner Research Institute at Nationwide Children’s Hospital, Center for Perinatal Research, The Ohio State University College of Medicine (UG1 HD68278) – Erica F. Braswell, MD; Pablo J. Sánchez, MD; Jonathan L. Slaughter, MD, MPH; Patricia Luzader, RN; Laura Marzec, IMG; Brittany DeSantis, BS; Kristi Small, BS; Julia Newton, MPH; Jessica Purnell, CCRC, BS; Rachel Reedy, RN; Cory Hanlon, BS; Tanvi Naik, BS; Jordan Knox, BS; Aishwarya Tallikar, BS; Chelsea Cobe, BA; Megan Resetar, RN; Jacqueline McCool; Erin Frailey, RN; Stephanie Jones, RN; Stacy Williams, RN; Taise Staton, RN; Jacqueline N. Palmer, PA-C; Jana L. Erner, MD; Jason B. Kovalcik, MD; Erin L. Keels, DNP, APRN-CNP, NNP-BC; Teri McCarty, PharmD.

Norton Children’s Hospital (UG1 OD024954) – Sucheta Telang, MD; Katherine Harris, CCRC, MA, MPH; Meagan DeSpain, CCLS, MS; Jackie Boyd RN, BSN, CHPE, CCRC; Sara Watson, MD, MS; Jan Sullivan, MD.

Oklahoma University Health Sciences Center (UG1 OD024950) – Devon W. Hahn; Timothy Walsh, MPH; Brianna Anderson; Devon Hahn, MD; Christi Madden, MPA; Anne Nascimbeni, RN; Shannon Wilson, RN; Theresa Gibson, RN; John Karlin, RN

RTI International (UG1 HD36790) – Carla M. Bann, PhD; Jeanette O’Donnell Auman, BS; Eugene Turner, BS; Emily Smith, MPH; Lauren Bradley, MPH; Jenna Gabrio, MPH; David Leblond, BS; James Pickett, BS; Jamie E. Newman, PhD, MPH; Kristin M. Zaterka-Baxter, RN, BSN, CCRP.

Sanford Health (UG1 HD53109, UL1 TR442) – Jessica R. White, MD; Stephen Messier, MD; Michelle L. Baack, MD; Laurie A. Hogden, MD; Allison Lutz; Megan M. Henning, RN; Sarah Van Muyden, RN, BSN; AnaLisa Martino, MD; Stephen Messier, MD; Allison Lutz, RN; Jeralyn Nelson, RN; Bette Schumacher, CNS; Aimee Brodkorb, RNC, BSN; Deborah Pritchett, PharmD.

Spartanburg Regional Medical Center (UG1 OD024956) – Jaime Brown, MD; Kristen Ford, BSN, MSN; Darla Howard, RN; Ryan Orland, MD.

Tulane Lakeside Hospital, Tulane University School of Medicine (UG1 OD024959) – Meghan Howell, MD; Monique Diles, RN, BSN.

University of Arkansas for Medical Sciences (U24 OD024957) – Zhuopei Hu, MS; Jeannette Lee, PhD; Jessica N. Snowden, MD; Kay L. Shuttleworth, PhD; DeAnn E. Hubberd, CCRP, MA; Kathy D. Edwards, RN, CCRP, CCRA, BSN; Sherry L. Lloyd, BA; Catrice Banks-Johnson, BBA, MPA; Patrina Robinson, BA; Melissa Griffith, RHIT.

University of Kansas Medical Center (UG1 OD024943) – Krishna Dummula, MD, MPH; Amie Slaughter, NP; Teresa Kilkenny, NP; Kristina Foster, RN, MS, APRN-BC, CCRP; Morgan Cross, RN, BSN; Jessica Gier, RN, BSN; Natalie Roberts, RN, BSN; Jessica Wadman, RN; Kathy Cathey, RN; Jenna Todd, RN.

University of Mississippi Medical Center (UG1 OD024942) – Lauren Tucker, MD; Emily Fratesi, RNC; Lacy Malloch, BS; Radha Alur, MD; Joseph Marc Majure, MD; Courtney Walker, PhD; Catherine Powers, MEd; Robert D. Annett, PhD

University of Nebraska Medical Center (UG1 OD024953) – Sarah Newman, APRN, DNP; Rachel Wellman, RN; Kerry Miller, MD; Ann Anderson-Berry, MD, PhD

University of New Mexico Health Sciences Center (2UG10D024947–03; U10 HD053089) – Jessie R. Maxwell, MD; Hengameh Raissy, PharmD; Alberta Kong, MD, MPH; Kate McCalmont, MD; Sandra Sundquist Beauman, RNC, MSN; Sarah Sanders, RN, BSN, MSESS.

University of Pennsylvania, Hospital of the University of Pennsylvania, Pennsylvania Hospital, and Children's Hospital of Philadelphia (UG1 HD68244) – Karen M. Puopolo, MD, PhD; Lori Christ, MD; Eric C. Eichenwald, MD; Toni Mancini, RN, BSN, CCRC; Kristina Ziolkowski; Megan Dhawan CRNP, BSN, MSN; Mary Kay Gambacorta, RN; Allie Pulsifer, CRNP-PNP, MSN; Marisa Brant, MD; Aida Schumacher, RN, CNL, MSN; Sydney Gocial, RN; Kristen Azuma, RN; Elizabeth Quigley, RN, MSN; Whitney Zachritz RN, CPNP-PC, MSN; Nicole Pastore, RN; Jessica Barber, CRNP, MSN; Abby McDowell, CRNP; Alissa Ferri, RN, BSN; Joanna Parga-Belinkie, MD.

University of Rochester Medical Center, Golisano Children's Hospital, and the University of Buffalo Women's and Children's Hospital of Buffalo (UG1 HD68263, UL1 TR42) – Anne Marie Reynolds, MD, MPH; Julie Riccio, MD; Ronnie Guillet, MD, PhD; Rosemary L. Jensen; Alison Kent, MD, FRACP, BMBS; Ann Marie Scorsone, CCRC, MS; Satyan Lakshminrusimha, MD; Michelle E. Hartley-McAndrews, MD; Emily Li, BA; Jennifer Donato, BS; Kimberly G. McKee, BS; Carl D’Angio, MD; Rachel Jones; Dacia Terrano, RN; Stephanie Solpietro, PNP; Lisa Brei, RN; Lisa Krokovich, RN; Sema Hart, MD; John Pastore, MD; Ashley Kern, RN, Margaret Mars, RN; Patricia Volker, RN, MSN; Annette Mioneo Brady, RN, MSN; Kelsey Voelker, BS; Emily Horn, MS; Melissa Moreland, MPH.

University of South Florida – Tanner Wright, MD; Marcia Kneusel, RNC, CCRC; Maya Balakrishnan, MD; Jillian Childres, PhD; Melissa Hanniman, RN, BSN; Rebecca White, RN.

University of Utah Medical Center (UG1 HD87226, UL1 TR105) – Camille M. Fung, MD; Robin K. Ohls, MD; Mariana Baserga, MD, MSCI; Bhanu Muniyappa, MD; Julie Shakib, DO, MS, MPH; Carrie A. Rau, RN, CCRC, BSN; Shawna Baker, RN; Kathie Coleman, RN; Kandace M. McGrath, BS; Brandy Petersen, RN; Jael Waldvogel, RN; Monika Bracken, RN; Meredith Ferrin, RN; Holly DeSantis, RN; Traci Perkins, RN; Manndi C. Loertscher, BS CCRP.

Winchester Hospital - Karen McAlmon, MD, FAAP; Justin Goldstein, MD, FAAP; Asimenia Angelidou, MD, FAAP; Nancy Donahue.

Conflict of Interest Disclosures: Rachel G. Greenberg has received support from industry for research services (https://dcri.org/about-us/conflict-of-interest/). No other disclosures were reported.

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Analytic sample based on ESC-NOW study cohort

Characteristics of mothers and infants by dichotomized SDI score (SDI score ≤ Median a vs SDI score > Median)

Low:SDI score ≤ Median(N = 657)High:SDI score > Median(N = 641)
Treatment Arms - no./total no. (%)
 Usual Care342/657 (52)353/641 (55)
 Eat, Sleep, Console315/657 (48)288/641 (45)
Maternal Characteristics - no./total no. (%)
Race/Ethnicity b,c
 Non-Hispanic white523/642 (81)381/631 (60)
 Non-Hispanic Black36/642 (6)133/631 (21)
 Hispanic56/642 (9)83/631 (13)
 Other d27/642 (4)34/631 (5)
 Missing1510
Adequate Prenatal Care c,e
 Yes430/637 (68)378/631 (60)
 No207/637 (32)253/631 (40)
 Missing2010
Medication for Opioid Use Disorder c
 Yes500/639 (78)458/624 (73)
 No139/639 (22)166/624 (27)
 Missing1817
Polysubstance Exposure f
 Yes372/657 (57)386/641 (60)
 No285/657 (43)255/641 (40)
Marital Status c
 Married126 (20)71/629 (11)
 Single512 (80)558/629 (89)
 Missing1912
Insurance g
 Public Insurance c549/657 (84)598/641 (93)
 Private Insurance c85/657 (13)29/641 (5)
 Self-pay/uninsured13/657 (2)16/641 (2)
 Unknown Insurance19/657 (3)10/641 (2)

Median Social Deprivation Index (SDI) score for the study cohort is 62 out of 100. The high SDI group has more community social deprivation (a score above the SDI median). The low SDI group has less community social deprivation (a score at or below the SDI median).

Race and ethnicity were obtained from the electronic medical record.

Chi-square test, p<0.05

Other: American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, Asian, and more than one race.

Adequate prenatal care: ≥ 3 visits and prenatal care prior to the initiation of the third trimester.

Polysubstance exposure: exposure to opioids in addition to any of the following: amphetamines, barbiturates, benzodiazepines, kratom, cocaine, gabapentin, marijuana, methamphetamines, phencyclidine, and selective serotonin reuptake inhibitors.

Insurance categories are not mutually exclusive.

Outcome measures by dichotomized SDI score (SDI score ≤ Median a vs SDI score > Median)

OutcomesModels bAdjusted by study designModels cAdjusted by study design and characteristics
Estimated MeansEstimated MeansAbsolute Difference(95% CI)Estimated Effect(95% CI)
Low:SDI score≤ MedianHigh:SDI score> MedianLow:SDI score≤ MedianHigh:SDI score> Median
Percent of receipt of pharmacologic therapy (N = 1298)32.9(26.6, 39.3)36.0(30.1, 41.9)32.0(26.1, 37.8)37.2(32.4, 42.0)5.3(−0.3, 10.8)1.16 d(0.99, 1.38)
Percent of breastmilk feeding during hospital stay (N = 1298)53.9(49.1, 58.6)45.5(42.1, 48.9)53.9(49.2, 58.6)47.7(43.9, 51.6)6.2(0.8, 11.5)0.89 d(0.80, 0.98)
Percent of receipt of direct breastfeeding at discharge (N = 1298)28.7(23.6, 33.7)22.9(18.0, 27.8)27.3(23.1, 31.6)23.7(18.6, 28.7)3.7(−0.2, 7.5)0.87 d(0.74, 1.02)
Percent of discharge with parents (N = 1285)83.2(80.4, 86.0)76.3(72.4, 80.3)84.2(81.9, 86.6)76.9(73.5, 80.3)7.3(3.1, 11.5)0.91 d(0.87, 0.96)
Length of stay (day) for infants who received pharmacologic treatment (N = 458)20.4(18.3, 22.5)19.8(17.8, 21.8)20.9(18.7, 23.2)20.2(18.1, 22.3)0.7(−1.1, 2.6)0.96 e(0.88, 1.05)

Median Social Deprivation Index (SDI) score for the study cohort is 62 out of 100. The high SDI group has more community social deprivation (a score above the SDI median). The low SDI group has less community social deprivation (a score at or below the SDI median).

Adjusted for the trial design – with intervention (usual care vs. ESC) and period as fixed effect, and a site-specific random intercept to account for the clustering of infants within sites, and a randomization strata indicator.

Adjusted for the trial design (listed above) and baseline characteristics including maternal ethnicity/race, medication for opioid use disorder, adequate prenatal care and poly exposure.

Reported as relative risk (RR) based on mixed effect Poisson regression model with robust error variance.

Reported as incidence rate ratio (IRR) based on a generalized linear mixed model (GLMM) with negative binomial distribution.

Outcome measures for select area level SDI components dichotomized (component percent ≤ Median vs component percent > Median)

OutcomesModels aAdjusted by study designModels bAdjusted by study design and characteristics
Estimated MeansEstimated MeansAbsolute Difference(95% CI)Estimated Effect(95% CI)
Low:component %≤ MedianHigh:component %> MedianLow:component % ≤ MedianHigh:component %> Median
Percent of the population with household income less than 100% of the federal poverty level
Percent of receipt of pharmacologic therapy (N = 1298)33.4(27.0, 39.8)35.4(29.3, 41.5)32.5(26.7, 38.3)36.6(31.3, 41.8)4.1(−2.1, 10.2)1.13 c(0.94, 1.35)
Percent of breastmilk feeding during hospital stay (N = 1298)52.7(47.5, 58.0)46.7(43.0, 50.5)53.0(48.1, 57.9)48.7(45.1, 52.3)4.3(−0.9, 9.5)0.92 c(0.83, 1.02)
Percent of receipt of direct breastfeeding at discharge (N = 1298)27.9(23.2, 32.6)23.7(18.5, 28.9)26.7(22.6, 30.7)24.5(19.3, 29.6)2.2(−1.5, 5.9)0.92 c(0.79, 1.07)
Percent of discharge with parents (N = 1285)82.8(79.9, 85.7)76.7(73.1, 80.4)83.5(81.3, 85.8)77.7(74.4, 80.9)5.9(2.1, 9.7)0.93 c(0.89, 0.98)
Length of stay (day) for infants who received pharmacologic treatment (N = 458)20.6(18.4, 22.7)19.7(17.7, 21.7)21.0(18.8, 23.3)20.1(18.0, 22.2)0.9(−0.9, 2.8)0.96 d(0.87, 1.05)
Percent of the population single parent families with descendants <18 years
Percent of receipt of pharmacologic therapy (N = 1298)34.3(28.7, 40.0)34.5(28.7, 40.4)33.8(28.2, 39.4)35.3(30.6, 40.1)1.5(−3.4, 6.4)1.05 c(0.91, 1.21)
Percent of breastmilk feeding during hospital stay (N = 1298)53.5(48.8, 58.2)46.1(42.0, 50.1)53.9(49.2, 58.6)48.0(43.7, 52.3)5.9(0.0, 11.8)0.89 c(0.79, 1.00)
Percent of receipt of direct breastfeeding at discharge (N = 1298)27.7(23.0, 32.3)23.9(18.4, 29.4)26.2(21.5, 30.8)25.1(20.0, 30.3)1.0(−3.9, 6.0)0.96 c(0.79, 1.17)
Percent of discharge with parents (N = 1285)83.4(81.1, 85.8)76.2(72.8, 79.6)84.2(81.9, 86.6)77.1(74.1, 80.1)7.1(3.4, 10.8)0.92 c(0.87, 0.96)
Length of stay (day) for infants who received pharmacologic treatment (N = 458)20.3(18.2, 22.4)19.9(17.8, 21.9)20.9(18.6, 23.2)20.2(18.1, 22.4)0.7(−1.2, 2.5)0.97 d(0.88, 1.06)
Percent of households with no vehicle
Percent of receipt of pharmacologic therapy (N = 1298)32.2(25.3, 39.1)36.5(31.4, 41.6)31.5(24.9, 38.1)37.5(33.5, 41.5)6.0(0.4, 11.6)1.19 c(1.00, 1.42)
Percent of breastmilk feeding during hospital stay (N = 1298)53.5(49.5, 57.4)46.1(42.7, 49.4)54.3(50.1, 58.5)47.5(43.7, 51.2)6.8(2.4, 11.3)0.87 c(0.80, 0.95)
Percent of receipt of direct breastfeeding at discharge (N = 1298)28.3(23.2, 33.4)23.7(18.5, 28.9)27.3(22.8, 31.8)24.0(18.9, 29.1)3.3(−0.9, 7.5)0.88 c(0.74, 1.04)
Percent of discharge with parents (N = 1285)82.9(79.9, 85.8)76.7(73.5, 79.8)84.3(81.5, 87.2)76.8(74.2, 79.5)7.5(3.6, 11.3)0.91 c(0.87, 0.96)
Length of stay (day) for infants who received pharmacologic treatment (N = 458)20.5(18.3, 22.7)19.9(17.9, 21.9)20.9(18.5, 23.2)20.3(18.2, 22.4)0.6(−1.3, 2.5)0.97 d(0.89, 1.07)

Adjusted for the trial design – with intervention (usual care vs. ESC) and period as fixed effect, and a site-specific random intercept to account for the clustering of infants within sites, and a randomization strata indicator.

Adjusted for the trial design (listed above) and baseline characteristics including maternal ethnicity/race, medication for opioid use disorder, adequate prenatal care and poly exposure.

Reported as relative risk (RR) based on mixed effect Poisson regression model with robust error variance.

Reported as incidence rate ratio (IRR) based on a generalized linear mixed model (GLMM) with negative binomial distribution.

Key Points:

Living in an area with high social deprivation was associated with differences in health outcomes

Mothers were more likely to be Black and/or Hispanic

Mothers were less likely to receive the standard of care during pregnancy

Infants were less likely to receive breastmilk and/or be discharged home with a biological parent

Interventions designed to address community social deprivation may improve outcomes