Efficacy of a Vibrating Crib Mattress to Reduce Pharmacologic Treatment in Opioid-Exposed Newborns: A Randomized Clinical Trial.

Importance: Pharmacologic agents are often used to treat newborns with prenatal opioid exposure (POE) despite known adverse effects on neurodevelopment. Alternative nonpharmacological interventions are needed. Objective: To examine efficacy of a vibrating crib mattress for treating newborns with POE. Design, Setting, and Participants: In this dual-site randomized clinical trial, 208 term newborns with POE, enrolled from March 9, 2017, to March 10, 2020, were studied at their bedside throughout hospitalization. Interventions: Half the cohort received treatment as usual (TAU) and half received standard care plus low-level stochastic (random) vibrotactile stimulation (SVS) using a uniquely constructed crib mattress with a 3-hour on-off cycle. Study initiated in the newborn unit where newborns were randomized to TAU or SVS within 48 hours of birth. All infants whose symptoms met clinical criteria for pharmacologic treatment received morphine in the neonatal intensive care unit per standard care. Main Outcomes and Measures: The a priori primary outcomes analyzed were pharmacotherapy (administration of morphine treatment [AMT], first-line medication at both study sites [number of infants treated], and cumulative morphine dose) and hospital length of stay. Intention-to-treat analysis was conducted. Results: Analyses were performed on 181 newborns who completed hospitalization at the study sites (mean [SD] gestational age, 39.0 [1.2] weeks; mean [SD] birth weight, 3076 (489) g; 100 [55.2%] were female). Of the 181 analyzed infants, 121 (66.9%) were discharged without medication and 60 (33.1%) were transferred to the NICU for morphine treatment (31 [51.7%] TAU and 29 [48.3%] SVS). Treatment rate was not significantly different in the 2 groups: 35.6% (31 of 87 infants who received TAU) and 30.9% (29 of 94 infants who received SVS) (P = .60). Adjusting for site, sex, birth weight, opioid exposure, and feed type, infant duration on the vibrating mattress in the newborn unit was associated with reduction in AMT (adjusted odds ratio, 0.88 hours per day; 95% CI, 0.81-0.93 hours per day). This translated to a 50% relative reduction in AMT for infants who received SVS on average 6 hours per day. Among 32 infants transferred to the neonatal intensive care unit for morphine treatment who completed treatment within 3 weeks, those assigned to SVS finished treatment nearly twice as fast (hazard ratio, 1.96; 95% CI, 1.01-3.81), resulting in 3.18 fewer treatment days (95% CI, -0.47 to -0.04 days) and receiving a mean 1.76 mg/kg less morphine (95% CI, -3.02 to -0.50 mg/kg) than the TAU cohort. No effects of condition were observed among infants treated for more than 3 weeks (n = 28). Conclusions and Relevance: The findings of this clinical trial suggest that SVS may serve as a complementary nonpharmacologic intervention for newborns with POE. Reducing pharmacotherapy with SVS has implications for reduced hospitalization stays and costs, and possibly improved infant outcomes given the known adverse effects of morphine on neurodevelopment. Trial Registration: ClinicalTrials.gov Identifier: NCT02801331.

Effect of antenatal milk expression education on lactation outcomes in birthing people with pre-pregnancy body mass index ≥25: protocol for a randomized, controlled trial.

BACKGROUND: Birthing people with pre-pregnancy body mass indices (BMIs) ≥ 25 kg/m2, particularly those without prior breastfeeding experience, are at increased risk for suboptimal lactation outcomes. Antenatal milk expression (AME) may be one way to counteract the negative effects of early infant formula supplementation common in this population. METHODS: This ongoing, randomized controlled trial in the United States evaluates the efficacy of a telelactation-delivered AME education intervention versus an attention control condition on lactation outcomes to 1 year postpartum among 280 nulliparous-to-primiparous, non-diabetic birthing people with pre-pregnancy BMI ≥ 25 kg/m2. The assigned study treatment is delivered via four weekly online video consultations between gestational weeks 37-40. Participants assigned to AME meet with study personnel and a lactation consultant to learn and practice AME. Instructions are provided for home practice of AME between study visits. Control group participants view videos on infant care/development at study visits. Participants complete emailed surveys at enrollment (340/7-366/7 gestational weeks) and 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months postpartum. Surveys assess lactation and infant feeding practices; breastfeeding self-efficacy, attitudes, and satisfaction; perception of insufficient milk; onset of lactogenesis-II; lactation support and problems; and reasons for breastfeeding cessation. Surveys also assess factors associated with lactation outcomes, including demographic characteristics, health problems, birth trauma, racial discrimination, and weight stigma. Health information and infant feeding data are abstracted from the pregnancy and birth center electronic health record. Milk samples are collected from the intervention group at each study visit and from both groups at each postpartum follow-up for future analyses. Qualitative interviews are conducted at 6 weeks postpartum to understand AME experiences. Primary outcomes of interest are breastfeeding exclusivity and breastfeeding self-efficacy scores at 2 weeks postpartum. Outcomes will be examined longitudinally with generalized linear mixed-effects modeling. DISCUSSION: This is the first adequately powered trial evaluating the effectiveness of AME among U.S. birthing people and within a non-diabetic population with pre-pregnancy BMI ≥ 25 kg/m2. This study will also provide the first evidence of acceptability and effectiveness of telelactation-delivered AME. TRIAL REGISTRATION: ClinicalTrials.gov: NCT04258709.

Collateral benefits from a school-readiness intervention on breastfeeding: A cross-domain impact evaluation.

This study evaluated the collateral, or unanticipated, impacts of Smart Beginnings (SB), a two-site, tiered intervention designed to promote responsive parenting and school readiness, on breastfeeding intensity in a low-income sample. Impact analyses for the SB intervention were conducted using an intent-to-treat design leveraging a two-arm random assignment structure. Mothers assigned to the SB intervention group were more than three times more likely to give breastmilk as the only milk source at infant age 6 months than mothers assigned to the control group at one site, an effect not evident at the other study site. As development and growth are the two most salient domains of child health, understanding how interventions impact subsequent parenting practices across both domains is critical to address long-term economic and racial/ethnic disparities. Implications of the findings are discussed for improving the efficacy of interventions based on paediatric primary care.

Describing and Predicting Feeding Problems During the First 2 Years Within an Urban Pediatric Primary Care Center.

We conducted a prospective cohort study with children aged 6 to 18 months to identify predictors of feeding problems in an urban sample. Parent-reported child feeding problems (Montreal Children's Hospital Feeding Scale) and picky eating, parental anxiety (Generalized Anxiety Disorder 7), and family meal structure (Meals in Our Household) were assessed via a Web-based survey at 3 time points. Data analysis included descriptive statistics, correlations, and mixed-effects regression modeling. Eighty parents completed the survey. Child picky eating (r =.51) and resistance to try new foods (r = .30), parental anxiety (r = .34), rushed mealtimes (r = .28), and child age (r = .32) were significantly associated with child feeding problems. Feeding Scale scores were, on average, 6 points higher among picky eaters than those who were not over time (p < .001). Parent reports of picky eating early in life may warrant additional clinical investigation and referral to feeding specialists.

Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care: A Randomized Clinical Trial using the Family Check-Up.

This study evaluated acceptability, engagement in prevention, and efficacy of a primary care screening-and-referral-to-prevention program to reduce substance use in early adolescence. Screening tools were the Youth Risk Index and Transmissible Liability Index and prevention consisted of the Family Check-Up (FCU). Three hundred sixty-one 10- to 13-year-olds from low resource neighborhoods (85.9% African American; 52.4% female) screened "at risk" during primary care visits and were randomized to the FCU (n = 123) or usual care (n = 238). Screening was acceptable to parents and youths: nearly 95% of each rated it as important, about 90% of each were happy with or did not mind it, and only 2.4% of parents did not want their child to be screened at their next check-up. Of parents who had a chance to receive the FCU (or waitlist-control), 87.5% followed through with researchers while 93.5% who were offered FCU engaged in it. FCU efficacy primarily involved interactions such that youth with greater risk at baseline experienced larger benefits. At 12-month follow-up, FCU was associated with 11% reduced risk of initiating a new substance per substance that had been initiated before baseline; greater reductions in tolerance of deviance among those with higher tolerance of deviance at baseline; and a main effect of reduced anxiety, but no effect for conduct problems. Pediatric well-child check-up screening can identify high-risk youth before, or in the initial stages of, problematic SU; engage families in a preventive intervention; and reduce rates of substance use and related risk factors.

Increasing access to immediate postpartum contraceptive implants: a prospective clinical trial among patients with opioid use disorder.

OBJECTIVE: To evaluate the effects of increased access to immediate postpartum contraceptive implants (IPI) on repeat pregnancy and contraceptive use rates among patients with opioid use disorder (OUD). MATERIALS AND METHODS: Between 2016 and 2018, 194 postpartum patients with OUD were offered the option of IPI placement at an institution with limited immediate postpartum long-acting reversible contraception availability and followed for one-year postpartum. Differences in pregnancy rates between participants who did and did not choose IPI were examined using logistic regression with inverse probability of treatment weighting from propensity scores accounting for differences between the two groups. RESULTS: Among 194 participants, 96 (49.5%) chose an IPI and 98 (50.5%) chose an alternative method or no contraception (non-IPI). Among IPI participants, 76 (80.9%) continued to use their implant at one-year postpartum. Overall, 19 participants had a repeat pregnancy and 11 (57.9%) were unintended. In multivariable analyses, repeat pregnancy was more likely among those who did not choose IPI (OR 9.90; 95% CI 3.58-27.03) than those who did. Participants with OUD and who used alcohol (11.66; 1.38, 98.20) or cocaine (2.72; 1.23, 5.99) during pregnancy were more likely to choose IPI. Participants who were married (0.28; 0.09, 0.89), engaged in OUD treatment prior to pregnancy (0.48; 0.25, 0.93), and happier when they found out about their pregnancy (0.87; 0.77, 0.98) were less likely to choose IPI. CONCLUSION: Offering patients with OUD the option of IPI is associated with high utilisation and continuation rates, and low rates of repeat pregnancy within one-year postpartum.

Housing Insecurity, Housing Conditions, and Breastfeeding Behaviors for Medicaid-Eligible Families in Urban Settings.

BACKGROUND: Research exploring associations between exposure to social determinants of health and breastfeeding is needed to identify breastfeeding barriers. Housing insecurity and household conditions (chaos and crowding) may affect breastfeeding by increasing maternal stress and discomfort and decreasing time available to breastfeed. RESEARCH AIM: We aimed to examine the relationships between housing insecurity, breastfeeding exclusivity intention during the early postnatal period, and breastfeeding exclusivity at 6 months postpartum among a sample "at risk" for suboptimal breastfeeding rates. METHODS: This study is a secondary data analysis of a longitudinal study at two time periods. Data were collected from English- and Spanish-speaking, Medicaid-eligible mother-infant dyads (N = 361) at near-birth and child aged 6 months, in New York City and Pittsburgh. Structural equation modeling was used to examine direct and indirect effects of housing insecurity on breastfeeding exclusivity at child aged 6 months. RESULTS: The path model showed that experiencing more markers of housing insecurity (i.e., foreclosure/eviction threat, history of homelessness, late rent) was predictive of significantly lower breastfeeding exclusivity at 6 months. This was partially mediated through less exclusive breastfeeding intention during the early postnatal period. Greater household crowding was associated with 6-month breastfeeding exclusivity when mediated by intention. Household crowding had differential effects by study site and participant race/ethnicity. CONCLUSION: Refinement of housing insecurity as a multi-dimensional construct can lead to the development of standardized data collection instruments, inform future methodological decisions in research addressing social determinants of health, and can inform the development of responsive individual- and structural-level interventions.The data used in this study were collected as part of the SMART Beginnings Randomized Controlled Trial (NCT02459327 registered at ClinicalTrials.gov).

Individual differences in symptoms of maternal depression and associations with parenting behavior.

Links between global levels of maternal depressive symptoms and parenting behavior in early childhood are well established. However, depression is a heterogeneous disorder and little is known about how individual differences in depression symptoms may be differentially associated with different types of parenting behavior. We aimed to uncover nuance in the relationship between depression and parenting behavior by examining individual differences in symptoms of maternal depression and associations with parenting behavior with 2- and 3-year-old children. Participants included 714 diverse, low-income mothers and their 2-year-old children. Maternal depression symptoms were self-reported at child age 2. Three domains of parenting behavior (harsh, positive, and disengaged) were coded from mother-child interactions at ages 2 and 3. Individual differences in maternal depressive symptoms at child age 2 comprised five profiles: low, interpersonal rejection, moderate, high depressed affect and physical, and severe. Women with the high depressed affect and physical profile demonstrated the greatest risk for parenting challenges with higher levels of harsh parenting at child age 2 compared to all other profiles and higher levels of disengaged parenting at child age 3 compared to the low, moderate, and severe profiles. Unexpectedly, positive parenting did not differ by maternal depression profile at either age. There is wide heterogeneity in symptoms of depression among mothers of 2-year-old children that is clinically relevant for different dimensions of parenting. Physical and depressed affect symptoms in particular may present risk for harsh parenting. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Breastfeeding and Responsive Parenting as Predictors of Infant Weight Change in the First Year.

OBJECTIVE: To test breastfeeding duration and responsive parenting as independent predictors of infant weight change from birth to 12 months, and to test the moderating effect of a tiered parenting intervention on relations between breastfeeding and responsive parenting in relation to infant weight change. METHODS: Mother-infant dyads (N = 403) were participants in the ongoing Smart Beginnings (SB) randomized controlled trial testing the impact of the tiered SB parenting model that incorporates two evidence-based interventions: Video Interaction Project (VIP) and Family Check-Up (FCU). The sample was low income and predominantly Black and Latinx. Responsive parenting variables (maternal sensitivity and intrusiveness) came from coded observations of mother-infant interactions when infants were 6 months. Continuous weight-for-age (WFA) z-score change and infant rapid weight gain (RWG) from 0 to 12 months were both assessed. RESULTS: Longer breastfeeding duration was significantly associated with less WFA z-score change. The relationship between breastfeeding duration and WFA z-score change was significant only for infants in the intervention group. Intrusive parenting behaviors were also associated with greater WFA z-score change after accounting for breastfeeding duration. CONCLUSIONS: This study is one of the first to test both breastfeeding and parenting in relation to infant weight gain in the first year. Findings may have implications for family-focused child obesity prevention programs.

Improving Parent-Child Interactions in Pediatric Health Care: A Two-Site Randomized Controlled Trial.

BACKGROUND AND OBJECTIVES: Heterogeneity in risk among low-income families suggests the need for tiered interventions to prevent disparities in school readiness. Smart Beginnings (SB) integrates two interventions: Video Interaction Project (VIP) (birth to 3 years), delivered universally to low-income families in pediatric primary care, and Family Check-Up (6 months to 3 years), targeted home visiting for families with additional family risks. Our objective was to assess initial SB impacts on parent-child activities and interactions at 6 months, reflecting early VIP exposure. METHODS: Two-site randomized controlled trial in New York City (84% Latinx) and Pittsburgh (81% Black), with postpartum enrollment and random assignment to treatment (SB) or control. At 6 months, we assessed parent-child interactions through surveys (StimQ, Parenting Your Baby) and observation (video-recorded play, coded by using Parent-Child Interaction Rating Scales - Infant Adaptation). RESULTS: A total of 403 families were enrolled at child's birth (201 treatment) with 362 (89.8%) assessed at 6 months. Treatment families had increased StimQ, including total score (Cohen's d = 0.28; P < .001) and domains reflecting reading (d = 0.23; P = .02) and teaching (d = 0.25; P = .01), and Parent-Child Interaction Rating Scales - Infant Adaptation, including a cognitive stimulation factor (d = 0.40; P < .001) and domains reflecting support for cognitive development (d = 0.36; P < .001), and language quantity (0.40; P < .001) and quality (d = 0.37; P < .001). Thus, significant effects emerged across a broad sample by using varied methodologies. CONCLUSIONS: Findings replicate and extend previous VIP findings across samples and assessment methodologies. Examining subsequent assessments will determine impacts and feasibility of the full SB model, including potential additive impacts of Family Check-Up for families at elevated risk.

Maternal Psychological Well-Being and Infant Emergency Department Utilization.

BACKGROUND: A mother's psychological well-being impacts her own and her infant's health. Challenges to maternal psychological well-being (eg, depression, anxiety) are associated with increased infant emergency department (ED) utilization. It is not known if other maternal psychological factors, such as relational health and past maltreatment during one's own childhood, are also associated with child ED utilization. OBJECTIVE: Examine maternal psychological factors (ie, childhood maltreatment, mental health, and relational health) associated with infant ED utilization in the first year of life. DESIGN/METHODS: Participants included 120 economically disadvantaged women recruited into a prospective longitudinal study during pregnancy and followed across the first year of their child's life. Mothers reported number of infant ED visits from birth to 1 year (assessed 12-months postpartum), as well as on their own childhood maltreatment, relational health, and mental health (assessed prenatally). Associations between maternal experiences and infant ED utilization were assessed via bivariate correlations and regression analyses. RESULTS: Infants attended on average 0.79 ED visits (range 0-6). Maltreatment during the mother's own childhood, poor relational health, and prenatal mental health symptoms were each associated with greater infant ED visits; maternal age, income, and education were not. In a Poisson regression, childhood sexual abuse was the strongest predictor of infant ED utilization, followed by low acceptance from the mother's father figure and prenatal depression. CONCLUSIONS: Prenatal assessment of psychosocial factors may help identify risk for higher ED use. Women with psychosocial risk factors may need additional support establishing supportive primary and behavioral health care before and after birth.

Ledipasvir plus sofosbuvir in pregnant women with hepatitis C virus infection: a phase 1 pharmacokinetic study.

BACKGROUND: Hepatitis C virus (HCV) infection is increasing among pregnant women because of the opioid epidemic, yet there are no interventions to reduce perinatal HCV transmission or to treat HCV during pregnancy. Physiological changes in pregnancy alter the pharmacokinetics of some medications; thus, our aim was to compare the pharmacokinetic parameters of ledipasvir 90 mg plus sofosbuvir 400 mg during pregnancy with non-pregnant women. METHODS: This was an open-label, phase 1 study of pregnant women with genotype 1 HCV infection and their infants. A reference group of women who had participated in pharmacokinetic studies of ledipasvir-sofosbuvir during phase 2 and 3 trials was used. Participants were enrolled at Magee-Womens Hospital (Pittsburgh, PA, USA) between 23 and 24 weeks' gestation and had a 12-week course of oral ledipasvir-sofosbuvir (daily 90 mg ledipasvir plus 400 mg sofosbuvir). Three 12-h intensive pharmacokinetic visits were done at 25-26, 29-30, and 33-34 weeks' gestation and individual pharmacokinetics were summarised by geometric mean across the three visits. The primary outcome, analysed in all participants without suspected dosing errors, was the ledipasvir-sofosbuvir area under the concentration-time curve of the dosing interval (AUCtau) during pregnancy compared with the reference group by geometric mean ratio. This study is registered with ClinicalTrials.gov, NCT02683005. FINDINGS: From Oct 1, 2016, to Sept 30, 2018, 29 pregnant women were screened and nine (31%) were enrolled. Eight (89%) women were included in the primary analysis. Ledipasvir and sofosbuvir exposures were similar in the pregnant women versus the non-pregnant reference group (geometric mean ratio of AUCtau ledipasvir 89·3% [90% CI 68·7-116·1]; sofosbuvir 91·1% [78·0-106·3]). INTERPRETATION: Ledipasvir-sofosbuvir was safe and effective without clinically meaningful differences in drug exposure among pregnant versus non-pregnant women. FUNDING: National Institutes of Health/Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institutes of Health/Office of Research on Women's Health, and Gilead Sciences.

The Development and Evaluation of a Text Message Program to Prevent Perceived Insufficient Milk Among First-Time Mothers: Retrospective Analysis of a Randomized Controlled Trial.

BACKGROUND: Several recent trials have examined the feasibility and efficacy of automated SMS text messaging to provide remote breastfeeding support to mothers, but these texting systems vary in terms of design features and outcomes examined. OBJECTIVE: This study examined user engagement with and feedback on a theory-grounded SMS text messaging intervention intended to prevent perceived insufficient milk (PIM)-the single, leading modifiable cause of unintended breastfeeding reduction and cessation. METHODS: We recruited 250 nulliparous individuals intending to breastfeed between 13 and 25 weeks of pregnancy in southwestern Pennsylvania. Participants were randomly assigned with equal allocation to either an SMS intervention to prevent PIM and unintended breastfeeding reduction or cessation (MILK, a Mobile, semiautomated text message-based Intervention to prevent perceived Low or insufficient milK supply; n=126) or a control group receiving general perinatal SMS text messaging-based support via the national, free Text4Baby system (n=124). Participants in both groups received SMS text messages 3 to 7 times per week from 25 weeks of pregnancy to 8 weeks postpartum. The MILK intervention incorporated several automated interactivity and personalization features (eg, keyword texting for more detailed information on topics and branched response logic) as well as an option to receive one-on-one assistance from an on-call study lactation consultant. We examined participant interactions with the MILK system, including response rates to SMS text messaging queries. We also sought participant feedback on MILK content, delivery preferences, and overall satisfaction with the system via interviews and a remote survey at 8 weeks postpartum. RESULTS: Participants randomized to MILK (87/124, 70.2% white and 84/124, 67.7% college educated) reported that MILK texts increased their breastfeeding confidence and helped them persevere through breastfeeding problems. Of 124 participants, 9 (7.3%) elected to stop MILK messages, and 3 (2.4%) opted to reduce message frequency during the course of the study. There were 46 texts through the MILK system for individualized assistance from the study lactation consultant (25/46, 54% on weekends or after-hours). The most commonly texted keywords for more detailed information occurred during weeks 4 to 6 postpartum and addressed milk volume intake and breastfeeding and sleep patterns. MILK participants stated a preference for anticipatory guidance on potential breastfeeding issues and less content addressing the benefits of breastfeeding. Suggested improvements included extending messaging past 8 weeks, providing access to messaging for partners, and tailoring content based on participants' pre-existing breastfeeding knowledge and unique breastfeeding trajectory. CONCLUSIONS: Prenatal and postpartum evidence-based breastfeeding support delivered via semiautomated SMS text messaging is a feasible and an acceptable intervention for first-time mothers. To optimize engagement with digital breastfeeding interventions, enhanced customization features should be considered. TRIAL REGISTRATION: ClinicalTrials.gov NCT02724969; https://clinicaltrials.gov/ct2/show/NCT02724969.

Pharmacotherapy for depression and bipolar disorder during lactation: A framework to aid decision making.

OBJECTIVE: Breastmilk is recommended as the exclusive source of nutrition for infants younger than 6 months due to the numerous health benefits for both infants and mothers. Although many women are prescribed medications during pregnancy and postpartum, limited data are available to assist women in weighing the benefits compared to the risks of peripartum medication use. The goals of this paper are to discuss the importance of breastmilk for the health of both the mother and infant, evaluate the impact of medication use on women's infant feeding choice, describe the transfer of drugs to breastmilk and infants, and provide a framework for clinicians to support evidence-based counseling for women treated for mood disorders. RECOMMENDATIONS: We recommend early pregnancy counseling to discuss the benefits and risks of medications during breastfeeding. The Surgeon General's Call to Action (2011) highlights the short and long-term negative health effects of not providing breastmilk. Integrating recommendations from the pediatric and obstetric teams allows patients to make decisions based on evidence and reach their infant feeding goals. Databases containing summaries of research findings and pharmacologic properties of the drug of interest are an essential resource for clinicians.

Five-Year Outcomes Among Medicaid-Enrolled Children With In Utero Opioid Exposure.

The health of women and children affected by opioid use disorder is a priority for state Medicaid programs. Little is known about longer-term outcomes among Medicaid-enrolled children exposed to opioids in utero. We examined well-child visit use and diagnoses of pediatric complex chronic conditions in the first five years of life among children with opioid exposure, tobacco exposure, or neither exposure in utero. The sample consisted of 82,329 maternal-child dyads in the Pennsylvania Medicaid program in which the children were born in the period 2008-11 and followed up for five years. Children with in utero opioid exposure had a lower predicted probability of recommended well-child visit use at age fifteen months (42.1 percent) compared to those with tobacco exposure (54.1 percent) and those with neither exposure (55.7 percent). Children with in utero opioid exposure had a predicted probability of being diagnosed with a pediatric complex chronic condition similar to that among children with tobacco exposure and those with neither exposure (20.4 percent, 18.7 percent, and 20.2 percent, respectively). Our findings were consistent when we examined a subgroup of opioid-exposed children identified as having neonatal opioid withdrawal symptoms.

Neurodevelopmental Outcomes of Neonates Randomized to Morphine or Methadone for Treatment of Neonatal Abstinence Syndrome.

OBJECTIVE: To evaluate the effects of pharmacologic treatment of neonatal abstinence syndrome on neurodevelopmental outcome from a randomized, controlled trial. STUDY DESIGN: Eight sites enrolled 116 full-term newborn infants with neonatal abstinence syndrome born to mothers maintained on methadone or buprenorphine into a randomized trial of morphine vs methadone. Ninety-nine infants (85%) were evaluated at hospital discharge using the NICU Network Neurobehavioral Scale. At 18 months, 83 of 99 infants (83.8%) were evaluated with the Bayley Scales of Infant and Toddler Development-Third Edition and 77 of 99 (77.7%) with the Child Behavior Checklist (CBCL). RESULTS: Primary analyses showed no significant differences between treatment groups on the NICU Network Neurobehavioral Scale, Bayley Scales of Infant and Toddler Development-Third Edition, or CBCL. However in post hoc analyses, we found differences by atypical NICU Network Neurobehavioral Scale profile on the CBCL. Infants receiving adjunctive phenobarbital had lower Bayley Scales of Infant and Toddler Development-Third Edition scores and more behavior problems on the CBCL. In adjusted analyses, internalizing and total behavior problems were associated with use of phenobarbital (P = .03; P = .04), maternal psychological distress (measured by the Brief Symptom Inventory) (both P < .01), and infant medical problems (both P = .02). Externalizing problems were associated with maternal psychological distress (P < .01) and continued maternal substance use (P < .01). CONCLUSIONS: Infants treated with either morphine or methadone had similar short-term and longer term neurobehavioral outcomes. Neurodevelopmental outcome may be related to the need for phenobarbital, overall health of the infant, and postnatal caregiving environment. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01958476.

Adolescent and Parent Knowledge, Attitudes, and Perceptions of Harm of Household Controlled Medications.

Introduction: Adolescents learn knowledge, attitudes, and behaviors from their parents, yet little is known about how these attributes are associated with management of household controlled prescription medications. We aimed to assess adolescent and parent: 1) knowledge and attitudes regarding household controlled medications, including previous healthcare counseling; 2) perceptions of harm of medication misuse and diversion; and 3) potential associations of these attributes with household management. Methods: This was a cross-sectional study with paired data using brief, online, confidential surveys of adolescents and parents via an adolescent medicine clinic associated with a large academic center. Eligible adolescents were aged 12-18 years old with at least one controlled prescription medication in the home. Data collection and analysis occured in 2017-2018. Results: Of the 243 adolescent-parent dyads, many adolescents and parents had: low knowledge (15%; 6%), risky attitudes (31%; 32%), received healthcare counseling on safe management of controlled medications (30%; 96%), and low perceived harm of adolescent diversion (39%; 49%). Parents practicing unsafe household management were 2.4 (95% CI = 1.3, 4.3) times as likely to have risky attitudes. Adolescents with families practicing unsafe medication management were 3.7 (95% CI = 1.1, 10.4) times as likely to have low perceptions of harm from diversion. Conclusions: Many adolescents and parents have low knowledge, risky attitudes, and low perceptions of harm of adolescent diversion, some of which are associated with unsafe household medication management. Providers should aim to utilize interventions to improve these attributes for adolescents and parents to enhance safe household medication management.

Breastfeeding Behaviors and Maternal Interaction Quality in a Low-Income, Ethnic Minority Population.

OBJECTIVE: To examine the associations between breastfeeding intensity and underexplored features of maternal-child interaction quality over and above the influence of breastfeeding initiation. METHODS: The current study leveraged an on-going, multisite randomized controlled trial of a tiered parenting program for 462 Medicaid-eligible mothers and their infants in the United States. We examined whether breastfeeding intensity and exclusivity was associated with observed maternal sensitivity, intrusiveness, and detachment, as well as self-reported maternal verbal responsiveness, 6 months infant age. Analyses controlled for breastfeeding initiation, demographics, and early parenting experiences. RESULTS: Higher intensity breastfeeding at 6 months was significantly related to higher maternal sensitivity (ß = 0.12, p = 0.004) and lower maternal intrusiveness (ß = -0.10, p = 0.045). There was no significant association between breastfeeding intensity at 6 months and detachment (ß = -0.02, no significant [ns]) or self-reported verbal responsiveness (ß = 0.11, ns). Results were the same when intensity was measured as a dichotomous indicator for exclusive breastfeeding. Effect sizes were small-to-moderate, ranging from Cohen's d = 0.26 to 0.31. Associations did not vary by site, race/ethnicity, infant difficultness, or household poverty. CONCLUSION: The finding that breastfeeding intensity was significantly and independently associated with maternal sensitivity and intrusiveness is novel in the literature on low-income families from the United States. These findings have implications for breastfeeding promotion strategies and indicate that future research should explore synergistic or spillover effects of interventions aimed at maternal-child interaction quality into the infant feeding domain, particularly in the primary care setting.

Feasibility and Effectiveness of Telelactation Among Rural Breastfeeding Women.

OBJECTIVE: To evaluate the feasibility and impact of telelactation via personal electronic devices on breastfeeding duration and exclusivity among rural women. METHODS: The Tele-MILC trial, a pragmatic, parallel design trial, recruited 203 women during their postpartum hospitalization in a critical access hospital in Pennsylvania and randomized them to receive telelactation (n = 102) or usual care (n = 101). We used intent-to-treat (ITT) and instrumental variable (IV) approaches to analyze study data for the 187 participants who completed follow-up. The primary outcomes were any breastfeeding and exclusive breastfeeding at 12 weeks postpartum. RESULTS: Among participants in the telelactation arm, 50% (47/94) reported participating in video calls. At 12 weeks, 71% of participants in the telelactation arm versus 68% of control participants were breastfeeding in the ITT model (3% difference, P = .73), whereas 73% of participants in the telelactation arm versus 68% of control participants were breastfeeding in the IV model (5% difference, P = .74). Among participants who were still breastfeeding at 12 weeks, 51% participants in the telelactation arm were breastfeeding exclusively versus 46% of control participants in the ITT model (5% difference, P = .47), whereas 56% of participants in the telelactation arm were breastfeeding exclusively versus 45% of control participants in the IV model (11% difference, P = .48). In all models, participants in the telelactation arm were breastfeeding at higher rates; however, differences were not statistically significant. CONCLUSIONS: This trial demonstrated that telelactation can be implemented with a rural underserved population. Though this trial was not powered to detect differences in breastfeeding duration and exclusivity, and none were observed, telelactation remains a promising approach for further investigation. ClinicalTrials.gov Identifier: NCT02870413.