Carl Seashore

Buprenorphine and Naloxone Compared With Methadone Treatment in Pregnancy

OBJECTIVE: To compare neonatal abstinence syndrome prevalence and characteristics among neonates born to women prescribed buprenorphine and naloxone compared with methadone during pregnancy. METHODS: Retrospective cohort analysis of mother–neonate dyads treated with either buprenorphine and naloxone or methadone during pregnancy. Primary neonatal outcomes included diagnosis of neonatal abstinence syndrome, neonatal abstinence syndrome peak scores, total amount of morphine used to treat neonatal abstinence syndrome (mg), and duration of treatment for neonatal abstinence syndrome (days). Secondary outcomes included head circumference, birth weight, length, preterm birth, neonatal intensive care unit admission, Apgar scores, and overall length of hospitalization. RESULTS: From January 1, 2011, to November 30, 2013, we identified 62 mother–neonate dyads, 31 treated with methadone and 31 treated with buprenorphine and naloxone. Sixteen neonates (51.6%) in the methadone group were diagnosed with neonatal abstinence syndrome compared with eight (25.1%) in the buprenorphine and naloxone group (adjusted odds ratio 2.55, 95% confidence interval [CI] 1.31–4.98, P=.01). The buprenorphine and naloxone-exposed neonates had lower peak neonatal abstinence syndrome scores (9.0±4.4 compared with 10.7±3.7, multivariate-adjusted mean difference=−2.77, 95% CI −4.99 to −0.56, P=.02) and shorter overall hospitalization (5.6±5.0 compared with 9.8±7.4 days, multivariate-adjusted mean difference=−3.90, 95% CI, −7.13 to −0.67, P=.02). We found no other differences in primary or secondary outcomes. CONCLUSION: In a cohort of pregnant patients treated with either methadone or buprenorphine and naloxone in pregnancy, newborns exposed to maternal buprenorphine and naloxone had less frequent neonatal abstinence syndrome. Additionally, neonates exposed to buprenorphine and naloxone had shorter overall hospitalization lengths. LEVEL OF EVIDENCE: II

Neonatal Outcomes and their Relationship to Maternal Buprenorphine Dose during Pregnancy

BACKGROUND Buprenorphine pharmacotherapy for opioid-dependent pregnant women is associated with maternal and neonatal outcomes superior to untreated opioid dependence. However, the literature is inconsistent regarding the possible existence of a dose-response relationship between maternal buprenorphine dose and neonatal clinical outcomes. METHODS The present secondary analysis study (1) examined the relationship between maternal buprenorphine dose at delivery and neonatal abstinence syndrome (NAS) peak score, estimated gestational age at delivery, Apgar scores at 1 and 5 min, neonatal head circumference, length, and weight at birth, amount of morphine needed to treat NAS, duration of NAS treatment, and duration of neonatal hospital stay and (2) compared neonates who required pharmacotherapy for NAS to neonates who did not require such pharmacotherapy on these same outcomes, in 58 opioid-dependent pregnant women receiving buprenorphine as participants in a randomized clinical trial. RESULTS (1) Analyses failed to provide evidence of a relationship between maternal buprenorphine dose at delivery and any of the 10 outcomes (all p-values>.48) and (2) significant mean differences between the untreated (n=31) and treated (n=27) for NAS groups were found for duration of neonatal hospital stay and NAS peak score (both p-values<.001). CONCLUSIONS (1) Findings failed to support the existence of a dose-response relationship between maternal buprenorphine dose at delivery and any of 10 neonatal clinical outcomes, including NAS severity and (2) that infants treated for NAS had a higher mean NAS peak score and, spent a longer time in the hospital than did the group not treated for NAS is unsurprising.

Neonatal abstinence syndrome: Presentation and treatment considerations

The increase in opioid use among the general population is reflected in pregnant women and neonatal abstinence syndrome (NAS) statistics. This increase has produced an unprecedented focus on NAS from both the political-judicial sphere and the medical community. Under the banner of fetal protection, judges and prosecutors have implemented punitive approaches against women who use prescribed and nonprescribed opioids during pregnancy, including arrest, civil commitment, detention, prosecution, and loss of custody or termination of parental rights. Within the medical community, questions have been raised regarding protocols to detect prenatal drug exposure at delivery, NAS treatment protocols, the need for quality-improvement strategies to standardize care and reduce length of stay for mother and infant, and the benefits of engaging the mother in the care of her infant. It is not uncommon for the expression of strong discordant views on these issues both between and among these political-judicial and medical constituencies. Closely examining the issues often reveal a lack of understanding of substance use disorders, their treatment, and the occurrence and treatment of NAS. This study provides an in-depth examination of NAS, including variations in presentation and factors that impact the efficacy of treatment, and also identifying questions that remain unanswered. Finally, 4 key areas on which future research should focus to guide both medical care and public policy are discussed.

Measurement of neonatal abstinence syndrome: Evaluation of short forms

OBJECTIVES 1) How well do the short forms previously developed from the Maternal Opioid Treatment: Human Experimental Research (MOTHER) neonatal abstinence syndrome (NAS) scale (MNS) discriminate between neonates untreated and treated for NAS? (2) Can a short form be developed that is superior to other short forms in discriminating between the two groups? DESIGN/PARTICIPANTS This secondary analysis study used data from 131 delivered neonates in the MOTHER study, a randomized controlled trial comparing neonatal and maternal outcomes in opioid-dependent pregnant women administered buprenorphine or methadone. SETTING Comprehensive care was provided at seven university hospitals. OUTCOME MEASURES A 19-item instrument measuring neonatal abstinence signs. RESULTS A five-item index proved superior to the previous indices (ps < 0.01) and discriminated between the treated and untreated NAS groups as well as did the MNS total score (p=0.09). CONCLUSIONS A short form developed from the MNS shows promise as a possible screening measure.

Translating Clinical Guidelines Into Practice: Challenges and Opportunities in a Dynamic Health Care Environment

Clinical practice guidelines are evidence-based recommendations with the potential to improve population health, yet they remain inconsistently utilized. In this commentary we discuss barriers and drivers to implementing clinical practice guidelines. We also suggest ways to support their translation into practice.

Neonatal abstinence syndrome management: A review of recent evidence

BACKGROUND The evaluation and management of infants with neonatal abstinence syndrome (NAS), the constellation of opioid withdrawal specific to newborns, have received renewed attention over the past decade during a new epidemic of opioid use, misuse, abuse, and dependence. Infants with NAS often endure long and costly hospital stays. OBJECTIVE We aim to review recent literature on the management and outcomes of infants with, and at risk for, opioid withdrawal. METHODS We reviewed articles indexed in PubMed over the past 5 years that examined interventions and/or outcomes related to the management of infants with NAS. Thirty-seven studies were included in our review comprising 8 categories: 1) identification of infants at risk for NAS, 2) prenatal factors, 3) evaluation of signs and symptoms, 4) non-pharmacologic care, including rooming-in and breastfeeding, 5) standardization of traditional protocols, 6) pharmacologic management, 7) alternative treatment approaches, and 8) long-term outcomes. RESULTS Non-pharmacologic interventions, standardization of traditional protocols, and alternative treatment approaches were all associated with improved outcomes. Lengths of stay were generally lowest in the studies of non-pharmacologic interventions. Patients exposed to buprenorphine in utero tended to have better short-term outcomes than those exposed to methadone. Longer-term outcomes for infants with NAS appear to be worse than those of control groups. CONCLUSION The current epidemic necessitates both continued research, and the application of new evidence-based practices in the assessment and treatment of newborns exposed to opioids in utero. Projects focused on non-pharmacologic interventions appear to hold the most promise.

A Quality-Improvement Initiative to Reduce NICU Transfers for Neonates at Risk for Hypoglycemia

This is a quality-improvement project that decreased hypoglycemia and NICU transfers by using early SSC placement and early feeding for at-risk infants. BACKGROUND AND OBJECTIVE: Neonatal hypoglycemia is a common problem, often requiring management in the NICU. Nonpharmacologic interventions, including early breastfeeding and skin-to-skin care (SSC), may prevent hypoglycemia and the need to escalate care. Our objective was to maintain mother-infant dyads in the mother-infant unit by decreasing hypoglycemia resulting in NICU transfer. METHODS: Inborn infants ≥35 weeks’ gestation with at least 1 risk factor for hypoglycemia were included. Using quality-improvement methodology, a bundle for at-risk infants was implemented, which included a protocol change focusing on early SSC, early feeding, and obtaining a blood glucose measurement in asymptomatic infants at 90 minutes. The primary outcome was the overall transfer rate of at-risk infants to the NICU. Secondary outcomes were related to protocol adherence. Balancing measures, including the rate of symptomatic hypoglycemia and sepsis evaluations, were monitored. Statistical process control charts using standard interpretation rules were used to monitor for improvement in key aims. RESULTS: For infants at risk for hypoglycemia, the NICU transfer rate decreased from 17% to 3% overall. Documented early feeding and SSC in at-risk newborns increased. The percent of at-risk infants transferred to the NICU who did not require intravenous dextrose decreased from 5% at baseline to 0.7% after intervention. There were no adverse outcomes observed in the period before or after the intervention. CONCLUSIONS: The implementation of a quality-improvement intervention promoting SSC and early feeding in at-risk infants was associated with a decreased rate of transfer to the NICU for hypoglycemia.

Factors Associated With Refusal of Intramuscular Vitamin K in Normal Newborns

The frequency of IM vitamin K administration refusal in a national network of well newborn units in the United States was 0.6%. BACKGROUND AND OBJECTIVE: Refusal of intramuscular (IM) vitamin K administration by parents is an emerging problem. Our objective was to assess the frequency of and factors associated with refusal of IM vitamin K administration in well newborns in the United States. METHODS: We determined the number of newborns admitted to well newborn units whose parents refused IM vitamin K administration in the Better Outcomes through Research for Newborns network and, in a nested patient-control study, identified factors associated with refusal of IM vitamin K administration by using a multiple logistic regression model. RESULTS: Of 102 878 newborns from 35 Better Outcomes through Research for Newborns sites, parents of 638 (0.6%) refused IM vitamin K administration. Frequency of refusal at individual sites varied from 0% to 2.3%. Exclusive breastfeeding (adjusted odds ratio [aOR] = 3.4; 95% confidence interval [CI]: 2.1–5.5), non-Hispanic white race and/or ethnicity (aOR = 1.7; 95% CI: 1.2–2.4), female sex (aOR = 1.6; 95% CI: 1.2–2.3), gestational age (aOR = 1.2; 95% CI: 1.1–1.4), and mother’s age (aOR = 1.05; 95% CI: 1.02–1.08) were significantly associated with refusal of IM vitamin K administration. Refusal of the administration of both ocular prophylaxis and hepatitis B vaccine was also strongly associated with refusal of IM vitamin K administration (aOR = 88.7; 95% CI: 50.4–151.9). CONCLUSIONS: Refusal of IM vitamin K by parents of newborns is a significant problem. Interventions to minimize risks to these newborns are needed.

Preventing Newborn Falls and Improving Care for Postpartum Women and Their Newborns

In their article, “Newborn Falls in a Large Tertiary Academic Center Over 13 Years,” Loyal et al1 report a retrospective review of newborn falls at a hospital birthing facility over a period of >10 years. This study is important because it reveals a problem that has recently garnered attention from The Joint Commission as being one that is not sufficiently understood.2 Birth is the most common reason for hospitalization in the United States, and although newborn falls are uncommon, it is a serious adverse event for patients, parents, and hospital staff when they do occur. Falls among hospitalized adults are ∼10- to 20-fold more common than falls among newborns, with the former having an occurrence rate of 3.56 falls per 1000 patient days, according to the authors of a recent study.3 In the study reported in this issue, the authors found a fall rate of 4.6 falls per 10 000 live births, or ∼2 falls per 10 000 patient days. Although the rate of infant falls during postpartum hospitalization is comparatively small, anyone who has experienced a newborn fall is well aware of the distress and potential harm that are caused when this does occur. We as clinicians and hospital administrators want to implement every step …

Giving Birth to Evidence-Based Care for Newborns

Benjamin Franklin is widely credited with saying, “In this world nothing can be said to be certain, except death and taxes,” and it follows that birth is assumed to have occurred before these 2 events. In fact, as the authors of the Better Outcomes Through Research for Newborns (BORN) Delphi study1 note in this issue, birth is by far the most common reason for pediatric care in a hospital setting in the United States. The Centers for Disease Control and Prevention recently reported that the rate of out-of-hospital births in the United States has risen to 1.36% in 2012,2 but most infants born in the United States are cared for in hospitals. As providers of care to newborns we must ask ourselves, “On what basis are we determining the best care for these infants?” For some practices, such as administering hepatitis B vaccine and vitamin K at the time …