Biological Testing and Interpretation of Laboratory Results Associated with Detecting Newborns with Substance Exposure.

BACKGROUND: Substance use during pregnancy is common, as is biological testing that is intended to help identify prenatal exposures. However, there is no standardized requirement for biological testing with either maternal or newborn specimens, nor is there standardization related to when testing occurs, how frequently testing occurs, what specimen(s) to test, what substances to test for, or how to perform testing. CONTENT: We review common specimen types tested to detect maternal and newborn substance exposure with a focus on urine, meconium, and umbilical cord tissue. We also review common analytical methods used to perform testing, including immunoassay, and mass spectrometry platforms. Considerations regarding the utilization of testing relative to the purpose of testing, the drug analyte(s) of interest, the specific testing employed, and the interpretation of results are emphasized to help guide decisions about clinical utilization of testing. We also highlight specific examples of unexpected results that can be used to guide interpretation and appropriate next steps. SUMMARY: There are strengths and limitations associated with all approaches to detecting substance exposure in pregnant persons as well as biological testing to evaluate a newborn with possible substance exposure. Standardization is needed to better inform decisions surrounding evaluation of substance exposures in pregnant people and newborns. If biological sampling is pursued, testing options and results must be reviewed in clinical context, acknowledging that false-positive and -negative results can and do occur.

Safe to Sleep in Tennessee: A Statewide Quality Improvement Initiative.

OBJECTIVE: Sleep-related deaths were the fourth leading cause of infant death in Tennessee between 2014 and 2018. In response, the Tennessee Initiative for Perinatal Quality Care developed a statewide quality improvement project, which focused on the demonstration and enforcement of a safe sleep environment in participating birthing hospitals to help families learn and practice the same at home. The project's aim was to improve the percent of infants audited for safe sleep practices (0-12 mo of age, cared for in participating newborn nurseries or neonatal intensive care units) that were compliant with the practices recommended by the 2016 American Academy of Pediatrics (AAP) Task Force on Sudden Infant Death Syndrome. STUDY DESIGN: Participating teams were required to develop and implement safe sleep policies in compliance with the AAP recommendations, provide safe sleep education to staff and families, and complete monthly safe sleep audits. A tool was provided to assess whether each audited infant was compliant with safe sleep recommendations and any reason(s) the infant was not compliant. Teams met virtually for monthly huddles and semiannual learning sessions to discuss the development and testing of change ideas. RESULTS: The project teams were able to improve the percent of infants audited that were compliant with safe sleep recommendations by 22% over the course of the project. Audits revealed the main reasons for noncompliance were additional objects in the crib (49%, 329/671), unsafe bedding (27%, 181/671), and head of bed elevation (24%, 164/671). CONCLUSION: This project demonstrates the positive impact that a statewide quality improvement initiative can have on identifying and addressing barriers, sharing resources and education, and monitoring local and statewide data, which led to increased compliance with safe sleep recommendations in the hospital. Safe sleep education and monitoring should be ongoing as new parents and staff always need to be educated on safe sleep principles. KEY POINTS: · In 2020, 25% of all infant deaths in Tennessee were due to an unsafe sleep environment.. · Sleep-related deaths in infants are frequently preventable.. · State quality improvement projects are effective in increasing safe sleep compliance.. · State perinatal quality collaboratives can partner with their State Department of Health, local hospitals, and providers, to increase awareness, educate parents, and model a safe sleep environment..

Evaluating Definitions for Neonatal Abstinence Syndrome.

BACKGROUND AND OBJECTIVES: National estimates indicate that the incidence of neonatal abstinence syndrome (NAS), a postnatal opioid withdrawal syndrome, increased more than fivefold between 2004 and 2016. There is no gold standard definition for capturing NAS across clinical, research, and public health settings. Our objective was to evaluate how different definitions of NAS modify the calculated incidence when applied to a known population of opioid-exposed infants. METHODS: Data for this retrospective cohort study were obtained from opioid-exposed infants born at Vanderbilt University Medical Center in 2018. Six commonly used clinical and surveillance definitions of opioid exposure and NAS were applied to the study population and evaluated for accuracy in assessing clinical withdrawal. RESULTS: A total of 121 opioid-exposed infants met the criteria for inclusion in our study. The proportion of infants who met criteria for NAS varied by predefined definition, ranging from 17.4% for infants who received morphine to 52.8% for infants with the diagnostic code for opioid exposure. Twenty-eight infants (23.1%) received a clinical diagnosis of NAS by a medical provider, and 38 (34.1%) received the diagnostic code for NAS at discharge. CONCLUSIONS: We found significant variability in the incidence of opioid exposure and NAS among a single-center population using 6 common definitions. Our findings suggest a need to develop a gold standard definition to be used across clinical, research, and public health surveillance settings.

Improving the Discharge Process for Opioid-Exposed Neonates.

OBJECTIVES: Opioid-exposed neonates (OENs) are a population at risk for postdischarge complications. Our objective was to improve completion of a discharge bundle to connect patients with outpatient resources to mitigate postdischarge risks. METHODS: Team Hope, a hospital-wide initiative to improve the care of OENs, examined the completion of a discharge bundle from September 2017 through February 2019. A complete discharge bundle was defined as referral to a primary care physician, referral to early intervention services, referral to in-home nursing assessment and educational services, referral to the development clinic if diagnosed with neonatal abstinence syndrome, and referral to the gastroenterology or infectious disease clinic if exposed to hepatitis C virus. After obtaining baseline data, simple interventions were employed as education of providers, social workers, and case management; reminder notes in the electronic health record; and biweekly reminders to resident physicians. A statistical process control chart was used to analyze our primary measure, with special cause variation resulting in a shift indicated by 8 consecutive points above or below the mean line. RESULTS: One hundred nineteen OENs were examined with an initial discharge bundle completion of 2.6% preimplementation. Referral to early intervention services and the development clinic were the least successfully completed elements before intervention implementation. After the development of the discharge bundle in July 2018, special cause variation was achieved, resulting in a mean-line shift with 60.3% now having a complete bundle for 83 OENs. CONCLUSIONS: We implemented a standardized discharge bundle that improved our discharge processes for OENs.

Umbilical Cord Tissue and Meconium May Not Be Equivalent for Confirming in Utero Substance Exposure.

In a retrospective study of 501 neonates with potential in utero substance exposure, the drug detection performance of a commercially available umbilical cord tissue toxicology test was evaluated against a commercially available gold standard meconium toxicology test. Drugs detected in paired meconium and umbilical cord tissue samples were often discordant.

A Statewide Quality Improvement Collaborative to Increase Breastfeeding Rates in Tennessee.

BACKGROUND AND OBJECTIVES: Tennessee has low breastfeeding rates and has identified opportunities for improvement to enhance maternity practices to support breastfeeding mothers. We sought a 10% relative increase in the aggregate Joint Commission measure of breastfeeding exclusivity at discharge (TJC PC-05) by focusing on high-reliability (≥90%) implementation of processes that promote breastfeeding in the delivery setting. METHODS: A statewide, multidisciplinary development team reviewed evidence from the WHO-UNICEF "Ten Steps to Successful Breastfeeding" to create a consensus toolkit of process indicators aligned with the Ten Steps. Hospitals submitted monthly TJC PC-05 data for 6 months while studying local implementation of the Ten Steps to identify improvement opportunities, and for an additional 11 months while conducting tests of change to improve Ten Steps implementation using Plan-Do-Study-Act cycles, local process audits, and control charts. Data were aggregated at the state level and presented at 12 monthly webinars, 3 regional learning sessions, and 1 statewide meeting where teams shared their local data and implementation experiences. RESULTS: Thirteen hospitals accounting for 47% of live births in Tennessee submitted data on 31,183 mother-infant dyads from August 1, 2012, to December 31, 2013. Aggregate monthly mean PC-05 demonstrated "special cause" improvement increasing from 37.1% to 41.2%, an 11.1% relative increase. Five hospitals reported implementation of ≥5 of the Ten Steps and two hospitals reported ≥90% reliability on ≥5 of the Ten Steps using locally designed process audits. CONCLUSION: Using large-scale improvement methodology, a successful statewide collaborative led to >10% relative increase in breastfeeding exclusivity at discharge in participating Tennessee hospitals. Further opportunities for improvement in implementing breastfeeding supportive practices were identified.

Tonsillectomy Versus Watchful Waiting for Recurrent Throat Infection: A Systematic Review.

CONTEXT: The effectiveness of tonsillectomy or adenotonsillectomy ("tonsillectomy") for recurrent throat infection compared with watchful waiting is uncertain. OBJECTIVE: To compare sleep, cognitive, behavioral, and health outcomes of tonsillectomy versus watchful waiting in children with recurrent throat infections. DATA SOURCES: MEDLINE, Embase, and the Cochrane Library. STUDY SELECTION: Two investigators independently screened studies against predetermined criteria. DATA EXTRACTION: One investigator extracted data with review by a second. Investigators independently assessed risk of bias and strength of evidence (SOE) and confidence in the estimate of effects. RESULTS: Seven studies including children with ≥3 infections in the previous 1 to 3 years addressed this question. In studies reporting baseline data, number of infections/sore throats decreased from baseline in both groups, with greater decreases in sore throat days, clinician contacts, diagnosed group A streptococcal infections, and school absences in tonsillectomized children in the short term (<12 months). Quality of life was not markedly different between groups at any time point. LIMITATIONS: Few studies fully categorized infection/sore throat severity; attrition was high. CONCLUSIONS: Throat infections, utilization, and school absences improved in the first postsurgical year in tonsillectomized children versus children not receiving surgery. Benefits did not persist over time; longer-term outcomes are limited. SOE is moderate for reduction in short-term throat infections and insufficient for longer-term reduction. SOE is low for no difference in longer-term streptococcal infection reduction. SOE is low for utilization and missed school reduction in the short term, low for no difference in longer-term missed school, and low for no differences in quality of life.

Prevention of Vitamin K Deficiency Bleeding.

The risk that a newborn will develop vitamin K deficiency bleeding is 1700/100,000 (one out of 59) if vitamin K is not administered. When intramuscular vitamin K is administered, the risk of vitamin K deficiency bleeding is reduced to 1/100,000. While women may have misconceptions about vitamin K prophylaxis for their newborns, health care providers should be prepared with factual information. Prophylaxis is needed even for healthy newborns without risk factors for bleeding. Other forms of vitamin K supplementation, including oral administration of Food and Drug Administration-approved vitamin K preparations and maternal supplements during pregnancy or lactation, do not have the same effectiveness as the parenteral form. The formulations of vitamin K approved for use in the United States have not been associated with childhood leukemia or other childhood health problems. Care providers need to give accurate information to families regarding the risks and benefits of vitamin K prophylaxis. An interprofessional approach to education can be effective in increasing acceptance of vitamin K prophylaxis and decreasing the incidence of vitamin K deficiency bleeding. This article uses a case study approach to highlight common misconceptions about vitamin K prophylaxis and discuss a recent interprofessional collaboration to prevent vitamin K deficiency bleeding.

Pharmacologic Interventions for Infantile Hemangioma: A Meta-analysis.

CONTEXT: Infantile hemangiomas (IH) may be associated with significant functional impact. OBJECTIVE: The objective of this study was to meta-analyze studies of pharmacologic interventions for children with IH. DATA SOURCES: Data sources were Medline and other databases from 1982 to June 2015. STUDY SELECTION: Two reviewers assessed studies using predetermined inclusion criteria. DATA EXTRACTION: One reviewer extracted data with review by a second. RESULTS: We included 18 studies in a network meta-analysis assessing relative expected rates of IH clearance associated with ß-blockers and steroids. Oral propranolol had the largest mean estimate of expected clearance (95%; 95% Bayesian credible interval [BCI]: 88%-99%) relative to oral corticosteroids (43%, 95% BCI: 21%-66%) and control (6%, 95% BCI: 1%-11%). Strength of evidence (SOE) was high for propranolol's effects on reducing lesion size compared with observation/placebo. Corticosteroids demonstrated moderate effectiveness at reducing size/volume (moderate SOE for improvement in IH). SOE was low for effects of topical timolol versus placebo. LIMITATIONS: Methodologic limitations of available evidence may compromise SOE. Validity of meta-analytic estimates relies on the assumption of exchangeability among studies, conditional on effects of the intervention. Results rely on assumed lack of reporting bias. CONCLUSIONS: Propranolol is effective at reducing IH size compared with placebo, observation, and other treatments including steroids in most studies. Corticosteroids demonstrate moderate effectiveness at reducing IH size/volume. The meta-analysis estimates provide a relative ranking of anticipated rates of lesion clearance among treatments. Families and clinicians making treatment decisions should also factor in elements such as lesion size, location, number, and type, and patient and family preferences.

Implementing Family-Centered Cesarean Birth.

Cesarean birth is recognized as a physical and psychological stressor for many women. Maternity practices during cesarean birth should meet women's needs, while maintaining safety, to optimize the experience. Family-centered cesarean birth is a package of interventions that encourages a woman to participate in choosing interventions that would be helpful when undergoing a planned or unplanned cesarean birth. Included in family-centered cesarean birth is implementation of skin-to-skin care in the operating room for neonates who appear term and healthy. The process of attempting to implement family-centered cesarean birth at one academic center is presented, including steps for implementation, benefits, challenges, and areas for continued improvement and research. This article is part of a special series of articles that address midwifery innovations in clinical practice, education, interprofessional collaboration, health policy, and global health.

Treatment of ankyloglossia for reasons other than breastfeeding: a systematic review.

BACKGROUND AND OBJECTIVE: Children with ankyloglossia, an abnormally short, thickened, or tight lingual frenulum, may have restricted tongue mobility and sequelae, such as speech and feeding difficulties and social concerns. We systematically reviewed literature on feeding, speech, and social outcomes of treatments for infants and children with ankyloglossia. METHODS: Medline, PsycINFO, Cumulative Index of Nursing and Allied Health Literature, and Embase were searched. Two reviewers independently assessed studies against predetermined inclusion/exclusion criteria. Two investigators independently extracted data on study populations, interventions, and outcomes and assessed study quality. RESULTS: Two randomized controlled trials, 2 cohort studies, and 11 case series assessed the effects of frenotomy on feeding, speech, and social outcomes. Bottle feeding and social concerns, such as ability to use the tongue to eat ice cream and clean the mouth, improved more in treatment groups in comparative studies. Supplementary bottle feedings decreased over time in case series. Two cohort studies reported improvement in articulation and intelligibility with treatment. Other benefits were unclear. One randomized controlled trial reported improved articulation after Z-frenuloplasty compared with horizontal-to-vertical frenuloplasty. Numerous noncomparative studies reported speech benefits posttreatment; however, studies primarily discussed modalities, with outcomes including safety or feasibility, rather than speech. We included English-language studies, and few studies addressed longer-term speech, social, or feeding outcomes; nonsurgical approaches, such as complementary and alternative medicine; and outcomes beyond infancy, when speech or social concerns may arise. CONCLUSIONS: Data are currently insufficient for assessing the effects of frenotomy on nonbreastfeeding outcomes that may be associated with ankyloglossia.

Rise in late onset vitamin K deficiency bleeding in young infants because of omission or refusal of prophylaxis at birth.

BACKGROUND: Newborns are at risk for vitamin K deficiency and subsequent bleeding unless supplemented at birth. Vitamin K deficiency bleeding is an acquired coagulopathy in newborn infants because of accumulation of inactive vitamin K-dependent coagulation factors, which leads to an increased bleeding tendency. Supplementation of vitamin K at birth has been recommended in the United States since 1961 and successfully reduced the risk of major bleeding. Refusal or omission of vitamin K prophylaxis is increasing and puts newborn infants at risk for life-threatening bleeding. PATIENTS: Over an eight month period, we encountered seven infants with confirmed vitamin K deficiency; five of these patients developed vitamin K deficiency bleeding. RESULTS: The mean age of the seven infants with vitamin K deficiency was 10.3 weeks (range, 7-20 weeks); manifestations ranged from overt bleeding to vomiting, poor feeding, and lethargy. None of the infants had received vitamin K at birth, and all were found to have profound derangement of coagulation parameters, which corrected rapidly with administration of vitamin K in IV or intramuscular form. Four of the seven infants had intracranial hemorrhage; two of these infants required urgent neurosurgical intervention. CONCLUSION: Supplementation of vitamin K at birth for all newborns prevents major hemorrhagic complications, such as intracranial bleeding, due to vitamin K deficiency. Parental refusal of vitamin K is increasingly common. It is critical that health care providers and the public be made aware of the varied presentation of this preventable acquired coagulopathy.