INTERVENTION AND PERIVIABLE BIRTH
Many issues concerning the care of “periviable” infants remain unresolved. When faced with a woman in labor earlier than 24 weeks' gestation, questions can arise about what interventions (transfer, tocolysis, antenatal corticosteroids, antibiotics, electronic fetal monitoring, cesarean delivery) should be offered. Decisions must be made about initial resuscitation and continuing intensive care, should the periviable neonate survive.
In 2013, the Society for Maternal-Fetal Medicine, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the Section on Perinatal Pediatrics of the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists convened a joint workshop to consider the many issues surrounding the birth of periviable infants. The workshop's report1 summarizes the benefits and risks of obstetric and neonatal interventions related to periviable birth, provides an outline for counseling parents, describes newborn infant outcomes after periviable birth, and outlines research and educational agendas for the care and treatment of these patients. Recommendations for treatment made by this expert panel were drawn from the available literature and by extrapolating from relevant studies.
The “periviable period” is defined as delivery occurring from 20 weeks through 25 weeks and 6 days of gestation. For each of 3 gestational age categories, less than 22 weeks, 22 weeks and 1 day to 22 weeks and 6 days, and 23 weeks or more, recommendations are made for the use or nonuse of interventions, including corticosteroids, tocolytics, magnesium sulfate for neuroprotection, antibiotics for group B streptococcus prophylaxis or for premature rupture of membranes, electronic fetal monitoring, cesarean delivery, and aggressive neonatal resuscitation. In general, few peripartum interventions are recommended for consideration before the 23 weeks' mark, after which infants should be considered potentially viable. Aggressive neonatal resuscitation is not recommended before 22 weeks (only palliative care should be provided), or between 22 and 22 weeks and 6 days unless the fetus is potentially viable, but is recommended after 23 weeks (unless the fetus is nonviable).
If a decision is made to pursue neonatal resuscitation, the periviable neonate's extreme immaturity and small size necessitate special considerations, such as enhancing placental transfusion by delaying cord clamping for up to 30 seconds, taking steps to prevent hypothermia, having the most experienced and skilled caregiver perform the intubation, and avoiding the need for chest compressions, if possible, by establishing effective ventilation. The report also details special considerations for the “golden hours” immediately following resuscitation, and the challenges of managing periviable infants into the first week of life. The report places a strong emphasis on counseling the parents in the case of a threatened periviable birth. Such counseling should be evidence-based, bidirectional, collaborative, and ongoing, according to the information needs of the parents and the evolving clinical situation.
1. Raju TN, Mercer BM, Burchfield DJ, Joseph GF. Periviable birth: executive summary of a joint workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, American Academy of Pediatrics, and American College of Obstetricians and Gynecologists. Obstet Gynecol. 2014;123:1083–1096.
ASSISTED REPRODUCTIVE TECHNOLOGIES: FILLING OUR NEONATAL INTENSIVE CARE UNITS
The National Perinatal Association (NPA) recently called on reproductive endocrinologists and health insurance companies to reduce the health risks associated with in vitro fertilization procedures by increasing the use of the safer elective single embryo transfer technique, which is recommended by the American Society for Reproductive Medicine. In a position statement, “Ethical Use of Assisted Reproductive Technologies,”1 the NPA also stresses the need for more transparent and multidisciplinary patient education, counseling, and informed consent about the potential consequences of assisted reproductive technology (ART) and multiple birth pregnancies, which can pose serious health, emotional, and financial risks to families.
This position statement was prompted by the growing number of multiple births that result from ART pregnancies, far outnumbering the number of multiple births that occur naturally. The latest Centers for Disease Control and Prevention ART surveillance report reveals that of 61,564 babies born through ART in 2009, 46.4% were twins, triplets, or higher-order multiples. This contrasts with 3% of naturally conceived infants who are multiples.2
The NPA's position statement emphasizes that multiples born through ART often require lengthy neonatal intensive care unit (NICU) stays and have significant health sequelae. A recent study3 of ART and artificial insemination (AI) births in California supports this claim. Researchers analyzed the occurrence of prematurity, low birth weight, multiple gestations, stillbirths, and other care and outcome variables in women who conceived through ART/AI compared with women who conceived naturally, from 2009 to 2011. Among ART/AI pregnancies, there was a 4.5-fold increase in stillbirths, a 4-fold increase in cesarean sections, and a 4-fold increase in preterm birth. The rate of multiple gestations following ART/AI was 24 to 27 times higher compared with naturally conceived pregnancies. Maternal hospital stay and hospital charges were higher for women who conceived through ART/AI, as were infant hospital charges, whether the ART/AI pregnancy resulted in a singleton, twin, or triplet birth. A higher rate of fetal anomalies was found after ART/AI. The researchers concluded that families who seek ART/AI should be informed about the adverse pregnancy and neonatal outcomes and higher costs associated with ART/AI birth.
1. Merritt TA, Philips R, Goldstein M, Hoppe B. National Perinatal Association Position Statement—ethical use of assisted reproductive technologies: a call for greater transparency, better counseling of prospective parents and single embryo transfer to improve outcomes for mothers and babies. Neonatol Today. 2014;9:2–14.
2. Sunderam S, Kissin DM, Flowers L, et al. Centers for Disease Control and Prevention. Assisted reproductive technology surveillance—United States, 2009. MMWR Surveill Summ. 2012;61:1–23.
3. Merritt TA, Goldstein M, Philips R, et al. Impact of ART on pregnancies in California: an analysis of maternity outcomes and insights into the added burden of neonatal intensive care. J Perinatol. 2014;34:345–350.
THERAPEUTIC HYPOTHERMIA: STATE OF THE ART
Therapeutic hypothermia is a neuronal rescue strategy used in neonates with hypoxic-ischemic encephalopathy (HIE) with the aim of improving neurodevelopmental outcomes. Cooling (as it is commonly called) is an evolving intervention. It is typically applied according to the parameters tested in randomized trials, and as more data become available, these parameters may change.
Recently, a workgroup was convened to assess the current state of the evidence about therapeutic hypothermia, identify gaps in knowledge, and provide a framework for the implementation of hypothermia in neonates with HIE. According to the report published by this group,1 hypothermia should be implemented in medical centers that are capable of providing comprehensive clinical care, including mechanical ventilation; physiologic (vital signs, temperature) and biochemical (blood gas) monitoring; neuroimaging (including MRI); seizure detection and monitoring with amplitude-integrated electroencephalography (aEEG) or electroencephalography (EEG); neurologic consultation; and a system for monitoring longitudinal neurodevelopmental outcome.
Infants who undergo hypothermia should meet inclusion criteria (a pH of ≤7.0 or a base deficit of ≥16 mmol/L in an umbilical cord sample or blood obtained during the first hour after birth), history of an acute perinatal event, a 10-minute Apgar score of less than 5, or assisted ventilation initiated at birth and continued for at least 10 minutes. A neurologic examination should indicate moderate to severe encephalopathy. If preferential head cooling is used, abnormal background activity on either EEG or aEEG also is required.
The report emphasizes that training programs and infrastructure need to be established and maintained in a highly organized and reproducible manner to ensure patient safety. Centers offering hypothermia should have written protocols and monitor management and outcomes. Outreach education is an essential component to ensure the timely identification of infants at risk for HIE and the prevention of extreme hypothermia and hyperthermia.
Cooling of infants born at less than 35 weeks' gestation, those with mild HIE, and cooling for longer than 72 hours or at temperatures other than those used in clinical trials should not take place outside of research settings.
Whether cooling should be initiated at a community hospital or on transport was not definitively addressed by this report. Although research on cooling on transport or before admission to the center offering therapeutic hypothermia was described in the report, this issue is considered as an area of uncertainty at this time.
1. American Academy of Pediatrics. Committee on Fetus and Newborn. Hypothermia and neonatal encephalopathy. Pediatrics. 2014;133(6):1146–1150.
SNAPSHOT OF THE NURSE PRACTITIONER WORKFORCE
In 2012, a survey of nurse practitioners1 (NPs) was conducted by the US Health Resources Service Administration to provide the latest nationally representative estimates of the supply of NPs in the United States and to collect detailed data on the licensure, education, clinical practice characteristics, and demographics of NPs. The survey was sent to a random sample of 22,000 licensed NPs, representing every state and the District of Columbia. The response rate was 60.1%.
In 2012, there were an estimated 154,000 licensed NPs in the United States. Of these, more than 132,000 worked in a position requiring an NP credential, making up the current NP workforce. Within the NP workforce, 127,000 NPs were providing patient care, and nearly half of them (60,407) were working in primary care settings. Of the 22,000 licensed NPs who were not working in an NP position at the time of the survey, approximately 11,000 were working as registered nurses.
Most (94%) of the NP workforce held a graduate degree (86% master's in nursing, 5% doctoral degree, and 3% a nonnursing graduate degree). Nearly all of the NP workforce (96%) have held formal certification from a national certifying organization at some point in their careers. The most widely held certification is family NP, reported by almost half of the NP workforce.
Many older NPs are still in practice. The average age of NPs in 2012 was 48 years. The largest-age cohort of NPs, 55- to 59-year-olds, represented nearly 18% of the total NP workforce, and those 60 years of age and older represented 16%. Only 7% of NPs were male.
Almost all of the NP workforce were in clinical practice (96%) providing direct patient care. Nonclinical roles included faculty (3%) and administration (1%). Nurse practitioners working in patient care provide various services, from patient education to medical procedures.
More than 75% of NPs reported providing counseling and educating patients; conducting physical examinations and obtaining medical histories; prescribing drugs; and ordering, performing, and interpreting diagnostic studies. Fewer NPs reported performing procedures and making referrals.
By far, the most common specialty of practice for NPs was primary care. Neonatal care was reported as the practice setting of 3% of respondents. Nurse practitioners providing patient care reported various collaborative arrangements with physicians, depending on state laws and the nature of the NP's role. About 11% worked in a setting without a physician on site, but more than half reported working in a setting with a physician most of the time. Nurse practitioners who worked in hospitals reported the most physician presence.
Most of NPs (95%) who provide patient care had a National Provider Identifier number, although not all report using their National Provider Identifier for billing. Salaries of NPs varied substantially depending on role, setting, and specialty. Nurse practitioners in patient care reported earning a median of $87,500 annually in 2012. Those in surgical specialties earned the highest salaries (median $100,000), and primary care NPs earned the lowest (median $82,000). Nurse practitioners in faculty roles reported earning a median salary of $80,000 in 2012.
In general, NPs reported high levels of job satisfaction. Overall, 92% of NPs were “satisfied” or “very satisfied” with their position. When specific elements of the job were examined, NPs were most satisfied with their level of autonomy, time spent in patient care, sense of value for what they do, and respect from physician colleagues and other colleagues. Nurse practitioners were least satisfied with the amount of paperwork required, administrative support, and input into organizational or practice policies.
Nurse practitioners in the workforce were generally satisfied that their duties reflected the full scope of their NP capabilities and allowable scope of practice. Of those whose main position involves direct patient care, almost 84% agreed that they “practice to the fullest extent of the state's legal scope of practice,” and 89% agreed that their “NP skills are fully utilized.”
US Department of Health and Human Services. Health Resources and Services Administration Bureau of Health Professions National Center for Health Workforce Analysis Highlights From the 2012 National Sample Survey of Nurse Practitioners. Rockville, MD: US Department of Health and Human Services; 2014.
MISUSE OF VIALS
The Joint Commission wants healthcare providers to stop reusing single-dose injectable drug vials.1 At least 49 outbreaks of infections have occurred among recipients of injectable drugs taken from vials that were intended for single-use only. Single-use vials typically do not contain any preservatives and can easily become contaminated. Entering these vials more than once, regardless of technique or whether it is for the same or a different patient, poses a high risk for infection.
The misuse of vials has occurred in both inpatient and outpatient settings. Some healthcare providers compromise safe infection-control practices in attempts to prevent waste, to conserve the supply of drugs during medication shortages, or to reduce costs. However, any cost savings so achieved can quickly be offset by the adverse clinical outcomes associated with unsafe injection practices. Injectable vial misuse has transmitted blood-borne pathogens and bacteria, causing infections in thousands of patients, including hepatitis B, hepatitis C, meningitis, and epidural abscesses. Some patients died from these infections, and many others required prolonged or life-long treatment. Patients with underlying health conditions are at even greater risk for harm. The adverse outcomes of unsafe injection practices have significant legal and financial ramifications as well.
Appropriate use of single-dose/single-use injectable drug vials includes the following:
- Use single-dose/single-use vials only for a single patient during the course of a single procedure. Discard the vial after this single use; used vials should never be returned to stock on clinical units, drug carts, anesthesia carts, etc.
- If a single-dose/single-use vial must be entered more than once during a single procedure for a single patient to achieve safe and accurate titration of drug dosage, use a new needle and a new syringe for each entry.
- Single-dose/single-use vials opened in less than ISO Class 5 air quality must be used within 1 hour, with any remaining contents discarded. Single-dose/single-use vials opened in ISO Class 5 air quality can be used up to 6 hours.
- Do not combine or pool leftover contents of single-dose/single-use vials. Do not store used single-dose/single-use vials for later use, regardless of the size of the vial.
Appropriate use of multiple-dose injectable drug vials includes the following:
- Only vials clearly labeled by the manufacturer for multiple dose use can be used more than once.
- Limit the use of a multiple-dose vial to only a single patient, whenever possible, to reduce the risk of contamination.
- When multiple-dose vials are used more than once, use a new needle and new syringe for each entry. Do not leave needles or other objects in vial entry diaphragms between uses, as this may contaminate the vial's contents.
- Disinfect the vial's rubber septum before piercing by wiping (and using friction) with an approved antiseptic. Allow the septum to dry before inserting a needle or other device into the vial.
- Once a multiple-dose vial is punctured, it should be assigned a “beyond-use” date. The beyond-use date for an opened or entered (eg, needle-punctured) multiple-dose container with antimicrobial preservatives is 28 days, unless otherwise specified by the manufacturer.
All vials (single-dose/single-use and multiple-dose) should be discarded if sterility has been compromised or is questionable, including having been placed on a used procedure tray or used during an emergency procedure—even if the vial is unopened/unused. Select the smallest vial necessary when making purchasing and treatment decisions to reduce waste. Urge manufacturers to produce vials in appropriate sizes to reduce waste. In the NICU, it is difficult to find vial sizes that do not involve significant waste after the tiny dose needed has been extracted, but to protect our babies, we must learn to toss the vial.
The Joint Commission. Preventing infection from the misuse of vials. Sentinel Event Alert. June 16, 2014. http://www.jointcommission.org/assets/1/6/SEA_52.pdf. Accessed June 19, 2014.