A Systems Approach for Neonatal Hyperbilirubinemia in Term and Near-Term Newborns Vinod K. Bhutani, Lois H. Johnson, Ann Schwoebel, and Susan Gennaro

CLINICAL RESEARCH A Systems Approach for Neonatal Hyperbilirubinemia in Term and Near-Term Newborns Vinod K. Bhutani, Lois H. Johnson, Ann Schwoebel,...
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CLINICAL RESEARCH

A Systems Approach for Neonatal Hyperbilirubinemia in Term and Near-Term Newborns Vinod K. Bhutani, Lois H. Johnson, Ann Schwoebel, and Susan Gennaro

Objective: To propose and implement a familycentered systems approach to manage newborn jaundice for safer outcomes. Design: Observational study for known adverse outcomes. Setting: Semiprivate urban birthing hospital. Patients/Participants: 31,059 well babies discharged as healthy from a cohort of 41,961 live births (1990-2000). Interventions: Incremental implementation of a systems approach that incorporated a hospital policy to (a) authorize nurses to obtain a bilirubin (total serum/ transcutaneous) measurement for clinical jaundice, (b) universal predischarge total serum bilirubin (at routine metabolic screening), and (c) targeted follow-up, using the bilirubin nomogram (hour-specific, percentile-based total serum bilirubin/transcutaneous bilirubin). Main Outcome Measures: Known adverse outcomes assessed for early- and late-onset severe hyperbilirubinemia before, during, and after systems approach implementation. Results: Adverse outcomes decreased for well babies: exchange transfusion, intensive phototherapy, and readmission. During the study period, there were no “never events” (total serum bilirubin greater than or equal to 30 mg/dl), while “close calls” (total serum bilirubin greater than or equal to 25 mg/dl) were 1 in 15,000 as compared to a reported incidence of 1 in 625. Conclusions: Reduced adverse events, significant reduction in close calls, and no never events met family expectations for safer experiences with this approach. JOGNN, 35, 444-455; 2006. DOI: 10.1111/J.1552-6909.2006.00044.x Keywords: Kernicterus—Neonatal hyperbilirubinemia—Newborn jaundice—Patient safety— Systems approach 444 JOGNN

Accepted: August 2005

Acute bilirubin encephalopathy (ABE) (or acute kernicterus) resulting from newborn jaundice threatens the health and well-being of newborns and is again being reported in hospitals around the country (American Academy of Pediatrics [AAP] Update, 2001; Brown & Johnson, 1996; Joint Commission on Accreditation of Healthcare Organizations [JCAHO], 2001). In fact, the rise of kernicterus has led parents of infants diagnosed with kernicterus to band together in 2000 and form the Parents of Infants and Children with Kernicterus group (Sheridan, 2002). In reported cases of term and near-term newborns with kernicterus, the estimated incidence of kernicteric mortality is 5% and that of known posticteric sequelae among survivors is 88% (Bhutani & Johnson, 2004; Johnson, Bhutani, & Brown, 2002). The actual U.S. incidence of ABE is unknown because of limited diagnostic acumen for uncommon events and lack of a national reporting policy. Therefore, surrogate or proxy measures such as (a) incidences of a never event (total serum bilirubin [TSB] level greater than or equal to 30 mg/dl), (b) extreme hyperbilirubinemia (TSB levels greater than or equal to 25 mg/dl), (c) use of exchange transfusion, or (d) readmission of healthy term and near-term newborns for intensive phototherapy provide reasonable, useful alternative indices of known jaundice-related adverse experiences. Correlation of adverse neurologic outcomes to a specific TSB level is of value from a public health perspective for surveillance. However, because of the complex interaction of potentiating and protective factors that modulate bilirubin toxicity, there is no

© 2006, AWHONN, the Association of Women’s Health, Obstetric and Neonatal Nurses

specific threshold of hyperbilirubinemia that can distinguish a safe bilirubin level from an unsafe one. This has been a subject of significant debate (Bhutani, 2001; Maisels & Newman, 2001; Soorani-Lunsing, Woltil, & HaddersAlgra, 2001). Factors that modulate toxicity relate to host susceptibility and differences in albumin-bilirubin-binding affinity exceeding the binding capacity of available serum albumin (Poland, 2002). Potential risk of kernicteric mortality and preventable lifelong posticteric sequelae are nevertheless inextricably related to TSB levels. Infants with TSB levels greater than or equal to 20 mg/dl constitute a vulnerable group since the incidence of kernicterus is higher in this group of babies than in babies with TSB levels less than 20 mg/dl (Bhutani & Johnson, 2004). Even though many infants with TSB levels greater than 20 mg/ dl and less than 30 mg/dl may escape injury or, at least do not show overt neurologic abnormality, there are no prospective data that assure the neurologic well-being of such infants. When the AAP Practice Parameter for Management of Jaundice in the Term Newborn was published in 1994, Invited Commentaries for the Kinder, Gentler Approach by other bilirubin “experts” were also published in the same issue of Pediatrics (AAP, 1994). In several of these, concerns were raised that adoption of the new “consensusbased” recommendations without further scrutiny might lead to an increase in kernicterus and that no mechanism had been proposed to evaluate their safety and efficacy. Following multiple reports of the reemergence of kernicterus in the United States (Bhutani & Johnson, 2004; Brown & Johnson, 1996; MacDonald, 1995; Penn, Enzmann, Hahn, & Stevenson, 1994), both JCAHO Sentinel Alert (JCAHO, 2001) and an AAP report (AAP Update, 2001) suggested predischarge risk assessment by universal TSB screening or clinical risk factors scoring, to predict subsequent severe and extreme hyperbilirubinemia (Bhutani, Johnson, & Sivieri, 1999; Newman, Xiong, Gonzales, & Escobar, 2000; Stevenson et al., 2001). More recently, the subcommittee of the AAP (AAP Subcommittee on Hyperbilirubinemia, 2004) recommended systematic assessment before discharge of the risk of subsequent hyperbilirubinemia in order to target appropriate evaluation after discharge. The AAP now recommends either predischarge measurement of the bilirubin level using TSB or transcutaneous bilirubin (TcB) and/or assessment of clinical risk factors, or both. The purpose of this study was to examine the health outcomes related to an incremental institutional systems approach to manage neonatal hyperbilirubinemia. The fundamental components of this approach included the authority of nurses to obtain TSB/TcB at their discretion, universal TSB screening at routine metabolic screening, and targeted follow-up for those at risk for severe hyperbilirubinemia. This approach was incrementally implemented with the availability of an instrument to predict July/August 2006

risk for severe hyperbilirubinemia using the hour-specific bilirubin nomogram being developed and implemented for clinical practice during this study period.

Review of Literature Systems approach to predischarge management of newborn jaundice to prevent kernicterus relies on (a) visual recognition of jaundice, (b) measurement of bilirubin values, (c) lactation and nutrition support, and (d) parent education including the need for follow-up.

Visual Recognition of Jaundice The rise of kernicterus may be occurring in part because care providers are relying on their ability to visually recognize a jaundiced infant. With earlier discharge, infants may not be available to health care professionals when bilirubin peaks occur. Moreover, studies have demonstrated that visual recognition of jaundice is not a sensitive measure so even if health care professionals have access to infants, they tend to miss many infants who are vulnerable for kernicterus. In one study, between 20% and 40% of newborns with bilirubin levels between 6 and 8 mg/dl (levels thought to be visible to the trained eye) were not picked up by nurses and physicians (Tayaba, Gribetz, & Holzman, 1998). Other studies have demonstrated the constant underdetection of hyperbilirubinemia if visual recognition is the only method used in case finding (AAP Subcommittee on Hyperbilirubinemia, 2004; Ip et al., 2004). Visual recognition of jaundice is particularly inaccurate in babies with darker skin tones and in documenting the cephalo-caudal progression of jaundice in infants (Bhutani & Johnson, 2004; Johnson & Bhutani, 1998).

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ernicterus threatens healthy newborn infants because bilirubin usually peaks at age 3 to 5 days when the infant is at home.

In many institutions, nurses are not able to independently check for hyperbilirubinemia as a physician order to draw TSB levels or obtain a TcB is still required. Creating a system in which nurses have the independent authority to check for rising levels of bilirubin based on risk factors or clinical suspicion (as is routinely done for hypoglycemia) might result in better case finding for hyperbilirubinemia. The following correctable correlates of kernicterus have been documented by the AAP Update (2001): (a) early JOGNN 445

discharge less than 48 hours/with no early follow-up, (b) failure to check bilirubin level in an infant noted to be jaundiced in the first 24 hours of life, (c) failure to recognize the presence of risk factors for hyperbilirubinemia, (d) underestimating the severity of jaundice by visual assessment, (e) lack of concern regarding the presence of jaundice, (f) delay in measuring serum bilirubin levels despite marked jaundice or in initiating phototherapy in the presence of elevated bilirubin levels, and (g) failure to respond to parental concerns regarding jaundice such as poor feeding or lethargy. Each of these correctable factors is ameliorated with an aware nursing staff who is able to obtain TSB levels when necessary.

Measurement of Bilirubin Levels The only currently available clinical test that can be used to accurately predict the risk of subsequent severe hyperbilirubinemia is measurement of bilirubin plotted on an hour-specific nomogram (Figure 1) (Bhutani et al., 1999). The nomogram was constructed and evaluated in a study of 2,840 healthy infants with hour-specific TSB measurements prospectively measured before and after discharge. Among 6.1% of infants with TSB values in the high-risk zone (greater than 95th percentile) before

Check for Jaundice q 8 hours (record as vital sign)

Birth

None

Assess for clinical risk factors: 0.20 mg/dl TSB and >95th percentile for age in hours

None

Parental education, nutritional intake, assess and ensure feasibility and compliance with follow-up

Measure TSB /TcB for age in hours as soon as feasible

76th to 95th percentile

discharge, 39.5% remained in that zone after discharge. The incidence of postdischarge TSB level greater than 95th percentile is 4.4% in this closely monitored and prescreened population. The actual incidence is likely to be higher because of variations in practices for predischarge screening for hyperbilirubinemia, support for breastfeeding, or use of phototherapy. For the 61.8% of infants with predischarge TSB levels in the low-risk zone (less than 40th percentile), none developed bilirubin values in the high-risk zone. In addition, by expressing TSB values in terms of risk zones, rather than using an actual TSB value, the imprecision of TSB measurement is reduced. From a practical perspective, Bhutani et al. (1999) have recommended a minimum of one TSB/TcB before discharge regardless of absence of jaundice. A follow-up TSB/TcB is essential in all infants with predischarge values greater than 40th percentile at a timing based on the risk zones. For infants, with predischarge TSB/TcB values less than 40th percentile, routine follow-up is recommended at 3 to 5 days age including a clinical evaluation for jaundice and a bilirubin measurement at clinical discretion. Though developed for an urban Philadelphia community, the hourspecific bilirubin nomogram has been validated in several studies such that experts consider that sufficient data exist

76th to 95th percentile

Repeat TSB/TcB in 12 to 24 hours

Parental Education, provide instructions, arrange follow-up, and discharge

40th to 75th percentile

Repeat TSB /TcB in 48 hours

< 40th percentile

Re-evaluate clinically or TcB in 48 hours and continue routine care

FIGURE 1

Algorithm for a systems-based approach to manage newborns to prevent severe hyperbilirubinemia. TSB = total serum bilirubin; TcB = transcutaneous bilirubin.

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to alter clinical practice now (AAP Subcommittee on Hyperbilirubinemia, 2004).

Lactation Support Bilirubin metabolism is correlated with infant nutritional intake. Infants with inadequate nutritional intake are not able to clear the increased production of bilirubin that occurs in the transition to extrauterine life. Although in the past there has been concern about breastfeeding and breast milk jaundice adding to the difficulties in treating infants with hyperbilirubinemia, the AAP now recommends that breastfeeding should not be discontinued in healthy term infants with hyperbilirubinemia (AAP Update, 2001). However, the AAP does recommend frequent breastfeeding (at least 8-10 times in 24 hours). Further, lactation support has been demonstrated to significantly decrease problems with hyperbilirubinemia in breast-fed infants (Martin et al., 2002).

Parent Teaching and Postdischarge Follow-Up Parents receive contradictory information about the concern for newborn jaundice. Outpatient follow-up is dependent on parents understanding the small but real risk associated with hyperbilirubinemia. Parents must understand that “risk assessment strategies are needed to reliably identify infants who are at serious risk of harm, while minimizing the burden and potential labeling of infants who are well” (AAP Update, 2001, p. 763). Parents with infants with acute-stage kernicterus have documented interactions they have had with caregivers in which they were told that “most babies are jaundiced,” “it’s natural for babies to be sleepy,” and “don’t worry as long as the baby is feeding, wetting diapers, and stooling.” (Johnson et al., 2002). Helping both health care professionals and parents understand risk factors and cues for further surveillance is important given earlier hospital discharge of infants. A discharge protocol that assures appropriate bilirubin testing in high-risk infants is a key component of jaundice management.

Methods Study Population The study cohort was drawn from 41,961 live births at a large urban hospital from January 1, 1990, to December 31, 2000; 31,059 of these infants were discharged from the well baby nursery as term and near-term healthy newborns. This study period overlapped the concurrent study, which led to the development and report of the hour-specific bilirubin nomogram from 1993 to 1997 (Bhutani et al., 1999). The chronologic evolution of clinical approaches to manage newborn jaundice were (a) selective predischarge TSB measurements (1990-1992), (b) universal TSB measurement at time of routine metabolic screening and unfettered July/August 2006

nursing ability to measure TSB or TcB (1993-1995), (c) universal TSB screening and postdischarge follow-up as per the newly developed hour-specific bilirubin nomogram (1996-1998), and (d) an organized institutional systemsbased management of newborn jaundice (1999-2000). The continued impact of this program was assessed for the subsequent years, 2001 to 2003. The systems-based guidelines served as a framework rather than a rigid rule that allowed for individual physician practice variations. Well baby care was provided by more than 18 practicing pediatricians, several pediatric nurse practitioners, and home care nursing agencies. All babies were recommended for jaundice follow-up within 24 or 48 hours of discharge. The outcome of postdischarge TSB levels (done by visiting home nurses, at neighborhood local hospitals or laboratories) was tracked. A hospital-based program individually followed those babies not assured of a follow-up. The majority (greater than 85%) of care was provided by a hospital-based practice that primarily used hospital-based intensive phototherapy. Use of home phototherapy was limited to a few practitioners that cared for less than 15% of the discharged babies. All study cohort babies had predischarge TSB levels obtained at the same time as the routine metabolic screen. In some, earlier TSB values had been obtained because of visual recognition or suspicion of jaundice. Inclusion criteria for the data analysis was as follows: term or near-term infants. Term infants were defined as infants who were greater than or equal to 38 weeks gestation. Near-term infants were those less than 38 weeks gestation but had a birthweight (BW) of greater than or equal to 2000 g for 36 or more weeks gestation or BW greater than or equal to 2500 g for 35 or more weeks gestation. Exclusion criteria was as follows: Low BW preterm infants admitted to well baby nursery and any infant admitted to and treated in the intensive care nursery for neonatal illness were excluded because of potential confounding effects on newborn jaundice and these infants do not meet the strict definition of a “well baby.”

Investigations for Cause for Hyperbilirubinemia Additional investigations were done at physician discretion to determine the cause of hyperbilirubinemia. After 1998, routine testing for infant blood type and direct Coombs test were limited to those born to blood type O or Rh-negative mothers.

Visual Recognition of Jaundice Given the documented difficulties in accurately identifying jaundice through visual means alone, in 1998 nurse educators performed a didactic in-service education, skillassessment workshops, and participation in the development of a bilirubin care map. Factors associated with JOGNN 447

limitations of visual assessment of jaundice were reviewed, and nurses were authorized to obtain a TcB or a TSB measurement without a written physician order (as per institutional policy in 2000) for a suspicion or recognition of jaundice after admission to the well baby nursery. These institutional efforts led to the evolution of a systems approach.

Parent Teaching All parents counseled using jaundice instruction and information material prepared jointly by neonatologists and pediatric nurse practitioners (available upon request). This information focused on the benign nature of most newborn jaundice and informed parents of the potential but rare risk of bilirubin neurotoxicity if the progression of jaundice and hyperbilirubinemia were unmonitored or untreated.

Lactation Support An institution-wide program to support breastfeeding was initiated in 1990 but restructured in 1996. All breastfed babies were evaluated soon after birth and during hospitalization with a lactation attachment (latch) score as an objective instrument for bedside counseling. Mothers who gave birth by cesarean deliveries or by assisted vaginal deliveries, or those with lactation difficulties were supported in breast pumping. Mothers of infants with greater than or equal to 8% weight loss were provided individualized instruction to supplement feeds with expressed breast milk (or if necessary a breast milk substitute) and taught to monitor infant urine output and stooling patterns. By 1998, the lactation support services had established and implemented a systems approach to promote breastfeeding that included individualized counseling in hospital, a predischarge and postdischarge counseling program for at-risk infants, and guidelines to recommend, provide, and loan breast pump devices.

Postdischarge Follow-Up Planning for follow-up was facilitated by a Bilirubin Care Map (a tabular version of the hour-specific bilirubin nomogram for ages 41-72 hours) for nursing and physician use (Table 1). Overall management strategies are shown in the algorithm (Figure 2). Parents of infants discharged prior to 72 hours were instructed to see their own pediatricians, return to a hospital-based follow-up program, or have an insurance-authorized home visit within 24 or 48 hours based on infants’ predischarge TSB levels. Total serum bilirubin samples were obtained in the hospital outpatient laboratory or by the home care nurse and transported to the hospital laboratory for analysis. Mandatory physician/practitioner evaluation for jaundice or hyperbilirubinemia, or both, at about age 4 days (96 hours age, range: 84-108) regardless of discharge age was recommended. Concomitant evaluation for other newborn issues, such as nutrition, lactation support, hydration,

TABLE 1

Bilirubin Care Map for Discharge and Follow-up Based on Predischarge TSB level (mg/dl) a

Early Follow-Up (corresponds to 40th-90th percentile)

TSB Done at Hours of Age

Discharge Only if TSB Level is (corresponds to >95th percentile)

In 24 hr

41-44 45-48 49-56 57-64 65-72 Above 72

14.0< Repeat TSB and follow-up within 24 or 48 hr to document decline in TSB levels or need of intervention. Discharge if follow-up is assured

In 48 hr

Regular Follow-Up at Age 3-5 Days (corresponds to

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