Decreasing birth asphyxia: utility of statistical process control in a low-resource setting.

The neonatal period is a critical time for survival of the child. A disproportionate amount of neonatal deaths occur in low-resource countries and are attributable to perinatal events, especially birth asphyxia. This project aimed to reduce the incidence of birth asphyxia by 20% by June 2014 through training in neonatal resuscitation and improving the availability of resuscitation equipment in the delivery room in the National Hospital Abuja, Nigeria. A prospective, longitudinal study using statistical process control analytical methods was done enrolling babies delivered at the National Hospital Abuja. Low Apgar scores or birth asphyxia (defined a priori as any score <7 at 1, 5 and/or at 10 min) was assessed. To ensure reliability and validity of Apgar scoring, trainings on scoring were held for labour and delivery staff. Interventions included provision of additional equipment and trainings on neonatal resuscitation. Apgar scores were aggregated weekly over 25 months. Control charts with three SE confidence limits were used to monitor the proportion of scores ≤7. The baseline incidence of low Apgar scores, as defined a priori, was 33%, 17% and 10% while postintervention the incidence was 18%, 17% and 6% at 1, 5 and 10 min, respectively-a reduction of 45% and 40% in the 1-min and 10-min low Apgar scores. Increased communication, additional resuscitation equipment and training of delivery personnel on neonatal resuscitation are associated with reductions in measures of birth asphyxia. These improvements have been sustained and efforts are ongoing to spread our interventions to other special care delivery units/nursery in adjoining states. Our study demonstrates the feasibility and utility of using improvement science methods to assess and improve perinatal outcome in low-resource settings.

State-based perinatal quality collaboratives: Pursuing improvements in perinatal health outcomes for all mothers and newborns.

State-based perinatal quality collaboratives (SPQC) have become increasingly widespread in the United States. Whereas the first was launched in 1997, today over 40 states have SPQCs that are actively working or are in development. Despite great variability in the structure and function of SPQCs among states, many have seen their efforts lead to significant improvements in the care of mothers and newborns. Clinical topics targeted by SPQCs have included nosocomial infection in newborns, human milk use, neonatal abstinence syndrome, early term deliveries without a medical indication, maternal hemorrhage, and maternal hypertension, among others. While each SPQC uses approaches suited to its own context, several themes are common to the goals of all SPQCs, including developing obstetric and neonatal partnerships; including families as partners; striving for participation by all providers; utilizing rigorous quality improvement science; maintaining close partnerships with public health departments; and seeking population-level improvements in health outcomes.

The investment case for preventing NICU-associated infections.

BACKGROUND: Nosocomial [hospital-associated or neonatal intensive care unit (NICU)-associated] infections occur in as many as 10 to 36% of very low-birth-weight infants cared for in NICUs. OBJECTIVE: To determine the potentially avoidable, incremental costs of care associated with NICU-associated bloodstream infections. STUDY DESIGN: This retrospective study included all NICU admissions of infants weighing 401 to 1500 g at birth in the greater Cincinnati region from January 1, 2005, through December 31, 2007. Nonphysician costs of care were compared between infants who developed at least one bacterial bloodstream infection prior to NICU discharge or death and infants who did not. Costs were adjusted for clinical and demographic characteristics that are present in the first 3 days of life and are known associates of infection. RESULTS: Among 900 study infants with no congenital anomaly and no major surgery, 82 (9.1%) developed at least one bacterial bloodstream infection. On average, the cost of NICU care was $16,800 greater per infant who experienced NICU-associated bloodstream infection. CONCLUSION: Potentially avoidable costs of care associated with bloodstream infection can be used to justify investments in the reliable implementation of evidence-based interventions designed to prevent these infections.

Brain injury following trial of hypothermia for neonatal hypoxic-ischaemic encephalopathy.

OBJECTIVE: The objective of our study was to examine the relationship between brain injury and outcome following neonatal hypoxic-ischaemic encephalopathy treated with hypothermia. DESIGN AND PATIENTS: Neonatal MRI scans were evaluated in the National Institute of Child Health and Human Development (NICHD) randomised controlled trial of whole-body hypothermia and each infant was categorised based upon the pattern of brain injury on the MRI findings. Brain injury patterns were assessed as a marker of death or disability at 18-22 months of age. RESULTS: Scans were obtained on 136 of 208 trial participants (65%); 73 in the hypothermia and 63 in the control group. Normal scans were noted in 38 of 73 infants (52%) in the hypothermia group and 22 of 63 infants (35%) in the control group. Infants in the hypothermia group had fewer areas of infarction (12%) compared to infants in the control group (22%). Fifty-one of the 136 infants died or had moderate or severe disability at 18 months. The brain injury pattern correlated with outcome of death or disability and with disability among survivors. Each point increase in the severity of the pattern of brain injury was independently associated with a twofold increase in the odds of death or disability. CONCLUSIONS: Fewer areas of infarction and a trend towards more normal scans were noted in brain MRI following whole-body hypothermia. Presence of the NICHD pattern of brain injury is a marker of death or moderate or severe disability at 18-22 months following hypothermia for neonatal encephalopathy.

In their own words: adolescent views on ADHD and their evolving role managing medication.

OBJECTIVE: Up to 90% of adolescents with attention deficit hyperactivity disorder (ADHD) remain functionally impaired, yet less than half continue to take medication. The objective of this study was to gain a detailed understanding of how adolescents with ADHD contribute to medication treatment decisions. METHODS: Forty-four adolescents with ADHD aged 13 to 18 years old participated in 1 of 7 focus groups. An experienced facilitator used a semi-structured focus group guide to prompt discussion which was audio-recorded and transcribed verbatim. We coded transcripts using an inductive approach. Thematic saturation was reached after the seventh focus group. RESULTS: Adolescents assumed increased responsibility for managing medication as they matured and developed insight into the functional impact of ADHD and medication on their lives. Insights were often formed by contrasting time spent on and off medication. ADHD impacted functioning in the following domains: academics, social interactions and relationships, creativity, and driving skills. Select domains were relevant for some adolescents but not others. Adolescents described different roles that they played in managing medication as well as strategies they used to exert autonomy over medication use. Side effects were common and contributed to negative feelings toward medication. Some adolescents had begun to use medication selectively. Many expressed uncertainty about future use of medication. CONCLUSIONS: Adolescents assume an increasing role in managing medication for ADHD. Well-structured and coordinated trials stopping medication and measuring outcomes relevant to adolescents, parents, teachers, doctors, and/or other stakeholders may help ensure a developmentally appropriate transition from family to self-management of ADHD.

Using improvement science to increase accuracy and reliability of gestational age documentation.

Our aim was to improve the reliability of recording gestational age (GA) in the mother's obstetric record, as this record is used for clinical management, research databases, and eventual transmission to the Ohio Department of Health birth certificates. We performed a prospective cohort study, including all hospital births. We began quality improvement interventions in October 2009. Improvement test cycles were targeted to four working groups, including nursing staff, community obstetric providers, and the process itself. Test cycle results were evaluated to determine which successful interventions could spread further. Rates of process outcome measurements were compared by statistical process control and univariate analysis pre- and postintervention. During the preintervention period, the median daily GA reliability was 25%. To date, over 30 small sample size tests of change have been completed. Of 8795 births studied, significant improvement in GA accuracy/completeness was detected (median postintervention = 78%, p < 0.01). Increased communication of and completion of the prenatal record, in addition to GA recording in high-risk groups, such as premature infants, were also achieved (all p < 0.01). GA reliability can be increased using standardized improvement science methods. Better communication of GA will enable better clinical decisions and foster population-based perinatal research.

Spontaneous late preterm births: what can be done to improve outcomes?

Despite the increase in indicated late preterm births, spontaneous preterm labor and preterm premature rupture of the fetal membranes are the most common antecedent diagnoses leading to births between 34-0/7 and 36-6/7 weeks of gestation. Regional and institutional variation in the rates of late spontaneous preterm birth suggests that there may be opportunities to reduce the number of these births. This article summarizes the factors contributing to late spontaneous preterm birth and offers suggestions to improve care for these mothers and infants.

What we have here is a failure to communicate: obstacles to optimal care for preterm birth.

Obstetricians and pediatricians share the common goal of a healthy beginning for every baby, mother, and family. This article asserts that miscommunication between the specialties, fostered by separate definitions, metrics, and outcomes, is an impediment to optimal care. Solutions are suggested for improving communication and outcomes.

Cytokines and neurodevelopmental outcomes in extremely low birth weight infants.

OBJECTIVE: To determine if selected pro-inflammatory and anti-inflammatory cytokines and/or mediators of inflammation reported to be related to the development of cerebral palsy (CP) predict neurodevelopmental outcome in extremely low birth weight infants. STUDY DESIGN: Infants with birth weights ≤1000 g (n = 1067) had blood samples collected at birth and on days 3 ± 1, 7 ± 1, 14 ± 3, and 21 ± 3 to examine the association between cytokines and neurodevelopmental outcomes. The analyses were focused on 5 cytokines (interleukin [IL] 1ß; IL-8; tumor necrosis factor-α; regulated upon activation, normal T-cell expressed, and secreted (RANTES); and IL-2) reported to be most predictive of CP in term and late preterm infants. RESULTS: IL-8 was higher on days 0-4 and subsequently in infants who developed CP compared with infants who did not develop CP in both unadjusted and adjusted analyses. Other cytokines (IL-12, IL-17, tumor necrosis factor-ß, soluble IL rα, macrophage inflammatory protein 1ß) were found to be altered on days 0-4 in infants who developed CP. CONCLUSIONS: CP in former preterm infants may, in part, have a late perinatal and/or early neonatal inflammatory origin.

Predictive value of an early amplitude integrated electroencephalogram and neurologic examination.

OBJECTIVE: To examine the predictive validity of the amplitude integrated electroencephalogram (aEEG) and stage of encephalopathy among infants with hypoxic-ischemic encephalopathy (HIE) eligible for therapeutic whole-body hypothermia. DESIGN: Neonates were eligible for this prospective study if moderate or severe HIE occurred at <6 hours and an aEEG was obtained at <9 hours of age. The primary outcome was death or moderate/severe disability at 18 months. RESULTS: There were 108 infants (71 with moderate HIE and 37 with severe HIE) enrolled in the study. aEEG findings were categorized as normal, with continuous normal voltage (n=12) or discontinuous normal voltage (n=12), or abnormal, with burst suppression (n=22), continuous low voltage (n=26), or flat tracing (n=36). At 18 months, 53 infants (49%) experienced death or disability. Severe HIE and an abnormal aEEG were related to the primary outcome with univariate analysis, whereas severe HIE alone was predictive of outcome with multivariate analysis. Addition of aEEG pattern to HIE stage did not add to the predictive value of the model; the area under the curve changed from 0.72 to 0.75 (P=.19). CONCLUSIONS: The aEEG background pattern did not significantly enhance the value of the stage of encephalopathy at study entry in predicting death and disability among infants with HIE.

Ohio statewide quality-improvement collaborative to reduce late-onset sepsis in preterm infants.

OBJECTIVE: We aimed to reduce late-onset bacterial infections in infants born at 22 to 29 weeks' gestation by using collaborative quality-improvement methods to implement evidence-based catheter care. We hypothesized that these methods would result in a 50% reduction in nosocomial infection. PATIENTS AND METHODS: We conducted an interrupted time-series study among 24 Ohio NICUs. The intervention began in September 2008 and continued through December 2009. Sites used the Institute for Healthcare Improvement Breakthrough Series quality-improvement model to facilitate implementation of evidence-based catheter care. Data were collected monthly for all catheter insertions and for at least 10 observations of indwelling catheter care. NICUs also submitted monthly data on catheter-days, patient-days, and episodes of infection. Data were analyzed by using statistical process control methods. RESULTS: During the intervention, NICUs submitted information on 1916 infants. Of the 242 infections reported, 69% were catheter associated. Compliance with catheter-insertion components was >90% by April 2009. Compliance with components of evidence-based indwelling catheter care reached 80.4% by December 2009. There was a significant reduction in the proportion of infants with at least 1 late-onset infection from a baseline of 18.2% to 14.3%. CONCLUSIONS: There was a 20% reduction in the incidence of late-onset infection after the intervention, but the magnitude was less than hypothesized, perhaps because compliance with components of evidence-based care of indwelling catheters remained <90%. Because nearly one-third of infections were not catheter associated, improvement may require attention to other aspects of care such as skin integrity and nutrition.

Clinical seizures in neonatal hypoxic-ischemic encephalopathy have no independent impact on neurodevelopmental outcome: secondary analyses of data from the neonatal research network hypothermia trial.

It remains controversial as to whether neonatal seizures have additional direct effects on the developing brain separate from the severity of the underlying encephalopathy. Using data collected from infants diagnosed with hypoxic-ischemic encephalopathy, and who were enrolled in an National Institute of Child Health and Human Development trial of hypothermia, we analyzed associations between neonatal clinical seizures and outcomes at 18 months of age. Of the 208 infants enrolled, 102 received whole body hypothermia and 106 were controls. Clinical seizures were generally noted during the first 4 days of life and rarely afterward. When adjustment was made for study treatment and severity of encephalopathy, seizures were not associated with death, or moderate or severe disability, or lower Bayley Mental Development Index scores at 18 months of life. Among infants diagnosed with hypoxic-ischemic encephalopathy, the mortality and morbidity often attributed to neonatal seizures can be better explained by the underlying severity of encephalopathy.

Understanding variation in vitamin A supplementation among NICUs.

OBJECTIVE: We examined and characterized variation among NICUs in the use of vitamin A supplementation for the prevention of bronchopulmonary dysplasia in extremely low birth weight infants. METHODS: An historical cohort study of extremely low birth weight infants admitted within 7 days after birth to NICUs participating in the Pediatric Health Information System database, between January 1, 2005, and March 31, 2008, was performed. NICU medical directors were surveyed to determine attitudes and decision-making regarding adoption of vitamin A supplementation. The proportion of infants receiving vitamin A at each center was measured over time. Patient and hospital characteristics associated with vitamin A use were examined. RESULTS: Among 4184 eligible infants cared for in 30 NICUs, 1005 infants (24%) received vitamin A. Eighteen centers (60%) used vitamin A for some patients. Infants discharged in 2007 (odds ratio: 2.7 [95% confidence interval: 1.4-5.3]) and 2008 (odds ratio: 2.8 [95% confidence interval: 1.4-5.8]), compared with 2005, were more likely to receive vitamin A. NICU medical directors from centers using vitamin A, compared with centers that did not adopt vitamin A supplementation, reported stronger beliefs in the efficacy of vitamin A to reduce the incidence of bronchopulmonary dysplasia (83% vs 33%; P = .03) and in the ease with which vitamin A could be implemented (75% vs 22%; P = .02). CONCLUSIONS: Although the use of vitamin A is increasing, marked variation across NICUs remains. Provider attitudes and system characteristics seem to influence vitamin A adoption.

Early CPAP versus surfactant in extremely preterm infants.

BACKGROUND: There are limited data to inform the choice between early treatment with continuous positive airway pressure (CPAP) and early surfactant treatment as the initial support for extremely-low-birth-weight infants. METHODS: We performed a randomized, multicenter trial, with a 2-by-2 factorial design, involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. Infants were randomly assigned to intubation and surfactant treatment (within 1 hour after birth) or to CPAP treatment initiated in the delivery room, with subsequent use of a protocol-driven limited ventilation strategy. Infants were also randomly assigned to one of two target ranges of oxygen saturation. The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks (with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30% oxygen). RESULTS: A total of 1316 infants were enrolled in the study. The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group (47.8% and 51.0%, respectively; relative risk with CPAP, 0.95; 95% confidence interval [CI], 0.85 to 1.05) after adjustment for gestational age, center, and familial clustering. The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks (rates of primary outcome, 48.7% and 54.1%, respectively; relative risk with CPAP, 0.91; 95% CI, 0.83 to 1.01). Infants who received CPAP treatment, as compared with infants who received surfactant treatment, less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia (P<0.001), required fewer days of mechanical ventilation (P=0.03), and were more likely to be alive and free from the need for mechanical ventilation by day 7 (P=0.01). The rates of other adverse neonatal outcomes did not differ significantly between the two groups. CONCLUSIONS: The results of this study support consideration of CPAP as an alternative to intubation and surfactant in preterm infants. (ClinicalTrials.gov number, NCT00233324.)

Infant death among Ohio resident infants born at 32 to 41 weeks of gestation.

OBJECTIVE: The aim of this study was to determine gestational age-specific, adjusted infant mortality rates for Ohio. STUDY DESIGN: Using a retrospective cohort design, all births and infant deaths from 2003-2005 were included in multivariable regression analyses. Variations in cause and timing of infant death were determined. RESULTS: Compared with births at 39 or 40 weeks, adjusted likelihood of infant death increased progressively between 38-32 weeks' gestational age. At later gestational ages, death was more likely caused by sudden infant death syndrome or intentional injury compared with congenital malformations and asphyxia or cerebral palsy at earlier gestational ages. Less mature infants tended to die earlier. CONCLUSION: The current study confirms for Ohio and extends the findings of others that infant mortality risk is increased for births at late preterm and near-term gestational ages. Decisions to deliver before 39 weeks should consider increased likelihood of infant death that may be unrelated to fetal malformations or maternal illness.

A statewide initiative to reduce inappropriate scheduled births at 36(0/7)-38(6/7) weeks' gestation.

OBJECTIVE: We sought to reduce scheduled births between 36(0/7)-38(6/7) weeks that lack appropriate medical indication. STUDY DESIGN: Twenty Ohio maternity hospitals collected baseline data for 60 days and then selected locally appropriate Institute for Healthcare Improvement Breakthrough Series interventions to reduce the incidence of scheduled births. Deidentified birth data were analyzed centrally. Rates of scheduled births without a documented indication, birth certificate data, and implementation issues were shared regularly among sites. RESULTS: The rate of scheduled births between 36(0/7)-38(6/7) weeks without a documented medical indication declined from 25% to <5% (P < .05) in participating hospitals. Birth certificate data showed inductions without an indication declined from a mean of 13% to 8% (P < .0027). Dating criteria were documented in 99% of charts. CONCLUSION: A statewide quality collaborative was associated with fewer scheduled births lacking a documented medical indication.

Risk analysis and an alternative protocol for reduction of screening for retinopathy of prematurity.

PURPOSE: To determine whether a multivariate risk model can select infants with low-risk eyes for an alternative protocol that reduces retinopathy of prematurity (ROP) screening without loss of effectiveness. METHODS: This was a retrospective, nonrandomized, comparative study. We assigned 712 eyes of 357 premature infants of 401-1,250 g birth weights as high or low risk for prethreshold or threshold ROP using a risk model with variables of birth weight, gestational age, multiple birth, race, and gender. Using simulations, infants with high-risk eyes (p > or = 0.15) were screened conventionally, while those with low-risk eyes were screened with the 35q3 protocol (initial examination at 35 weeks postmenstrual age followed by screening every 3 weeks, with increased or decreased intervals based on ROP severity). The resultant reduction in ROP screening and the delay to detection of severe ROP were calculated. RESULTS: The 35q3 protocol reduced the mean number of eye examinations per infant in the overall population by 13.4% (p = 0.0051). No eyes had a delay to the detection of threshold or type 1 zone 1 ROP. Of a total of 57 type 1 ROP eyes, 2 eyes with type 1 zone 2 ROP were delayed to detection by 1 week. As our study was done prior to the Early Treatment of ROP study, the 2 eyes were observed and regressed without progression to threshold ROP. CONCLUSIONS: A risk-based alternative screening protocol increased the efficiency of ROP screening for infants of 401-1,250 g birth weight without an apparent loss of effectiveness. This investigational approach requires further validation by multicenter studies.

Parental angst making and revisiting decisions about treatment of attention-deficit/hyperactivity disorder.

BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurobehavioral conditions of childhood and adolescence. Despite availability of effective treatment options, initiation of treatment is variable and persistence with therapeutic regimens is poor. OBJECTIVE: We sought to better understand how parents make decisions about treatment for their child or adolescent with ADHD. METHODS: We conducted a qualitative study among parents of children and adolescents; 52 parents participated in 1 of 12 focus groups. Parents answered questions about decision-making, information sharing, and sources of conflict and uncertainty. Sessions were audiotaped and transcribed verbatim. Themes were coded independently by 4 of the investigators, who then agreed on common themes. RESULTS: Parents in our study made decisions about treatment for their child with ADHD in the midst of experiencing a variety of emotions as they witnessed child functional impairments at home and at school. In addition, parents felt stress as a result of their daily efforts to manage their child's struggles. Multiple factors influenced the decision to initiate medication. Subsequently, revisiting the decision to give their child medicine for ADHD was common. Many parents contrasted time on and off medicine to help inform management decisions. Trials stopping medication were almost always parent- or child-initiated. CONCLUSIONS: Decisions about medication use for children and adolescents with ADHD are made and frequently revisited by their parents. Choices are often made under stressful conditions and influenced by a variety of factors. Striking a balance between benefits and concerns is an ongoing process that is often informed by contrasting time on and off medication. Development of strategies to support families across the continuum of decisions faced while managing ADHD is warranted.

Epidemiology of necrotizing enterocolitis temporal clustering in two neonatology practices.

OBJECTIVE: To develop a statistical method for defining clusters of necrotizing enterocolitis (NEC) cases in the neonatal intensive care unit (NICU). STUDY DESIGN: The study group included 2782 infants weighing 401 to 1500 g at birth born between 1996 and 2004. NEC was defined as Bell stage II or III. Two statistical methods were used to define "disease clusters": a modified scan test and a comparison of observed and expected incidence density rates (IDRs) of NEC at each NICU. RESULTS: The proportion of infants with NEC was similar in the 2 NICUs (7.1% vs 7.7%; P = .6), as was the expected IDR of NEC (1.39/1000 patient-days vs 1.32/1000 patient-days; P = .72). Twelve temporal clusters of NEC were identified in the 2 NICUs, representing 18% of 203 total NEC cases during the study period. No seasonal/secular trends were noted for NEC rates or identified clusters. Potential NEC clusters of > or =3 cases at either NICU had a >75% likelihood of being a true NEC cluster. CONCLUSIONS: No operational definition of NEC cluster exists. This study introduces methods to use in prospective surveillance and to guide studies investigating etiologic relevance. Using the proposed methods, statistically significant clusters (ie, potential outbreaks) of NEC within NICUs can be identified early, providing an opportunity for early implementation of cluster investigation protocols.

Use of a body proportionality index for growth assessment of preterm infants.

OBJECTIVE: To evaluate the utility of weight-for-length (defined as gm/cm(3), known as the "ponderal index") as a complementary measure of growth in infants in neonatal intensive care units (NICUs). STUDY DESIGN: This was a secondary analysis of infants (n=1214) of gestational age 26 to 29 weeks at birth, included in a registry database (1991-2003), who had growth data at birth and discharge. Weight-for-age and weight-for-length were categorized as small (<10th percentile), appropriate, or large (>90th percentile). RESULTS: Statistical agreement between the weight-for-age and weight-for-length measures was poor (kappa=0.02 at birth, 0.10 at discharge; Bowker test for symmetry, P< .0001). From birth to discharge, the percentage of small-for-age infants increased from 12% to 21%, the percentage of small-for-length infants decreased from 10% to 4%, the percentage of large-for-age infants remained similar (<1%), and the percentage of large-for-length infants increased from 5% to 17%. At discharge, 92% of the small-for-age infants were appropriate or large-for-length, and 19% of the appropriate-for-age infants were large-for-length. CONCLUSIONS: Weight-for-age and weight-for-length are complementary measures. Weight-for-length or other measures of body proportionality should be considered for inclusion in routine growth monitoring of infants in the NICU.