Objective To determine the impact of policy changes for pulse oximetry oxygen saturation (SpO(2)) alarm limits on neonatal mortality and morbidity among infants born very preterm. Study design This was a retrospective cohort study of infants born very preterm in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Infants were classified based on treatment at a hospital with an SpO(2) alarm policy change and study epoch (before vs after policy change). We used a generalized linear mixed model to determine the effect of hospital group and epoch on the primary outcomes of mortality and severe retinopathy of prematurity (ROP) and secondary outcomes of necrotizing enterocolitis, bronchopulmonary dysplasia, and any ROP. Results There were 3809 infants in 10 hospitals with an SpO(2) alarm policy change and 3685 infants in 9 hospitals without a policy change. The nature of most policy changes was to narrow the SpO(2) alarm settings. Mortality was lower in hospitals without a policy change (aOR 0.63; 95% CI 0.50-0.80) but did not differ between epochs in policy change hospitals. The odds of bronchopulmonary dysplasia were greater for hospitals with a policy change (aOR 1.65; 95% CI 1.36-2.00) but did not differ for hospitals without a policy change. Severe ROP and necrotizing enterocolitis did not differ between epochs for either group. The adjusted odds of any ROP were lower in recent years in both hospital groups. Conclusions Changing SpO(2) alarm policies was not associated with reduced mortality or increased severe ROP among infants born very preterm.

Objective To describe discordance in antenatal corticosteroid use and resuscitation following extremely preterm birth and its relationship with infant survival and neurodevelopment. Study design A multicenter cohort study of 4858 infants 22-26 weeks of gestation born 2006-2011 at 24 US hospitals participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network, with follow-up through 2013. Survival and neurodevelopmental outcomes were available at 18-22 months of corrected age for 4576 (94.2%) infants. We described antenatal interventions, resuscitation, and infant outcomes. We modeled the effect on infant outcomes of each hospital increasing antenatal corticosteroid exposure for resuscitated infants born at 22-24 weeks of gestation to rates observed at 25-26 weeks of gestation. Results Discordant antenatal corticosteroid use and resuscitation, where one and not the other occurred, were more frequent for births at 22 and 23 but not 24 weeks (rate ratio [95% CI] at 22 weeks: 1.7 [1.3-2.2]; 23 weeks: 2.6 [2.2-3.2]; 24 weeks: 1.0 [0.8-1.2]) when compared with 25-26 weeks. Among infants resuscitated at 23 weeks, adjusting each hospital's rate of antenatal corticosteroid use to the average at 25-26 weeks (89.2%) was projected to increase infant survival by 7.1% (95% CI 5.4-8.8%) and survival without severe impairment by 6.4% (95% CI 4.7-8.1%). No significant change in outcomes was projected for infants resuscitated at 22 weeks, where few (n = 22) resuscitated infants received antenatal corticosteroids. Conclusions Infants born at 23 weeks were more frequently resuscitated without antenatal corticosteroids than other extremely preterm infants. When resuscitation is intended, consistent provision of antenatal corticosteroids may increase infant survival and survival without impairment.

Objective To evaluate neurodevelopmental outcomes of preterm infants with need for Child Protective Services (CPS) supervision at hospital discharge compared with those discharged without CPS supervision. Study design For infants born at <27 weeks of gestation between 2006 and 2013, prospectively collected maternal and neonatal characteristics and 18- to 26-month corrected age follow-up data were analyzed. Bayley-III cognitive and language scores of infants with discharge CPS supervision were compared with infants without CPS supervision using regression analysis while adjusting for potentially confounding variables, including entering CPS after discharge from the hospital. Results Of the 4517 preterm infants discharged between 2006 and 2013, 255 (5.6%) were discharged with a need for CPS supervision. Mothers of infants with CPS supervision were significantly more likely to be younger, single, and gravida >= 3; to have less than a high school education; and to have a singleton pregnancy and less likely to have received prenatal care or antenatal steroids. Despite similar birth weight and medical morbidities, the CPS group had longer hospital stays compared with the non-CPS group. In adjusted analysis, cognitive scores were points lower (B = -1.94; 95% CI, -3.88 to -0.08; P = .04) in the CPS at discharge group compared with the non-CPS group. In children who entered CPS supervision after hospital discharge (an additional 106 infants), cognitive scores were 4 points lower (beta = -4.76; 95% CI, -7.47 to -2.05; P < .001) and language scores were 5 points lower (beta = -4.93; 95% CI, -8.00 to -1.86; P = .002). Conclusion Extremely preterm infants discharged from the hospital with CPS supervision or entering CPS post-discharge are at increased risk for cognitive delay at 2 years of age. Opportunities exist to intervene and potentially improve outcomes in this vulnerable group of children.

Objective To assess the frequency of gastrostomy tube (GT) placement in extremely low birth weight (ELBW) infants, associated comorbidities, and long-term outcomes. Study design Analysis of ELBW infants from 25 centers enrolled in the National Institute of Child Health and Human Development Neonatal Research Network's Generic Database and Follow-up Registry from 2006 to 2012. Frequency of GT placement before 18-22 months, demographic and medical factors associated with GT placement, and associated long-term outcomes at 18-22 months of corrected age were described. Associations between GT placement and neonatal morbidities and long-term outcomes were assessed with logistic regression after adjustment for center and common co-variables. Results Of the 4549 ELBW infants included in these analyses, 333 (7.3%) underwent GT placement; 76% had the GT placed postdischarge. Of infants with GTs, 11 % had birth weights small for gestational age, 77% had bronchopulmonary dysplasia, and 29% severe intraventricular hemorrhage or periventricular leukomalacia. At follow-up, 56% of infants with a GT had weight <10th percentile, 61 % had neurodevelopmental impairment (NDI), and 55% had chronic breathing problems. After adjustment, small for gestational age, bronchopulmonary dysplasia, intraventricular hemorrhage/periventricular leukomalacia, poor growth, and NDI were associated with GT placement. Thirty-two percent of infants with GTs placed were taking full oral feeds at follow-up. Conclusions GT placement is common in ELBW infants, particularly among those with severe neonatal morbidities. GT placement in this population was associated with poor growth, NDI, and chronic respiratory and feeding problems at follow-up. The frequency of GT placement postneonatal discharge indicates the need for close nutritional follow-up of ELBW infants.

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.

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.

Objectives: Variations in chronic illness care are common in our health care system and may lead to suboptimal outcomes. Specifically, inconsistent use and suboptimal medication dosing have been demonstrated in the care of patients with inflammatory bowel disease (IBD). Quality improvement (QI) efforts have improved outcomes in conditions such as asthma and diabetes mellitus, but have not been well studied in IBD. We hypothesized that QI efforts would lead to improved outcomes in our pediatric IBD population. Methods: A QI team was formed within our IBD center in 2005. By 2007, we began prospectively capturing physician global assessment (PGA) and patient-reported global assessment. Significant QI interventions included creating evidence-based medication guidelines, joining a national QI collaborative, initiation of preclinic planning, and monitoring serum 25-hydroxyvitamin D. Results: From 2007 to 2010, 505 patients have been followed at our IBD center. During this time, the frequency of patients in clinical remission increased from 59% to 76% (P < 0.05), the frequency of patients who report that their global assessment is >7 increased from 69% to 80% (P < 0.05), and the frequency of patients with a Short Pediatric Crohn's Disease Activity Index (sPCDAI) <15 increased from 60% to 77% (P < 0.05). The frequency of repeat steroid use decreased from 17% to 10% (P < 0.05). We observed an association between the use of a vitamin D supplement (P = 0.02), serum 25-hydroxyvitamin D (P < 0.05), and quiescent disease activity. Conclusions: Our results show that significant improvements in patient outcomes are associated with QI efforts that do not rely on new medication or therapies.

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.

OBJECTIVE: To estimate the change in indications for scheduled deliveries during the Ohio Perinatal Quality Collaborative's initiative to decrease scheduled deliveries for nonmedical indications before 39 weeks of gestation.METHODS: Documented indications for scheduled deliveries between 36 0/7 and 38 6/7 weeks were categorized as: strong medically accepted reasons for delivery; intermediate acceptability; and unnecessary before 39 weeks. We describe each of these indication categories as a proportion of all deliveries in the participating hospitals between October 2008 and December 2009.RESULTS: The percentage of scheduled deliveries that were unnecessary before 39 weeks or had intermediate indications decreased over time (P=.03). There were 145 fewer with intermediate reasons and 265 fewer that were unnecessary when the first 4 months of the project were compared with the last 4 months. Strong medical indications as a percentage of all deliveries did not change significantly over time (P=.99).CONCLUSION: Our quality collaborative reduced scheduled deliveries of medically unnecessary and intermediate indications for delivery at 36 0/7 and 38 6/7 weeks. However, scheduled deliveries with strong medical indication did not change significantly over time. (Obstet Gynecol 2012; 120: 241-5) DOI: 10.1097/AOG.0b013e318260d9b2

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.

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.

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.

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] 1 beta; IL-8; tumor necrosis factor-a; 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-beta, soluble IL r alpha, macrophage inflammatory protein 1 beta) 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. (J Pediatr 2011;159:919-25).

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.

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.

We sought to determine the incidence of necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP) in surviving extremely low-birth-weight (ELBW, <1000 g birth weight) infants and to establish the impact of NEC on outcomes by hospital discharge and at 18 to 22 months adjusted age in a large, contemporary, population-based practice. Hospital outcome data for all ELBW infants born in the greater Cincinnati region from 1998 to 2009 were extracted from the National Institute of Child Health Neonatal Research Network Database. Neurodevelopmental outcome at 18 to 22 months was assessed using Bayley Scales of Infant Development-II scores for Mental Developmental Index and Psychomotor Developmental Index. Multivariable logistic regression was used and adjusted odds ratios reported to control for confounders. From 1998 to 2009, ELBW infants accounted for 0.5% of the 352 176 live-born infants in greater Cincinnati. The incidence of NEC was 12%, with a 50% case-fatality rate. Death before discharge, morbid complications of prematurity and neurodevelopmental impairment were all increased among infants diagnosed with NEC. Infants with surgical NEC and SIP had a higher incidence of death, but long-term neurodevelopmental outcomes were not different comparing surviving ELBW infants with medical NEC, surgical NEC and SIP. Although ELBW infants comprise a very small proportion of live-born infants, those who develop NEC and SIP are at an increased risk for death, morbid complications of prematurity and neurodevelopmental impairment. No significant differences in neurodevelopmental outcomes were observed between the medical and surgical NEC and SIP groups.

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.

Delayed cord clamping (DCC) may be beneficial in very-preterm and very-low-birth-weight infants.This study was a randomized unmasked controlled trial. It was performed at three centers of the NICHD (National Institute of Child Health and Human Development) Neonatal Research Network. DCC in very-preterm and very-low-birth-weight infants will result in an increase in hematocrit levels at 4 h of age. Infants with a gestational age of 24 to 28 weeks were randomized to either early cord clamping (<10 s) or DCC (30 to 45 s). The primary outcome was venous hematocrit at 4 h of age. Secondary outcomes included delivery room management, selected neonatal morbidities and the need for blood transfusion during the infants' hospital stay.A total of 33 infants were randomized: 17 to the immediate cord clamping group (cord clamped at 7.9±5.2 s, mean±s.d.) and 16 to the DCC (cord clamped at 35.2±10.1 s) group. Hematocrit was higher in the DCC group (45±8% vs 40±5%, P<0.05). The frequency of events during delivery room resuscitation was almost identical between the two groups. There was no difference in the hourly mean arterial blood pressure during the first 12 h of life; there was a trend in the difference in the incidence of selected neonatal morbidities, hematocrit at 2, 4 and 6 weeks, as well as the need for transfusion, but none of the differences was statistically significant.A higher hematocrit is achieved by DCC in very-low-birth-weight infants, suggesting effective placental transfusion.

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.

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.