An intervention to decrease time to parents' first hold of infants in the Neonatal Intensive Care Unit requiring respiratory support.

BACKGROUND: There are many barriers to parental skin-to-skin contact for critically ill neonates. Our aims were to decrease median time to first parental hold of neonates requiring respiratory support from 6.4 to 3 days, and to increase the percentage of neonates held within the first 24 h after birth from 6 to 75%. METHODS: Lean Six Sigma methodology was used to identify barriers to holding and opportunities for improvement. INTERVENTION: A multifactorial improvement bundle was implemented to reduce the time to first parental hold of critically ill neonates. RESULTS: Median time to first parental hold was reduced from 6.4 to 1.2 days (p < 0.01). Infants held within the first 24 h after birth increased from 6 to 35%. There was no increase in adverse events associated with parental holding. CONCLUSIONS: Implementation of an improvement bundle resulted in a significant reduction in time to first parental hold of infants requiring respiratory support.

State infant mortality: an ecologic study to determine modifiable risks and adjusted infant mortality rates.

OBJECTIVE: To determine factors contributing to state infant mortality rates (IMR) and develop an adjusted IMR in the United States for 2001 and 2002. DESIGN/METHODS: Ecologic study of factors contributing to state IMR. State IMR for 2001 and 2002 were obtained from the United States linked death and birth certificate data from the National Center for Health Statistics. Factors investigated using multivariable linear regression included state racial demographics, ethnicity, state population, median income, education, teen birth rate, proportion of obesity, smoking during pregnancy, diabetes, hypertension, cesarean delivery, prenatal care, health insurance, self-report of mental illness, and number of in-vitro fertilization procedures. Final risk adjusted IMR's were standardized and states were compared with the United States adjusted rates. RESULTS: Models for IMR in individual states in 2001 (r2 = 0.66, P < 0.01) and 2002 (r2 = 0.81, P < 0.01) were tested. African-American race, teen birth rate, and smoking during pregnancy remained independently associated with state infant mortality rates for 2001 and 2002. Ninety five percent confidence intervals (CI) were calculated around the regression lines to model the expected IMR. After adjustment, some states maintained a consistent IMR; for instance, Vermont and New Hampshire remained low, while Delaware and Louisiana remained high. However, other states such as Mississippi, which have traditionally high infant mortality rates, remained within the expected 95% CI for IMR after adjustment indicating confounding affected the initial unadjusted rates. CONCLUSIONS: Non-modifiable demographic variables, including the percentage of non-Hispanic African-American and Hispanic populations of the state are major factors contributing to individual variation in state IMR. Race and ethnicity may confound or modify the IMR in states that shifted inside or outside the 95% CI following adjustment. Other factors including smoking during pregnancy and teen birth rate, which are potentially modifiable, significantly contributed to differences in state IMR. State risk adjusted IMR indicate that other factors impact infant mortality after adjustment by race/ethnicity and other risk factors.

Increasing illness severity in very low birth weight infants over a 9-year period.

BACKGROUND: Recent reports have documented a leveling-off of survival rates in preterm infants through the 1990's. The objective of this study was to determine temporal changes in illness severity in very low birth weight (VLBW) infants in relationship to the outcomes of death and/or severe IVH. METHODS: Cohort study of 1414 VLBW infants cared for in a single level III neonatal intensive care unit in Delaware from 1993-2002. Infants were divided into consecutive 3-year cohorts. Illness severity was measured by two objective methods: the Score for Neonatal Acute Physiology (SNAP), based on data from the 1st day of life, and total thyroxine (T4), measured on the 5th day of life. Death before hospital discharge and severe intraventricular hemorrhage (IVH) were investigated in the study sample in relation to illness severity. The fetal death rate was also investigated. Statistical analyses included both univariate and multivariate analysis. RESULTS: Illness severity, as measured by SNAP and T4, increased steadily over the 9-year study period with an associated increase in severe IVH and the combined outcome of death and/or severe IVH. During the final 3 years of the study, the observed increase in illness severity accounted for 86% (95% CI 57-116%) of the variability in the increase in death and/or severe IVH. The fetal death rate dropped from 7.8/1000 (1993-1996) to 5.3/1000 (1999-2002, p = .01) over the course of the study. CONCLUSION: These data demonstrate a progressive increase in illness in VLBW infants over time, associated with an increase in death and/or severe IVH. We speculate that the observed decrease in fetal death, and the increase in neonatal illness, mortality and/or severe IVH over time represent a shift of severely compromised patients that now survive the fetal time period and are presented for care in the neonatal unit.

Maternal antibiotics and decreased periventricular leukomalacia in very low-birth-weight infants.

OBJECTIVE: To investigate the effect of maternal antibiotics, given in the predelivery period, on neonatal outcomes. DESIGN: Retrospective cohort study. SETTING: A single level 3 neonatal intensive care unit. PATIENTS: All infants with birth weights 1500 g or less cared for from July 1994 to July 2000 (n = 834) were included in the study. Mothers were classified as receiving antibiotics if they received any parenteral antibiotics in the predelivery period. Infants whose mothers received antibiotics were compared with infants whose mothers received no antibiotics. MAIN OUTCOME MEASURES: The main outcome variables studied included intraventricular hemorrhage (IVH), cystic periventricular leukomalacia (PVL), sepsis, and mortality. RESULTS: Of 834 mothers, 374 (45%) received antibiotics prior to delivery. On univariate analysis, there were no differences in the relative risk (RR) of mortality (1.26; 95% confidence interval [CI], 0.86-1.79) or grades 3 to 4 IVH (RR, 1.39; 95% CI, 0.82-1.90) between the antibiotics and no-antibiotics groups. Infants born to mothers receiving antibiotics had an increased risk of culture-proven sepsis (RR, 1.4; 95% CI, 1.02-1.64) and a decreased risk of cystic PVL (RR, 0.26; 95% CI, 0.09-0.79) compared with infants whose mothers did not receive antibiotics. After controlling for confounding variables, maternal antibiotics were not associated with a decrease in the risk of mortality (adjusted risk [AR], 1.0; 95% CI, 0.5-2.1), grades 3 to 4 IVH (AR, 1.0; 95% CI, 0.5-1.9), or sepsis (AR, 0.9; 95% CI, 0.7-1.4). However, the use of maternal antibiotics was associated with a decreased risk of developing cystic PVL (AR, 0.09; 95% CI, 0.02-0.5). CONCLUSIONS: In our population of very low-birth-weight infants, maternal antibiotics were associated with a decreased risk of cystic PVL. Maternal antibiotics do not change the risk of mortality, sepsis, or severe IVH.

Factors influencing levels of 17-hydroxyprogesterone in very low birth weight infants and the relationship to death and IVH.

OBJECTIVES: 17-Hydroxyprogesterone, an intermediary hormone in cortisol synthesis, has been shown to be elevated in premature infants. However, the relationship between levels of 17-hydroxyprogesterone with death and intraventricular hemorrhage has not been extensively explored. The objective of this study was to determine the factors influencing 17-hydroxyprogesterone and determine if there is an association between intraventricular hemorrhage, mortality, and levels of 17-hydroxyprogesterone in a population of very low birth weight infants. STUDY DESIGN: Cohort study of very low birth weight infants cared for at a single level 3 NICU during a 1-year period from July 2001 to July 2002. Infants had a minimum of one screen for 17-hydroxyprogesterone and one cranial sonogram. 17-Hydroxyprogesterone was measured on the fifth day of life and at 2 to 4 weeks of life as part of the State of Delaware Newborn Screening Program. Statistical analysis included chi(2), Pearson correlation, multiple-linear regression, and logistic regression. RESULTS: Levels of 17-hydroxyprogesterone were higher at the time of the first screen compared to the second screen (28.3+/-25.6 vs 17.0+/-18.0 ng/ml, p=0.01), respectively. After controlling for potential confounding variables, gestational age, T(4), and prenatal steroids were all independently associated with 17-hydroxyprogesterone. However, logistic regression analysis showed no association between a 1 log increase in levels of 17-hydroxyprogesterone with the outcomes of death (odds ratio 1.8, 95% CI 0.6 to 5.6), severe IVH (0.7, 0.3 to 1.7), and death and/or severe intraventricular hemorrhage (0.9, 0.4 to 2.1). CONCLUSIONS: In our population of very low birth weight infants, low gestational age, low T(4), and prenatal steroids were all associated with an elevation in levels of 17-hydroxyprogesterone. High levels of 17-hydroxyprogesterone were not associated with death and/or severe IVH. Our data indicate that factors such as gestational age and antenatal steroids must be considered when interpreting 17-hydroxyprogesterone results from newborn screening.

Effect of inhaled corticosteroids on markers of pulmonary inflammation and lung maturation in preterm infants with evolving chronic lung disease.

BACKGROUND: Chronic lung disease (CLD) is one of the most severely disabling conditions of extremely low-birth-weight infants. Systemic corticosteroids are effective but cause many adverse effects. Targeted therapy with inhaled corticosteroids may be an effective and less toxic alternative. STUDY OBJECTIVE: To evaluate the additive effect of inhaled corticosteroids on markers of lung inflammation in infants receiving a 7-day course of systemic steroids. METHODS: Preterm neonates weighing 1 kg or less and aged 12 to 28 days who were prescribed a 7-day course of systemic corticosteroids for evolving CLD were studied prospectively and randomized to receive either a tapering 4-week course of beclomethasone metered-dose inhaler (MDI) (n = 5) or placebo MDI (n = 6). Primary outcome variables were the levels of pro- and anti-inflammatory cytokines, IL-8, TNF-alpha, IL-1alpha, and sIL-2R. RESULTS: This study was terminated early following literature reports of the adverse neurodevelopmental effects of dexamethasone. Measurements of respiratory and serum IL-8, IL-1alpha and TNF-alpha were similar between the study group taking inhaled and systemic corticosteroids and the study group taking systemic steroids alone. No differences were found between the two groups in relation to dynamic compliance or resistance. CONCLUSIONS: The addition of inhaled corticosteroids to a 7-day systemic course of corticosteroids did not alter cytokine response or improve pulmonary function.

Is infant mortality in Delaware truly increasing? Evidence for increasing illness severity and shift to fetal deaths and previable births.

The infant mortality rate, considered an important proxy for societal health, has been recently rising in Delaware. In fact, in 2001, Delaware's infant mortality rate (10.1/1,000 births) was the highest in the country. In this review, potential factors leading to increasing infant mortality in Delaware are discussed. Evidence for increasing illness severity in infants with birth weights less than 1,500 grams and an increasing number of live, yet previable, births is presented.

Home delivery of palivizumab: outcomes and compliance in regional preterm infants.

Palivizumab, a monoclonal antibody against respiratory syncytial virus (RSV), has been shown to be effective in preventing RSV-related hospitalization in preterm infants; however, ensuring infants receive the desired monthly injections remains a challenge. We studied two cohorts of preterm infants and the rate of documented RSV illness in infants receiving palivizumab at home between 1998 and 2000. Medical records were reviewed for the number of doses received, hospitalization for RSV illness, and other demographic data. Parents in Cohort 1, 1998-1999, were prospectively surveyed to determine satisfaction with delivery of palivizumab. In Cohort 1, the home group (n = 32) received 89 +/- 19 percent of their scheduled course as compared to 66 +/- 32 percent in the office group (n = 41, p < .01), with 67 percent in the home group receiving their entire scheduled course as compared to 36 percent in the office group (p = .02). Of the parents surveyed, 70 percent in the home group indicated that they were satisfied with the way palivizumab was administered as compared to 76 percent in the office group (p = .44). In Cohort 2, 1999-2000, 175 infants received palivizumab at home, and 161 of these (92 percent) completed therapy as ordered. None of the infants had a documented infection with RSV. In our population infants receiving palivizumab at home were more likely to receive their entire scheduled course and less likely to miss doses than infants receiving palivizumab in an office setting. The high rate of compliance with home delivery is associated with a low rate of documented severe RSV illness.

The influence of family characteristics on perinatal decision making.

OBJECTIVE: To determine whether parental characteristics affect estimates of best interests and intervention decisions for preterm infants. DESIGN AND METHODS: The study consisted of an anonymous questionnaire given to nurses, physicians, and students. The study included scenarios of 3 sets of parents, including a 16-year-old teenager, a couple who were lawyers, and a couple with a history of in vitro fertilization, about to deliver at 22 5/7 weeks, 24 weeks, or 27 5/7 weeks. Respondents were asked whether active intervention is in the infant's best interests and whether they would comply with family decisions. RESULTS: A total of 1105 questionnaires were sent out, with 829 respondents in Canada and the United States. At 22 5/7 weeks' gestation, 21% of the respondents thought that resuscitation was in the infant's best interest; among respondents who did not agree, 59% would intervene if the parents wished. At 27 5/7 weeks' gestation, 95% of respondents thought that resuscitation was in the infant's best interest, yet 34% would accept comfort care. Estimates of best interest, and willingness to comply, varied significantly by parental characteristics. At 22 5/7 weeks' gestation, 17% of respondents believed that resuscitation was in the best interest of the teenaged mother's infant compared with 26% of respondents who believed that resuscitation was in the best interest for the infants of the others; this difference persisted at 24 weeks. At 22 5/7 and at 24 weeks' gestation, compliance with active care despite believing that it not in the infant's best interest was significantly more frequent for the in vitro fertilization couple and the lawyers than for the teenaged mother. At 27 weeks' gestation, more than 93% of respondents complied for all parents. CONCLUSIONS: Caregivers frequently are ready to intervene actively, or not, despite believing that it is against the infant's best interest. Willingness to do so varies according to parental characteristics.

Caesarean delivery and outcome in very low birthweight infants.

OBJECTIVE: To determine the relationship between mode of delivery, intraventricular haemorrhage (IVH), and mortality in very low birthweight (VLBW) infants. STUDY DESIGN: A historical cohort study of infants admitted to a single level III neonatal intensive care unit during a five-year period. Infants < 1500 g born by caesarean delivery (n = 400) were compared to those born by vaginal delivery (n = 305). RESULTS: After controlling for potential confounding variables including: gestational age, fetal presentation, and multiple birth, caesarean delivery was not associated with a decreased odds of IVH (odds ratio 1.2, 95% CI 0.7-2.0), severe IVH (1.9, 0.9-4.0), or mortality (1.2, 0.6-2.4). CONCLUSIONS: In our population of very low birthweight infants, caesarean delivery is not associated with a decreased risk for mortality or intraventricular haemorrhage.

Transfusion volume in infants with very low birth weight: a randomized trial of 10 versus 20 ml/kg.

BACKGROUND: Although preterm infants often require transfusions of red blood cells for anemia of prematurity, the optimal volume of blood to be transfused has not been established. OBSERVATIONS: Infants with birth weights between 500 and 1,500 g were randomly assigned to receive 10 or 20 mL/kg red blood cells. Infants with transfusions of 20 mL/kg had a greater hemoglobin (14.2 +/- 1.9 vs. 12.0 +/- 1.9 g/dL, P = 0. 003) and hematocrit (41.2 +/- 5.9 vs. 32.3 +/- 7.1%, P = 0.001) levels after transfusion compared with those who received transfusions of 10 mL/kg. There were no measured differences in pulmonary function in either group after transfusion. CONCLUSIONS: Transfusion with 20 mL/kg red blood cells produces a significantly greater increase in hemoglobin and hematocrit levels than does a transfusion with 10 mL/kg, without any detrimental effects on pulmonary function.

Are perinatal risk factors helpful in predicting and optimizing treatment strategies for transient hypothyroxinemia in very-low-birth-weight infants?

Transient hypothyroxinemia is common in premature infants and has been associated with intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), poor neurodevelopmental outcomes, and mortality. Recent trials have failed to show that supplemental thyroid hormone improves overall neurodevelopmental outcome. The objective of this article is too determine perinatal risk factors for transient hypothyroxinemia (TH). We studied a cohort of infants born between July 1993 and July 2000 who were less than 1500 g and who received a newborn screening for thyroid function ( n = 932). Total serum thyroxine (T(4)) was collected routinely on the fifth day of life. T (4) was correlated with gestational age (R = 0.59, p < 0.01). After controlling for potential confounding variables, gestational age, dopamine, and mechanical ventilation were found to be independently associated with low T (4) (overall model: r(2) = 0.41, p < 0.01). Number needed to treat (NNT) analysis showed treating all infants less than 27 weeks would lead to treating 6.3 infants for every one with a subsequent T(4) < 5 microg/dL. By combining gestational age and need for dopamine support, NNT = 2.4 for every one infant with subsequent T(4) < 5 microg/dL. Low gestational age, mechanical ventilation, and need for dopamine were associated with low T(4) levels and may be helpful in optimizing treatment strategies for TH.