Measles-mumps-rubella and varicella vaccine responses in extremely preterm infants.
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OBJECTIVE: Extremely preterm infants mount lower antibody responses than term infants to several vaccines. The objective of this study was to measure the immunogenicity of measles-mumps-rubella and varicella vaccines in preterm and term children. METHODS: Immune status before immunization and immune response after immunization with measles-mumps-rubella and varicella vaccines at 15 months of age were compared in 32 infants, 16 of whom were preterm (< 29 weeks' gestation) and 16 of whom were term (> or = 37 weeks' gestation) at birth. Blood was drawn before vaccination and 3 to 6 weeks thereafter. Measles antibody was measured by plaque reduction neutralization assay. Mumps and rubella immunoglobulin G were measured in available sera by enzyme-linked fluorescent immunoassay. Varicella immunoglobulin G was measured in available sera by glycoprotein enzyme-linked immunosorbent assay. Values that were above or below the assay limits were assigned values double or half those limits, respectively. The primary outcome was the geometric mean antibody titer. RESULTS: Preterm children had lower mumps and rubella geometric mean titers than did term children before vaccine, and nearly all children were seronegative for each of the 4 vaccine antigens before immunization. Measles, mumps, rubella, and varicella geometric mean titers were similar between groups after vaccine. All children were seropositive for measles after vaccine, whereas 13 of 14 preterm and 11 of 13 term children were seropositive for mumps, 13 of 14 preterm and 13 of 13 term children were seropositive for rubella, and 11 of 16 preterm and 9 of 15 term children were seropositive for varicella. CONCLUSIONS: Preterm children mounted antibody responses that were similar to those of term children after measles-mumps-rubella and varicella vaccines at 15 months of age. (+info)
Neurodevelopmental and growth outcomes of extremely low birth weight infants who are transferred from neonatal intensive care units to level I or II nurseries.
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OBJECTIVE: Transfer of clinically stable infants to level I and II nurseries alleviates demands on NICUs and allows better use of beds and resources. This study compared growth, neurodevelopmental impairments, postdischarge rehospitalization and deaths, and compliance for follow-up assessment at 18 to 22 months' corrected age of extremely low birth weight infants who transferred to level I and II nurseries with those who continued to receive care to discharge in a NICU. METHODS: A retrospective analysis of prospectively collected data from the National Institute of Child Health and Human Development Neonatal Research Network was performed. Between January 1998 and June 2002, 4896 infants born with birth weights of 401 to 1000 g and cared for in 19 National Institute of Child Health and Human Development Neonatal Research Network centers were included. The sample consisted of 4392 survivors who received continuing care in the NICU to discharge home and 504 infants who were transferred to level I and II nurseries before discharge home. Demographics, perinatal characteristics, growth, and neurodevelopmental impairments were compared. Bivariate and logistic regression analyses were performed. RESULTS: Transfer of infants to level I and II nurseries was associated significantly with white race, private insurance, outborn status, and lower neonatal morbidities and compliance for follow-up compared with the NICU group. After adjusting for known covariates, transfer to level I and II nurseries was not associated with neurodevelopmental impairments or death; however, it was associated with increased postdischarge rehospitalization. CONCLUSIONS: Extremely low birth weight infants who are transferred to level I and II nurseries have similar growth and neurodevelopmental outcomes to infants who are discharged from a NICU. They are, however, more likely to be readmitted to the hospital and are less compliant for follow-up. Establishment of consistent guidelines for comprehensive discharge planning for level I and II nurseries may improve follow-up compliance and reduce rehospitalization rates among these infants who are transferred. (+info)
Outcome at 2 years of age of infants from the DART study: a multicenter, international, randomized, controlled trial of low-dose dexamethasone.
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OBJECTIVE: Low-dose dexamethasone facilitates extubation in chronically ventilator-dependent infants with no obvious short-term complications. The objective of this study was to determine the long-term effects of low-dose dexamethasone. METHODS: Very preterm (<28 weeks' gestation) or extremely low birth weight (birth weight <1000 g) infants who were ventilator dependent after the first week of life for whom clinicians considered corticosteroids were indicated were eligible. After informed consent, infants were randomly assigned to masked dexamethasone (0.89 mg/kg over 10 days) or saline placebo. Survivors were assessed at 2 years' corrected age by staff blinded to treatment group allocation to determine neurosensory outcome, growth, and health. RESULTS: The trial was abandoned well short of its target sample size because of recruitment difficulties. Seventy infants were recruited from 11 centers, 35 in each group: 59 survived to 2 years of age, and 58 (98%) were assessed at follow-up, but data for cerebral palsy were available for only 56 survivors. There was little evidence for a difference in the major end point, the rate of the combined outcome of death, or major disability at 2 years of age (dexamethasone group: 46%; controls: 43%). Rates of mortality before follow-up (11% vs 20%), major disability (41% vs 31%), cerebral palsy (14% vs 22%), or of the combined outcomes of death or cerebral palsy (23% vs 37%) were not substantially different between the groups. There were no obvious effects of low-dose dexamethasone on growth or readmissions to hospital after discharge. CONCLUSIONS: Although this trial was not able to provide definitive evidence on the long-term effects of low-dose dexamethasone after the first week of life in chronically ventilator-dependent infants, our data indicate no strong association with long-term morbidity. (+info)
Outcomes attributable to neonatal candidiasis.
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BACKGROUND: The incidence of candidiasis has increased in neonatal intensive care units, and invasive candidiasis is associated with significant morbidity and mortality. However, few data exist on outcomes directly attributable to neonatal candidiasis. METHODS: We estimated the incidence of systemic candidiasis in hospitalized neonates within the United States and determined the attributable mortality, length of hospital stay, and associated costs. We used the 2003 Kid's Inpatient Database from the Healthcare Cost and Utilization Project. Systemic candidiasis and comorbidities were defined by International Classification of Diseases, Ninth Revision, Clinical Modification codes. Neonates with uncomplicated births and neonates who died within the first 3 days of life were excluded. We used propensity score methods to balance covariates between the neonates with and neonates without candidiasis. Attributable outcomes were calculated between propensity score-matched neonates with and neonates without candidiasis. Because of the known confounding effect of birth weight, we performed separate propensity score analyses for extremely low birth weight (ELBW) neonates (i.e., neonates weighing < 1000 g). RESULTS: The overall incidence of invasive candidiasis in neonates is 15 cases per 10,000 neonatal admissions (95% confidence interval [CI], 13-16 cases per 10,000 neonatal admissions). ELBW neonates with invasive candidiasis were 2 times more likely to die (odds ratio, 2.2; 95% CI, 1.4-3.5) than propensity-matched ELBW neonates without candidiasis. The propensity score-adjusted mortality rate attributable to candidiasis among ELBW neonates was 11.9%. Candidiasis in ELBW infants was not associated with an increase in length of hospital stay but was associated with a mean increase in total charges of $39,045 (95% CI, $1374-$76,715). Among infants with a birth weight > or = 1000 g, those who had candidiasis did not experience a significant increase in mortality, compared with infants without candidiasis. However, the propensity score-adjusted length of stay and charges attributable to candidiasis among neonates with a birth weight > or = 1000 g were 16 days (95% CI, 8-24 days) and $122,302 (95% CI, $80,457-$164,148), respectively. CONCLUSIONS: Invasive candidiasis is associated with a significantly increased risk of death and excess hospital charges in ELBW neonates and with excess hospital stay and excess hospital charges in neonates with a birth weight > or = 1000 g. (+info)
Long-term visual outcomes in extremely low-birth-weight children (an American Ophthalmological Society thesis).
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PURPOSE: The goal is to analyze the long-term visual outcome of extremely low-birth-weight children. METHODS: This is a retrospective analysis of eyes of extremely low-birth-weight children on whom vision testing was performed. Visual outcomes were studied by analyzing acuity outcomes at >/=36 months of adjusted age, correlating early acuity testing with final visual outcome and evaluating adverse risk factors for vision. RESULTS: Data from 278 eyes are included. Mean birth weight was 731g, and mean gestational age at birth was 26 weeks. 248 eyes had grating acuity outcomes measured at 73 +/- 36 months, and 183 eyes had recognition acuity testing at 76 +/- 39 months. 54% had below normal grating acuities, and 66% had below normal recognition acuities. 27% of grating outcomes and 17% of recognition outcomes were /=3 years of age. A slower-than-normal rate of early visual development was predictive of abnormal grating acuity (P < .0001) and abnormal recognition acuity (P < .0001) at >/=3 years of age. Eyes diagnosed with maximal retinopathy of prematurity in zone I had lower acuity outcomes (P = .0002) than did those with maximal retinopathy of prematurity in zone II/III. Eyes of children born at 28 weeks gestational age. Eyes of children with poorer general health after premature birth had a 5.3 times greater risk of abnormal recognition acuity. CONCLUSIONS: Long-term visual development in extremely low-birth-weight infants is problematic and associated with a high risk of subnormal acuity. Early acuity testing is useful in identifying children at greatest risk for long-term visual abnormalities. Gestational age at birth of +info)
One-year follow-up of very preterm infants who received lucinactant for prevention of respiratory distress syndrome: results from 2 multicenter randomized, controlled trials.
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BACKGROUND: The benefits of exogenous surfactants for prevention or treatment of respiratory distress syndrome are well established, but there is a paucity of long-term follow-up data from surfactant-comparison trials. OBJECTIVE: We sought to determine and compare survival and pulmonary and neurodevelopmental outcomes through 1 year corrected age of preterm infants who received lucinactant and other surfactants in the SELECT (Safety and Effectiveness of Lucinactant Versus Exosurf in a Clinical Trial) and STAR (Surfaxin Therapy Against Respiratory Distress Syndrome) trials individually and, secondarily, from analysis using combined data from these 2 trials. METHODS: All infants from both trials who were randomly assigned to administration of lucinactant (175 mg/kg), colfosceril palmitate (67.5 mg/kg), beractant (100 mg/kg), or poractant alfa (175 mg/kg) were prospectively followed through 1 year corrected age, at which point masked assessment of outcomes was performed for surviving infants. One-year survival was a key outcome of interest. Other parameters assessed included rates of rehospitalization and respiratory morbidity and gross neurologic status. Data were analyzed by comparing the different surfactants within each trial and, in secondary analysis, combining data from both trials to compare lucinactant versus the animal-derived surfactants (beractant and poractant) used in these trials. Survival rates over time were compared by using the Wilcoxon test for survival through 1 year corrected age and logistic regression for comparison of fixed time points. The latter analyses were performed by using the prespecified approach, where loss to follow-up or withdrawal of consent was imputed as a death, and also using raw data. Other outcomes were analyzed by using the Cochran-Mantel-Haenszel test or logistic regression for categorical data, and analysis of variance on ranks was used for continuous data. RESULTS: Very few cases were lost to follow-up in either trial (29 of 1546 enrolled in both trials [1.9%]). In the primary analysis of the SELECT trial comparing lucinactant to either colfosceril or beractant, there were no significant differences in the proportion of infants who were alive through 1 year corrected age. Fixed-time-point estimates of mortality at 1 year corrected age imputing loss to follow-up as a death were 28.1% for lucinactant, 31.0% for colfosceril, and 31.0% for beractant. By using raw data without imputing loss to follow-up as a death, mortality estimates at 1 year corrected age were computed to be 26.6%, 29.1%, and 28.3%, respectively. In the primary analysis of the STAR trial, significantly more infants treated with lucinactant were alive through 1 year corrected age compared with those who received poractant alfa. Fixed time estimates of mortality at 1 year corrected age imputing loss to follow-up as a death were 19.4% for lucinactant and 24.2% for poractant. These estimates using raw data that did not impute loss to follow-up as a death were 18.6% and 21.9%, respectively. In the combined analysis, survival through 1 year corrected age was higher for infants in the lucinactant group versus that of the infants in the animal-derived surfactants (beractant and poractant) group. The fixed-time-point estimates of mortality at 1 year corrected age imputing loss to follow-up as a death for lucinactant and animal-derived surfactants were 26.0% and 29.4%, respectively. However, the 1-year-corrected-age estimates using combined raw data were 24.6% for the lucinactant group and 26.7% for the animal-derived surfactant group. The incidence of postdischarge rehospitalizations, total number of rehospitalizations, incidence of respiratory illnesses, and total number of respiratory illnesses were generally similar among those in the treatment groups. Neurologic status at 1 year corrected age was essentially similar between infants who received lucinactant and those who received all other surfactants used in these 2 trials. CONCLUSIONS: Findings from this 1-year follow-up of both lucinactant trials indicate that this new peptide-based synthetic surfactant is at least as good, if not superior, to animal-derived surfactants for prevention of respiratory distress syndrome and may be a viable alternative to animal-derived products. (+info)
Azithromycin in the extremely low birth weight infant for the prevention of bronchopulmonary dysplasia: a pilot study.
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BACKGROUND: Azithromycin reduces the severity of illness in patients with inflammatory lung disease such as cystic fibrosis and diffuse panbronchiolitis. Bronchopulmonary dysplasia (BPD) is a pulmonary disorder which causes significant morbidity and mortality in premature infants. BPD is pathologically characterized by inflammation, fibrosis and impaired alveolar development. The purpose of this study was to obtain pilot data on the effectiveness and safety of prophylactic azithromycin in reducing the incidence and severity of BPD in an extremely low birth weight (< or = 1000 grams) population. METHODS: Infants < or = 1000 g birth weight admitted to the University of Kentucky Neonatal Intensive Care Unit (level III, regional referral center) from 9/1/02-6/30/03 were eligible for this pilot study. The pilot study was double-blinded, randomized, and placebo-controlled. Infants were randomized to treatment or placebo within 12 hours of beginning mechanical ventilation (IMV) and within 72 hours of birth. The treatment group received azithromycin 10 mg/kg/day for 7 days followed by 5 mg/kg/day for the duration of the study. Azithromycin or placebo was continued until the infant no longer required IMV or supplemental oxygen, to a maximum of 6 weeks. Primary endpoints were incidence of BPD as defined by oxygen requirement at 36 weeks gestation, post-natal steroid use, days of IMV, and mortality. Data was analyzed by intention to treat using Chi-square and ANOVA. RESULTS: A total of 43 extremely premature infants were enrolled in this pilot study. Mean gestational age and birth weight were similar between groups. Mortality, incidence of BPD, days of IMV, and other morbidities were not significantly different between groups. Post-natal steroid use was significantly less in the treatment group [31% (6/19)] vs. placebo group [62% (10/16)] (p = 0.05). Duration of mechanical ventilation was significantly less in treatment survivors, with a median of 13 days (1-47 days) vs. 35 days (1-112 days)(p = 0.02). CONCLUSION: Our study suggests that azithromycin prophylaxis in extremely low birth weight infants may effectively reduce post-natal steroid use for infants. Further studies are needed to assess the effects of azithromycin on the incidence of BPD and possible less common side effects, before any recommendations regarding routine clinical use can be made. (+info)
Human milk intake and retinopathy of prematurity in extremely low birth weight infants.
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OBJECTIVES: Our goal was to analyze the association between human milk intake and severe retinopathy of prematurity in extremely low birth weight infants. PATIENTS AND METHODS: This study is a secondary analysis of data collected for a trial of glutamine supplementation in extremely low birth weight infants (birth weight <1000 g). Among the 1433 participants in that trial, data are available regarding human milk intake and the occurrence of severe retinopathy of prematurity (defined in this study as retinopathy of prematurity treated surgically) for 1057 infants. The volume of human milk intake was expressed as the mean volume (milliliters per kilogram per day) and the mean proportional volume (proportion of total nutritional intake) from birth to discharge or transfer. Using logistic regression, we estimated odds ratios and 95% confidence intervals for any human milk intake and, among infants who received human milk, for each 10 mL/kg per day and each 10% increase in volume. RESULTS: Of the 1057 infants included in this cohort, 788 infants (75%) received at least some human milk. Among these milk-fed infants, the median volume of human milk intake was 30 mL/kg per day (interquartile range: 6-83 mL/kg per day), and the median proportional volume of human milk intake was 0.18 (interquartile range: 0.03-0.66). One hundred sixty-three infants (15%) developed severe retinopathy of prematurity. CONCLUSIONS: In extremely low birth weight infants, human milk intake was not associated with a decreased risk of severe retinopathy of prematurity. (+info)