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  • 1
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 117, No. 2 ( 2006-02-01), p. e137-e142
    Abstract: OBJECTIVE. We sought to determine if an association exists between the use of histamine-2 receptor (H2) blockers and the incidence of necrotizing enterocolitis (NEC) in infants of 401 to 1500 g in birth weight. STUDY DESIGN. Data from the National Institute of Child Health and Human Development Neonatal Research Network very low birth weight (401–1500 g) registry from September 1998 to December 2001 were analyzed. The relation between the diagnosis of NEC (Bell stage II or greater) and antecedent H2-blocker treatment was determined by using case-control methodology. Conditional logistic regression was implemented, controlling for gender, site of birth (outborn versus inborn), Apgar score of & lt;7 at 5 minutes, and postnatal steroids. RESULTS. Of 11072 infants who survived for at least 12 hours, 787 (7.1%) developed NEC (11.5% of infants 401–750 g, 9.1% of infants 751–1000 g, 6.0% of infants 1001–1250 g, and 3.9% of infants 1251–1500 g). Antecedent H2-blocker use was associated with an increased incidence of NEC (P & lt; .0001). CONCLUSIONS. H2-blocker therapy was associated with higher rates of NEC, which is in agreement with a previous randomized trial of acidification of infant feeds that resulted in a decreased incidence of NEC. In combination, these data support the hypothesis that gastric pH level may be a factor in the pathogenesis of NEC.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 2006
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  • 2
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 119, No. 5 ( 2007-05-01), p. 876-890
    Abstract: OBJECTIVE. We tested whether NICU teams trained in benchmarking and quality improvement would change practices and improve rates of survival without bronchopulmonary dysplasia in inborn neonates with birth weights of & lt;1250 g. METHODS. A cluster-randomized trial enrolled 4093 inborn neonates with birth weights of & lt;1250 g at 17 centers of the National Institute of Child Health and Human Development Neonatal Research Network. Three centers were selected as best performers, and the remaining 14 centers were randomized to intervention or control. Changes in rates of survival free of bronchopulmonary dysplasia were compared between study year 1 and year 3. RESULTS. Intervention centers implemented potentially better practices successfully; changes included reduced oxygen saturation targets and reduced exposure to mechanical ventilation. Five of 7 intervention centers and 2 of 7 control centers implemented use of high-saturation alarms to reduce oxygen exposure. Lower oxygen saturation targets reduced oxygen levels in the first week of life. Despite these changes, rates of survival free of bronchopulmonary dysplasia were all similar between intervention and control groups and remained significantly less than the rate achieved in the best-performing centers (73.3%). CONCLUSIONS. In this cluster-randomized trial, benchmarking and multimodal quality improvement changed practices but did not reduce bronchopulmonary dysplasia rates.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 2007
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  • 3
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 120, No. 2 ( 2007-08-01), p. 456-457
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 2007
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  • 4
    In: JAMA Pediatrics, American Medical Association (AMA), Vol. 170, No. 12 ( 2016-12-01), p. 1164-
    Type of Medium: Online Resource
    ISSN: 2168-6203
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2016
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  • 5
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 108, No. 4 ( 2001-10-01), p. 934-942
    Abstract: Infants of ≤1250 g birth weight receive multiple erythrocyte transfusions during their hospitalization. We hypothesized that early erythropoietin (Epo) and iron therapy would 1) decrease the number of transfusions received (infants 401-1000 g birth weight; trial 1) and 2) decrease the percentage of infants who received any transfusions (1001–1250 g birth weight; trial 2). Methods. A total of 172 infants in trial 1 and 118 infants in trial 2 were randomized to treatment (Epo, 400 U/kg 3 times weekly) or placebo/control. Therapy was initiated by 4 days after birth and continued through the 35th postmenstrual week. All infants received supplemental parenteral and enteral iron. Complete blood and reticulocyte counts were measured weekly, and ferritin concentrations were measured monthly. Transfusions were administered according to protocol. Phlebotomy losses and transfusion data were recorded. Results. Treated and placebo/control infants in trial 1 received a similar number of transfusions (4.3 ± 3.6 vs 5.2 ± 4.2, respectively). A similar percentage of treated and control infants in trial 2 received at least 1 transfusion (37% vs 46%). Reticulocyte counts were higher in treated infants during each week of the study in both trials. Hematocrits were higher among treated infants from week 2 on in both trials. Ferritin concentrations were higher in placebo/controls than in treated infants at weeks 4 and 8 in trial 1 and at week 4 in trial 2. No adverse effects of Epo or supplemental iron occurred. Conclusion. The combination of early Epo and iron as administered in this study stimulated erythropoiesis in infants who were ≤1250 g at birth. However, the lack of impact on transfusion requirements fails to support routine use of early Epo.neonate, intravenous iron, donor exposure.
    Type of Medium: Online Resource
    ISSN: 1098-4275 , 0031-4005
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 2001
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  • 6
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 112, No. 4 ( 2003-10-01), p. 773-779
    Abstract: Objective. To assess the association between peak total serum bilirubin (PSB) levels during the first 2 weeks of life and neurodevelopmental outcomes of extremely low birth weight (ELBW) infants at 18 to 22 months’ postmenstrual age. Methods. A retrospective analysis was conducted of a cohort of ELBW infants (401–1000 g) who survived to 14 days of age in the 12 participating centers of the National Institute of Child Health and Human Development Neonatal Research Network between January 1, 1994, and December 31, 1997. Demographic and clinical risk factors and PSB levels during the first 14 days were analyzed with reference to death or adverse neurodevelopmental outcomes at 18 to 22 months’ postmenstrual age. The neurodevelopmental variables considered were Psychomotor Developmental Index (PDI) & lt;70, Mental Developmental Index (MDI) & lt;70, moderate or severe cerebral palsy (CP), hearing impairment (needs hearing aids), and a composite category designated as neurodevelopmental impairment (NDI). The NDI is defined as infants with any 1 or more of the following: PDI & lt;70, MDI & lt;70, moderate to severe CP, bilateral blindness, or bilateral hearing impairment requiring amplification. Results. The subjects of this cohort analysis are infants who were admitted to the Network centers during calendar years 1994–1997 and survived beyond 14 days and had PSB recorded during the 14-day period. From this cohort, 3246 infants survived at discharge, 79 died after discharge, and 592 were lost to follow-up. Thus, 2575 of 3167 infants were seen in the follow-up clinics with a compliance rate of 81%. Logistic regression analysis showed that various demographic and clinical variables are associated with poor neurodevelopmental outcomes. After adjustment for these risk factor, significant association were found between PSB (mg/dL) and death or NDI (odds ratio: 1.068; 95% confidence interval [CI]: 1.03–1.11); PDI & lt;70 (R = 1.057; 95% CI: 1.00–1.12), and hearing impairment requiring hearing aids (odds ratio: 1138; 95% CI: 1.00–1.30). There was no significant association between PSB (mg/dL) and CP, MDI & lt;70, and NDI. Conclusions. PSB concentrations during the first 2 weeks of life are directly correlated with death or NDI, hearing impairment, and PDI & lt;70 in ELBW infants. The statistical association based on retrospective analysis of observational data and relatively small effect size should be interpreted with caution. Furthermore, because of the possibility of compounding effects of variables on outcome, the potential benefits of moderate hyperbilirubinemia and the potential adverse effects of phototherapy, a randomized, controlled trial of aggressive and conservative phototherapy is needed to address this controversial issue.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 2003
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  • 7
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 116, No. 6 ( 2005-12-01), p. 1367-1373
    Abstract: Objective. To compare multiple logistic regression and neural network models in predicting death for extremely low birth weight neonates at 5 time points with cumulative data sets, as follows: scenario A, limited prenatal data; scenario B, scenario A plus additional prenatal data; scenario C, scenario B plus data from the first 5 minutes after birth; scenario D, scenario C plus data from the first 24 hours after birth; scenario E, scenario D plus data from the first 1 week after birth. Methods. Data for all infants with birth weights of 401 to 1000 g who were born between January 1998 and April 2003 in 19 National Institute of Child Health and Human Development Neonatal Research Network centers were used (n = 8608). Twenty-eight variables were selected for analysis (3 for scenario A, 15 for scenario B, 20 for scenario C, 25 for scenario D, and 28 for scenario E) from those collected routinely. Data sets censored for prior death or missing data were created for each scenario and divided randomly into training (70%) and test (30%) data sets. Logistic regression and neural network models for predicting subsequent death were created with training data sets and evaluated with test data sets. The predictive abilities of the models were evaluated with the area under the curve of the receiver operating characteristic curves. Results. The data sets for scenarios A, B, and C were similar, and prediction was best with scenario C (area under the curve: 0.85 for regression; 0.84 for neural networks), compared with scenarios A and B. The logistic regression and neural network models performed similarly well for scenarios A, B, D, and E, but the regression model was superior for scenario C. Conclusions. Prediction of death is limited even with sophisticated statistical methods such as logistic regression and nonlinear modeling techniques such as neural networks. The difficulty of predicting death should be acknowledged in discussions with families and caregivers about decisions regarding initiation or continuation of care.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 2005
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  • 8
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 121, No. 2 ( 2008-02-01), p. 289-296
    Abstract: OBJECTIVE. We compared the development of adverse neurodevelopmental outcomes at corrected ages of 18 to 22 months for extremely low birth weight infants exposed prenatally to dexamethasone, betamethasone, or no steroid. METHODS. Study infants were extremely low birth weight (401–1000 g) infants who were in the care of National Institute of Child Health and Human Development Neonatal Research Network centers between January 1, 2002, and April 30, 2003; they were assessed neurodevelopmentally at corrected ages of 18 to 22 months. Outcomes were defined as Bayley Scales of Infant Development-II Mental Development Index of & lt;70, Bayley Scales of Infant Development-II Psychomotor Development Index of & lt;70, bilateral blindness, bilateral hearing aid use, cerebral palsy, and neurodevelopmental impairment. Neurodevelopmental impairment was defined as ≥1 of the aforementioned outcomes. RESULTS. A total of 1124 infants met entry criteria. There were no statistically significant associations between prenatal dexamethasone exposure and any follow-up outcome, compared with no prenatal steroid exposure. Prenatal betamethasone exposure was associated with reduced risks of hearing impairment and neurodevelopmental impairment and with increased likelihood of unimpaired status, compared with no prenatal steroid exposure. Compared with betamethasone, dexamethasone was associated with a trend for increased risk of Psychomotor Development Index of & lt;70, increased risk of hearing impairment, and decreased likelihood of unimpaired status. CONCLUSIONS. Prenatal betamethasone exposure was associated with increased likelihood of unimpaired neurodevelopmental status and reduced risk of hearing impairment at corrected ages of 18 to 22 months among extremely low birth weight infants, compared with prenatal dexamethasone exposure or no prenatal steroid exposure. Pending a randomized, clinical trial, it may be in the best interests of infants to receive betamethasone, rather than dexamethasone, when possible.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 2008
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  • 9
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 114, No. 5 ( 2004-11-01), p. 1305-1311
    Abstract: Objective. Bronchopulmonary dysplasia (BPD) is the endpoint of many intervention trials in neonatology, yet the outcome measure when based solely on oxygen administration may be confounded by differing criteria for oxygen administration between physicians. We previously reported a technique to standardize the definition of BPD between sites by using a timed room-air challenge in selected infants. We hypothesized that a physiologic definition of BPD would reduce the variation in observed rates of BPD among different neonatal centers. Methodology. A total of 1598 consecutive inborn premature infants (501–1249 g birth weight) who remained hospitalized at 36 weeks' postmenstrual age were prospectively assessed and assigned an outcome with both a clinical definition and physiologic definition of BPD. The clinical definition of BPD was oxygen supplementation at exactly 36 weeks' postmenstrual age. The physiologic definition of BPD was assigned at 36 ± 1 weeks' postmenstrual age and included 2 distinct subpopulations. First, neonates on positive pressure support or receiving & gt;30% supplemental oxygen with saturations between 90% and 96% were assigned the outcome BPD and not tested further. Second, those receiving ≤30% oxygen or effective oxygen & gt;30% with saturations & gt;96% underwent a room-air challenge with continuous observation and oxygen-saturation monitoring. Outcomes of the room-air challenge were “no BPD” (saturations ≥90% during weaning and in room air for 30 minutes) or “BPD” (saturation & lt;90%). At the conclusion of the room-air challenge, all infants were returned to their baseline oxygen levels. Safety (apnea, bradycardia, increased oxygen use) and outcomes of the physiologic definition versus the clinical definition were assessed. Results. A total of 560 (35.0%) neonates were diagnosed with BPD by the clinical definition of oxygen use at 36 weeks' postmenstrual age. The physiologic definition diagnosed BPD in 398 (25.0%) neonates in the cohort. All infants were safely studied. There were marked differences in the impact of the definition on BPD rates between centers (mean reduction: 10%; range: 0–44%). Sixteen centers had a decrease in their BPD rate, and 1 center had no change in their rate. Conclusions. The physiologic definition of BPD reduced the overall rate of BPD and reduced the variation among centers. Significant center differences in the impact of the physiologic definition were seen, and differences remained even with the use of this standardized definition. The magnitude of the change in BPD rate is comparable to the magnitude of treatment effects seen in some clinical trials in BPD. The physiologic definition of BPD facilitates the measurement of BPD as an outcome in clinical trials and the comparison between and within centers over time.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 2004
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  • 10
    In: Pediatrics, American Academy of Pediatrics (AAP), Vol. 118, No. 5 ( 2006-11-01), p. 2084-2093
    Abstract: OBJECTIVE. The goals were to identify predictor variables and to develop scoring systems and classification trees to predict death/disability or death in infants with hypoxic-ischemic encephalopathy. METHODS. Secondary analysis of data from the multicenter, randomized, controlled, National Institute of Child Health and Human Development Neonatal Research Network trial of hypothermia in hypoxic-ischemic encephalopathy was performed. Data for 205 neonates diagnosed as having hypoxic-ischemic encephalopathy were studied. Logistic regression analysis was performed by using clinical and laboratory variables available within 6 hours of birth, with death or moderate/severe disability at 18 to 22 months or death as the outcomes. By using the identified variables and odds ratios, scoring systems to predict death/disability or death were developed, weighting each predictor in proportion to its odds ratio. In addition, classification and regression tree analysis was performed, with recursive partitioning and automatic selection of optimal cutoff points for variables. Correct classification rates for the scoring systems, classification and regression tree models, and early neurologic examination were compared. RESULTS. Correct classification rates were 78% for death/disability and 71% for death with the scoring systems, 80% and 77%, respectively, with the classification and regression tree models, and 67% and 73% with severe encephalopathy in early neurologic examination. Correct classification rates were similar in the hypothermia and control groups. CONCLUSIONS. Among neonates diagnosed as having hypoxic-ischemic encephalopathy, the classification and regression tree model, but not the scoring system, was superior to early neurologic examination in predicting death/disability. The 3 models were comparable in predicting death. Only a few components of the early neurologic examination were associated with poor outcomes. These scoring systems and classification trees, if validated, may help in assessments of prognosis and may prove useful for risk-stratification of infants with hypoxic-ischemic encephalopathy for clinical trials.
    Type of Medium: Online Resource
    ISSN: 0031-4005 , 1098-4275
    Language: English
    Publisher: American Academy of Pediatrics (AAP)
    Publication Date: 2006
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