bluuebunny/crossref_metadata_2025_split huggingface dataset:
Determinants of Parental Authorization for Involvement of Newborn Infants in Clinical Trials
Authors: Zupancic John A. F. , Gillie Pat , Streiner David L. , Watts John L. , Schmidt Barbara 
Published: August 2004

Objective. Parents have the right to decide on behalf of their infants whether to enroll them in controlled clinical trials. We determined the degree to which such parental decisions are influenced by risk and benefit considerations compared with other factors.
Design. Cross-sectional survey.
Participants. Parents who had recently given or declined consent to one of three controlled trials in the neonatal intensive care unit.
Intervention. Parents were asked to complete a questionnaire that consisted of 15 sociodemographic items and 13 scaled responses to statements assessing the probability and magnitude of risk and benefit as well as perceived illness severity, attitudes toward research, and the consent process.
Analysis. Responses were subjected to factor analysis to identify underlying constructs. The sample was then randomly split, and multiple regression was performed on each half.
Results. The response rate was 83% (103 of 124) for those who had consented and 86% (37 of 43) for those who had declined. Factor analysis yielded three factors: (1) illness severity, (2) perceptions of risk or benefit and attitudes to research, and (3) sociodemographic characteristics. Multiple linear regression showed a significant multiple correlation of consent decision (r = .502), but only the second factor contributed. The analyses on split halves of the sample were comparable. Thirty-two percent of all parents agreed with the statement, “I would prefer to have the doctors advise me whether my baby should be in the study, rather than asking me to decide.”
Conclusions. In making consent decisions on behalf of their newborn infants, parents are influenced by risk and benefit assessments, attitudes toward research, and the integrity of the consent process. Illness severity or sociodemographic characteristics do not seem to be of similar importance. Rather than making the decision alone, a significant minority of parents would prefer to have the physicians advise them whether to volunteer their infants for a clinical trial. medical ethics, informed consent, newborn infant, clinical trial.
Anaphylaxis in Children: A 5-Year Experience
Authors: Dibs Susan D. , Baker M. Douglas 
Published: August 2004

Objectives. To identify the causative agents, presenting signs and symptoms, and course of disease in children diagnosed with anaphylaxis.
Design. Five-year retrospective chart review.
Setting. Urban children’s hospital pediatric emergency department, operating suite, and inpatient units.
Participants. Fifty-five cases of anaphylaxis in 50 patients 1 to 19 years of age.
Interventions. None.
Results. The most common inciting agents in this population were latex (27%), food (25%), drugs (16%), and venoms (15%). Thirty-two cases (58%) occurred outside of the hospital, including 3 of 11 severe cases. Nineteen (35%) had histories of prior allergy to the causative agent. Most agent exposures were intravenous (38%), oral (27%), or dermal (20%). The most common systems involved were respiratory (93%), skin (93%), cardiovascular (26%), and neurologic (26%). Features distinguishing the 11 patients requiring intensive care included latex agents (45%), nonenteral route of exposure (91%), and presence of cardiovascular symptoms (45%). Of the 17 patients with known past anaphylaxis, only 5 had epinephrine self-administration devices available, and 3 had used them.
Conclusions. (1) Most patients with anaphylaxis present with skin or respiratory symptoms. (2) Severely ill children more commonly have nonenteral and/or latex exposures that occur in the hospital. (3) Most children with anaphylaxis have no stated histories of prior reaction to the causative agent. (4) Those patients who have had past episodes of anaphylaxis infrequently have epinephrine self-administration devices available for use. anaphylaxis, allergy, latex.
Comparison of Inpatient Charges Between Academic and Nonacademic Services in a Children's Hospital
Authors: Wall Terry C. , Fargason Crayton A. , Johnson Victoria A. 
Published: August 2004

Objective. To compare inpatient hospital charges generated within a children's hospital by academic and nonacademic pediatric services for common medical diagnoses.
Methods. Hospital admissions to a free-standing children's hospital between 9/1/90 and 8/30/94 were selected for patients who were hospitalized 1 to 14 days, with one of six selected diagnoses, and with discharge attending of record either a private pediatrician or an academic subspecialist. Discharge diagnoses, based on ICD-9 codes, included asthma (n = 1983), bronchiolitis (n = 692), gastroenteritis (n = 733), rule out sepsis (n = 1065), urinary tract infection (n = 516), and viral meningitis (n = 288). Charges associated with patient records were dichotomized as above or below the median charge for each diagnostic category. Each category was analyzed separately using a logistic regression model where the dichotomous-dependent variable was charges above the median charge for each diagnosis. Independent variables included physician type, payor status, patient residence, ICD-9 code as primary or secondary diagnosis, patient age, and presence of complicating conditions.
Results. By univariate comparison, academic physicians cared for a higher percentage of underinsured patients, and their care was more expensive. Complicated claims were associated with higher charges than uncomplicated claims for all diagnostic categories. Academic and nonacademic physicians were equally likely to generate above-median charges for five of the six diagnostic categories when controlling for confounding factors. A linear regression model in which charge was the dependent variable generated similar results.
Conclusions. Within the same pediatric health care facility, no consistent difference was found between charges incurred on academic vs private inpatient services.
How Fetal Cocaine Exposure Increases Neonatal Hospital Costs
Authors: Behnke Marylou , Eyler Fonda Davis , Conlon Michael , Casanova Olga Quiros , Woods Nanci Stewart 
Published: August 2004

Objective. Our goals were to document hospital costs associated with prenatal cocaine exposure in an understudied population—women using rural county public health units who had minimal access to drug rehabilitation and whose cocaine of choice was crack with little other illicit drug use—and to explore why increased costs occur in an effort to identify cost-reduction strategies.
Methods. We identified a sample of cocaine-exposed infants who were computer-matched to a control group with no history or evidence of cocaine exposure. Matching was performed one-to-one on the variables of maternal race, age, parity, time of entry into prenatal care, and alcohol and nicotine use. There were 327 live births, for whom 311 were correctly classified as to their prenatal cocaine use and had billing and medical records available for review (156 exposed, 155 nonexposed).
Results. Hospital charges were positively correlated with length of stay. Cocaine-exposed infants had an across-the-board increase in utilization of hospital resources as well as higher hospital charges and longer lengths of stay. Cocaine-exposed infants were significantly younger in gestational age and lower in birth weight. Significantly more cocaine-exposed infants were admitted to the neonatal intensive care unit, had more social and family problems delaying discharge, and received more septic work-ups. In addition, of those infants urine-screened for cocaine at delivery, 92% were screened secondary to a maternal history of prenatal use.
Conclusions. Cost-reduction strategies should be aimed at measures that reduce length of stay by addressing problems identified prenatally as an outpatient before delivery and by influencing objective decision-making regarding the need for medical interventions with the infant after birth.
Pilot Interferon-β Trial in Children With Chronic Hepatitis B Who Had Previously Not Responded to Interferon-α Therapy
Authors: Ruı́z-Moreno Mercedes , Fernández Patricia , Leal Ana , Bartolomé Javier , Castillo Inmaculada , Oliva Horacio , Carreño Vicente 
Published: August 2004

Background. Recombinant interferon α (IFN-α) treatment is useful in 40% of children with chronic hepatitis B. However, nonresponder children continue to have viral replication and a progressive disease.
Objective. To administer natural IFN-β to hepatitis B virus chronic carrier children who had not responded to a previous IFN-α cycle.
Methods. Twenty-two children with chronic hepatitis B, nonresponders to a previous IFN-α cycle, were retreated with 5 MU/m2 of body surface of natural IFN-β, administered intramuscularly, three times per week for 24 weeks.
Results. At the end of treatment, 9 (41%) of 22 children became hepatitis B virus DNA negative. Hepatitis B e antibodies (anti-HBe) developed in 5 of these children, and 6 had normal alanine aminotransferase values. At the end of the posttreatment follow-up (21 months from the beginning of the study), 10 (45%) of 22 children were viral DNA negative, 7 (32%) of 22 were anti-HBe positive (none of them had viral DNA in serum), and 11 (50%) of 22 had normal alanine aminotransferase levels (10 without detectable viral DNA and 7 anti-HBe positive).
Conclusion. IFN-β seems to be an effective retreatment therapy for children with chronic hepatitis B who are nonresponders to a first IFN-α cycle; however, a controlled study should be performed to confirm these results.
Effect of Corticosteroids on Intracranial Pressure, Computed Tomographic Findings, and Clinical Outcome in Young Children With Tuberculous Meningitis
Authors: Schoeman Johan F. , Van Zyl Lana E. , Laubscher Jacoba A. , Donald Peter R. 
Published: August 2004

Objective. To study the effect of high-dose prednisone on intracranial pressure (ICP), cranial computed tomographic (CT) findings, and clinical outcome in young children with moderate to severe tuberculous meningitis (TBM).
Study Design. Prospective, controlled, randomized study.
Methods. Continuous lumbar cerebrospinal fluid pressure monitoring and contrasted CT scanning were performed in 141 consecutive children with TBM at admission. All children were then randomly allocated to a nonsteroid group (71 children) or a steroid group (70 children) who received prednisone (first 16 children, 2 mg/kg per day; next 54 children, 4 mg/kg per day) for the first month of treatment. ICP monitoring and CT scanning were repeated regularly, and clinical outcome was assessed after 6 months of antituberculosis treatment.
Results. No statistically significant difference in ICP or the degree of hydrocephalus (as demonstrated by CT scan) was found between the steroid and nonsteroid groups after the first month of treatment. Basal ganglia infarcts developed in 16% of children in the steroid group and 24% in the nonsteroid group during the first month of treatment. Neither this incidence nor the eventual size of infarcts present at admission differed significantly between the two treatment groups. Single or multiple tuberculomas were seen on the first CT scans of 7 children (5%), whereas tuberculomas developed in 11 children (8%) at treatment. Both the response of the tuberculomas to treatment and the incidence of new tuberculomas were significantly improved by steroid therapy. Basal enhancement was also significantly less in the steroid group after 1 month of treatment. Steroids lowered mortality in stage III TBM significantly. Similarly, more surviving children in the steroid group had IQs of greater than 75 than did the those in the nonsteroid group. No significant difference was found in the incidence of motor deficit, blindness, or deafness.
Conclusions. Corticosteroids significantly improved the survival rate and intellectual outcome of children with TBM. Enhanced resolution of the basal exudate and tuberculomas by steroids was shown by serial CT scanning. Corticosteroids did not affect ICP or the incidence of basal ganglia infarction significantly.
“Inactive” Ingredients in Pharmaceutical Products: Update (Subject Review)
Authors:   Committee on Drugs
Published: August 2004

This Clinical Report was retired January 2004.
Because of an increasing number of reports of adverse reactions associated with pharmaceutical excipients, in 1985 the Committee on Drugs issued a position statement1recommending that the Food and Drug Administration mandate labeling of over-the-counter and prescription formulations to include a qualitative list of inactive ingredients. However, labeling of inactive ingredients remains voluntary. Adverse reactions continue to be reported, although some are no longer considered clinically significant, and other new reactions have emerged. The original statement, therefore, has been updated and its information expanded.
The Impact of Asthma on the Health Status of Adolescents
Authors: Forrest Christopher B. , Starfield Barbara , Riley Anne W. , Kang Myungsa 
Published: August 2004

Objective. To identify a characteristic pattern of health and illness for adolescents with asthma, we compared the health status of teenagers with asthma to those without asthma using a recently developed generic health status instrument, the Child Health and Illness Profile, Adolescent Edition (CHIP-AE).Methods. This was a cross-sectional survey using a school sample of 3109 teenagers. Participants completed the CHIP-AE during school in northern Baltimore City, rural western Maryland, and rural Arkansas. The health and functioning scores of teens without asthma (“well” group) were compared with those with asthma with and without recent wheezing.Results. Of the 12% who reported that a physician had ever told them they had asthma, 50% had problems with wheezing in the past 28 days. Compared with well teenagers, those with asthma and recent wheezing had lower perceived well-being, more physical and emotional symptoms, greater limitations in activity, more comorbidities, and more negative behaviors that threaten social development. These findings held true in multivariable regression models that controlled for sociodemographics and sites of data collection. Teenagers with asthma without recent wheezing reported a greater number of comorbidities than well teens and showed similar trends in health status as those with recently symptomatic asthma.Conclusions. Multiple aspects of adolescent health status are affected by asthma, particularly if it is recently symptomatic. These results argue for incorporating a generic health status instrument, such as the CHIP-AE, in studies that document the health needs or outcomes of medical care for populations of teenagers with asthma. asthma, quality of life, adolescence.
Survey of the Use of Peripherally Inserted Central Venous Catheters in Children
Authors: Thiagarajan Ravi R. , Ramamoorthy Chandra , Gettmann Theresa , Bratton Susan L. 
Published: August 2004

Objective. Use of peripherally inserted central venous catheters (PICCs) to provide prolonged intravenous (IV) access in children is increasing. Our goal was to describe the children treated with PICCs in our institution, and to study catheter features such as catheter life, completion of therapy, and complications. Furthermore, we also evaluated PICC use in children completing therapy after discharge from our institution.
Methods. A prospective study of all PICCs inserted at the Children’s Hospital and Medical Center (CHMC), a university-affiliated teaching institution, during a period of 18 months (January 1994 to July 1995).
Results. A total of 441 PICCs were inserted in 390 patients. Patient age ranged from 0 to 22 years with a mean of 5.4 ± 6.0 years. No insertion complications occurred. Treatment of infectious disease (46%) was the most frequent reason for PICC insertion. All pediatric medical and surgical services used PICCs. Average catheter life was 13 ± 12 days. Sixty-one percent of PICCs were used entirely at CHMC, while 39% were also used at home or at an outside hospital. Completion of therapy was achieved in 69% of PICCs. Among children who completed therapy outside our hospital, there was no difference in the rates of occlusion, accidental dislodgment, or infection.
One hundred twenty-nine (29%) PICCs were removed for complications. Occlusion (7%), accidental displacement (8%), and suspicion of sepsis (8%) were the most common complications. Only 2% of PICCs had documented catheter-associated sepsis.
Conclusions. PICCs provide reliable and safe access for prolonged IV therapy in neonates and children. The low incidence of complications with PICCs make them an attractive device for prolonged IV access. Similar complication rates with use in and out of hospital suggest that home IV therapy can be safely delivered with PICCs, avoiding expensive hospitalization. peripherally inserted central venous catheter, vascular access, catheter related sepsis, completion of therapy, occlusion, accidental dislodgment, home therapy, phlebitis.
Effect of Otitis Media With Effusion on Gross Motor Ability in Preschool-aged Children: Preliminary Findings
Authors: Orlin Margo N. , Effgen Susan K. , Handler Steven D. 
Published: August 2004

Objective. To investigate whether gross motor skills in preschool-aged children 24 to 60 months old with otitis media with effusion (OME) are different from those of preschool children without OME.Children and Methods. The gross motor portion of the Peabody Developmental Motor Scales (PDMS-GM) was used to compare 13 children with OME before and after tympanostomy tube placement to 12 children without OME.Results. The children with OME had significantly reduced scores preoperatively compared to those without OME on the PDMS-GM. After surgery, the children with OME had higher scores than those without OME, indicating an accelerated rate of development.Conclusions. Balance and motor development are additional factors to be considered in the medical and surgical management of the young child with chronic OME. Chronic OME may represent an additional problem for young children with existing motor deficits or other disabilities.
Psychiatric Disorders in Adult Patients With Early-treated Phenylketonuria
Authors: Pietz Joachim , Fätkenheuer Brigitte , PhD Peter Burgard , Armbruster Meinrad , Esser Günther , Schmidt Hildgund 
Published: August 2004

Objective. To determine psychiatric disorders in patients with phenylketonuria (PKU) and to test whether biochemical control, intellectual functioning, white matter abnormalities visible on magnetic resonance imaging (MRI), and/or style of parenting influence psychopathology.
Design and Subjects. This cross-sectional study consisted of 35 PKU patients 17 to 33 years of age (mean: 22.2). From a total of 67 patients, 3 patients were selected because of other causes of possible brain damage. Then 35 patients were randomly drawn with comparison with a control sample (n = 181) from an epidemiologic study.
Methods. We used a standardized, highly structured, face-to-face interview; intelligence quotient (IQ) test; cranial MRI (n = 26); and monitoring of plasma phenylalanine.
Results. The overall rate of psychiatric disorders was 25.7% in PKU patients and 16.1% in controls. This difference was not statistically significant. The pattern of psychiatric disturbances was different for PKU patients and controls (Fisher's exact test): in PKU patients, externalizing disorders were reduced (PKU: not present, controls: 7.8%), whereas internalizing disorders (PKU: 25.7%, controls: 8.3%) were increased. International Classification of Diseases, version 10, diagnoses were predominantly those of the depressive category and more frequent in women (8 of 18 females and 1 of 17 males). A correlation between IQ and both biochemical control up to 12 years of age and school education of parents was confirmed. No correlation was found between the severity or pattern of psychiatric disturbances and school education of parents, biochemical control, IQ, or the extension of MRI-visible, white matter abnormalities. It was found that a restrictive controlling style of parenting is a risk factor for the development of psychiatric symptoms.
Conclusions. Our results support a psychological perspective for the development of psychiatric symptoms in PKU. Thus, optimizing medical treatment necessary to prevent brain damage should be accompanied by psychiatric monitoring and psychological support for the families.
High-dose Epinephrine Is Not Superior to Standard-dose Epinephrine in Pediatric In-hospital Cardiopulmonary Arrest
Authors: Carpenter Todd C. , Stenmark Kurt R. 
Published: August 2004

Objective. To compare the efficacy of high-dose epinephrine (HDE) with that of standard-dose epinephrine (SDE) for resuscitation from in-hospital pediatric cardiopulmonary arrest (CPA).Design. Fifty-four-month retrospective study of all pediatric patients who had a CPA while hospitalized at a tertiary care children's hospital. Standard pediatric advanced life support techniques were used for all patients. Patients received HDE or SDE in accordance with physician orders and standard protocols at the time of CPA. Primary outcome measures were the return of spontaneous circulation (ROSC), the duration of survival after resuscitation, survival to hospital discharge, and Pediatric Overall Performance Category scores at the time of discharge.Results. During the study period, 51 patients met entry criteria and had a total of 58 CPAs. Twenty-one patients received HDE during resuscitation from 24 arrests, at a dose of 0.12 ± 0.05 mg/kg (mean ± SD); 30 patients received SDE during resuscitation from 34 arrests, at a dose of 0.01 ± 0.01 mg/kg (mean ± SD). The HDE and SDE groups were not significantly different in terms of gender, initial cardiac rhythm, location of CPA, primary diagnoses at the time of CPA, initial pH, or additional resuscitation medications received; the SDE group had a significantly higher mean age, although the median ages were not different. Fourteen of 24 resuscitations using HDE resulted in ROSC (58%) with a mean time to ROSC of 19 minutes; 7 (29%) of 24 led to survival for 24 hours, and 6 (26%) of 23 patients survived to hospital discharge, all with moderate to severe neurologic and functional impairment. Twenty-four of 34 resuscitations using SDE resulted in ROSC (71%) with a mean time to ROSC of 12 minutes; 17 (50%) of 34 led to survival for 24 hours; and 7 (23%) of 30 patients survived to hospital discharge, 4 with mild to moderate neurologic impairment. No significant differences in rates of ROSC, survival rates, or Pediatric Overall Performance Category scores of survivors were found between the two groups. The mean time to ROSC was significantly longer in the HDE group.Conclusions. In this study, the use of HDE did not improve the rates of ROSC, short-term survival, or long-term survival after pediatric in-hospital CPA, nor did it improve overall outcome scores. Given the conflicting evidence surrounding possible detrimental effects of HDE use, a large, blinded, prospective trial of HDE use in this setting is necessary to clarify the appropriate role for HDE in pediatric resuscitation.