Two independent, investigator-blinded, multicenter, randomized clinical trials, one of which included microbiologic evaluation of middle-ear fluid obtained by use of tympanocentesis, compared the efficacy and safety of two oral antibiotics, cefuroxime axetil suspension and amoxicillin/clavulanate suspension, in the treatment of children 3 months to 12 years old diagnosed with acute otitis media with effusion (AOME). Four hundred seventy-seven pediatric patients with signs and symptoms of AOME were enrolled at 20 centers and were randomly assigned to receive 10 days of treatment with either cefuroxime axetil suspension 30 mg/kg per day in two divided doses (n = 235) or amoxicillin/clavulanate suspension 40 mg/kg per day in three divided doses (n = 242). Patients were assessed for their response to treatment once during treatment (at 3 to 5 days) and twice after treatment (at 1 to 4 days and at 14 to 18 days). In the study that included tympanocentesis, bacteriologic assessments were based on middle-ear fluid cultures obtained pretreatment, and, when possible, posttreatment in patients with an unsatisfactory clinical outcome. Organisms were isolated from the pretreatment middle-ear fluid specimens of 120 (73%) of 164 patients undergoing tympanocentesis, with the primary pathogens being Streptococcus pneumoniae. Haemophilus influenzae, and Moraxella catarrhalis (27%, 24%, and 6% of isolates, respectively). Forty-four percent of the H influenzae isolates and 94% of the M catarrhalis isolates that were tested for beta-lactamase production were positive. A satisfactory clinical outcome (cure or improvement) was obtained in 70% of clinically assessable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (P = 0.40). With respect to the eradication of bacterial pathogens, in the study that included tympanocentesis a satisfactory outcome (cure or presumed cure) was obtained in 84% (32 of 38) and 95% (36 of 38) of bacteriologically assessable patients treated with cefuroxime axetil or amoxicillin/clavulanate, respectively (P = 0.26). Treatment with amoxicillin/clavulanate was associated with a significantly higher incidence of drug-related adverse events than was treatment with cefuroxime axetil (37% vs 16%; P < 0.001), primarily reflecting a higher incidence of drug-related gastrointestinal adverse events (34% vs 12%; P < 0.001), particularly diarrhea. Eight patients in the cefuroxime axetil group and 11 patients in the amoxicillin/clavulanate group withdrew from the studies because of drug-related adverse events. These results indicate that cefuroxime axetil suspension 15 mg/kg twice daily is as effective as amoxicillin/clavulanate suspension 13.3 mg/kg three times daily in the treatment of pediatric patients with AOME, but produces fewer gastrointestinal adverse events, particularly diarrhea.

Amoxicillin↗

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The epidemiology of white full-term infants with short crown-heel lengths for gestational ages at birth.

Fetal growth retardation was diagnosed in 137 (7.8 percent) of 1,757 white full-term infants who had crown-heel lengths below the fifth percentiles for their gestational ages. The incidence of short infants was 121 (11.1 percent) among 1,093 mothers with high-risk pregnancies compared to 16 (2.4 percent) in 664 low-risk mothers (p less than 0.0001). There were four high-risk categories: spontaneous premature rupture of membranes (PROM), fetal conditions, complications of pregnancy, and adverse maternal practices. The incidence of short infants was significantly higher in each of the four high-risk categories than in the low-risk group. There were three other conditions that were present in all pregnancies that were associated with the frequency of short infants: maternal height, socioeconomic status of head of household, and sex of infant. A short maternal height (under 157.7 cm = 62 inches) was significantly associated with an increase in short infants among mothers who smoked cigarettes at any level during pregnancy and among mothers with PROM in combination with other risks, but not in the group of 664 low-risk mothers. Significantly more short girls than short boys were born to mothers who smoked ten or more cigarettes a day throughout pregnancy or who had multiple adverse maternal practices, but no statistically significant differences were noted among mothers who smoked fewer than ten cigarettes per day, among those with PROM as the only risk factor, or among those with medical or obstetrical complications. Moreover, those mothers who were in socioeconomic groups III and IV and had other risk factors had a significantly higher incidence of short infants than did similar mothers in socioeconomic groups I and II.

Body Height↗

PubMedDate not supplied

Epidemiology of spontaneous premature rupture of membranes: factors in pre-term births.

The frequency of spontaneous premature rupture of membranes (PROM) was determined in the pregnancies of 1,848 white mothers and their singleton infants, born at the University of Kansas Medical Center between April 1975 and April 1978. The frequency of PROM increased significantly from a low of 34/707 (4.8 percent) among low-risk mothers, to 40/444 (9.0 percent) among mothers smoking one to 60 cigarettes a day, to 21/204 (10.3 percent) among mothers with multiple adverse maternal practices, and to 12/46 (26 percent) among mothers with selected complications of their pregnancies. The proportion of low birth weight (LBW) (less than 2,500 g) pre-term infants born to PROM mothers increased among the risk factor groups in a similar manner, from a low of 2/34 (6 percent) in low-risk pregnancies to 8/40 (20 percent) among mothers smoking one to 60 cigarettes a day, to 7/21 (33 percent) among mothers with multiple adverse practices, and to 7/12 (58 percent) among mothers with selected complications of pregnancy. The increased incidence of low birth weight pre-term infants born to mothers with PROM was associated with evidence of growth retardation among full-term infants in the high-risk groups. This finding was manifested by reductions in mean birth weights of full-term infants born to high-risk mothers but not observed in full-term infants born to low-risk mothers. The attained growth at birth of low birth weight pre-term infants could not be determined, because appropriate birth weight standards for pre-term infants born to mothers with low-risk pregnancies are not available. These results suggest that growth retardation in fetuses increased the probability of the mothers having PROM prior to the onset of labor, and, if PROM did occur, of having a premature delivery. We hypothesize that the tensile strength of the amnion and chorion is diminished by the same conditions that retard fetal growth, and that this reduction in strength of the fetal membranes contributes to premature rupture of membranes and pre-term delivery.

Female↗

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Incidence of low birth weight infants born to mothers with multiple risk factors.

Low birth weight (LBW) is associated with a large number and variety of risk conditions during pregnancy. The number and types of risk conditions per pregnancy were determined in 1,864 white and 872 black mothers delivered at the University of Kansas Medical Center between 1975 and 1978. The incidence of LBW infants increased steadily among white and black mothers as the number of risk factors increased from none to three or four per pregnancy. Among pregnancies without spontaneous premature rupture of membranes (PROM), 51 percent of the LBW infants were born to mothers who had multiple risk factors associated with their pregnancies, even though only 18 percent of these pregnancies were associated with multiple risk factors. Among pregnancies with PROM, 72 percent were associated with multiple risk conditions, and 31 percent resulted in LBW infants. About 90 percent of LBW infants from PROM pregnancies had mothers with multiple risk factors. For all numbers of risk conditions, black mothers had a higher incidence of LBW infants than white mothers. Among black mothers without spontaneous premature rupture of membranes (PROM), the incidence of LBW infants increased from 3.2 percent (10/308) in low (zero)-risk condition pregnancies to 33 percent (16/49) among mothers with three or four risk conditions during the pregnancy. Among white mothers without PROM, the incidence of LBW infants increased from 1.7 percent (12/708) in low (zero)-risk condition pregnancies to 30 percent (19/64) in pregnancies with three or four risk conditions.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

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The effect of race on the incidence of low birth weight: persistence of effect after controlling for socioeconomic, educational, marital, and risk status.

The purpose of this study was to determine whether the elevated risk for low birth weight (LBW) infants among black mothers would persist when biologic, behavioral, and socioeconomic factors (as measured by socioeconomic status, level of education, and marital status) were controlled. It was found that the odds ratios for the risk of LBW for blacks/whites persisted above 1.5, regardless of what subgroups were used and what factors were controlled. The black/white odds ratios were, however, less than 2.0 when cigarette smoking was not a risk factor and higher than 2.0 when it was. In fact, the highest odds ratios, up to 2.65, occurred among the smoking group. These data suggest that smoking may have a more strongly negative effect among black than white pregnant mothers. In general, the effect of race on the LBW risk was much less strong than that of risk factors that can be influenced, such as adverse maternal practices.

Adolescent↗

PubMedDate not supplied

Phase I-II study of mitomycin C topical therapy for low-grade, low stage transitional cell carcinoma of the bladder: an interim report.

Intravesical mitomycin C therapy was administered to 63 patients with noninvasive bladder carcinoma in a phase I-II study. Doses ranged from 20 to 60 mg once a week for 8 weeks. The overall response rate was 67% including a complete remission rate of 45%. The median duration of complete remission for the two lowest dose groups was > 14 months, with a range of 1-36+ months. Followup is not yet adequate to determine the median duration of complete remission for the higher dose groups. No bone marrow suppression or other systemic toxic effects were noted. Adverse effects were localized and occurred infrequently. No mitomycin C was detected in serial serum samples after intravesical instillation.

Absorption↗