Objective. To determine the safety and efficacy of prophylaxis with palivizumab in reducing the incidence of hospitalization because of respiratory syncytial virus (RSV) infection in high-risk infants. Methods. A randomized, double-blind, placebo-controlled trial was conducted at 139 centers in the United States, the United Kingdom, and Canada. During the 1996 to 1997 RSV season, 1502 children with prematurity (less than or equal to 35 weeks) or bronchopulmonary dysplasia (BPD) were randomized to receive 5 injections of either palivizumab (15 mg/kg) or an equivalent volume of placebo by intramuscular injection every 30 days. The primary endpoint was hospitalization with confirmed RSV infection. Children were followed for 150 days (30 days from the last injection). Those with hospitalization as a result of RSV infection were evaluated for total number of days in the hospital, total days with increased supplemental oxygen, total days with moderate or severe lower respiratory tract illness, and incidence and total days of intensive care and mechanical ventilation. The incidence of hospitalization for respiratory illness not caused by RSV and the incidence of otitis media were also evaluated. The placebo and palivizumab groups were balanced at entry for demographics and RSV risk factors. Ninety-nine percent of children in both groups completed the protocol and similar to 93% received all five scheduled injections. Results. Palivizumab prophylaxis resulted in a 55% reduction in hospitalization as a result of RSV (10.6% placebo vs 4.8% palivizumab). Children with prematurity but without BPD had a 78% reduction in RSV hospitalization (8.1% vs 1.8%); children with BPD had a 39% reduction (12.8% vs 7.9%). When gender, entry age, entry weight, BPD, and gestational age were included in a logistic regression model, the effect of prophylaxis with palivizumab remained statistically significant. The palivizumab group had proportionally fewer total RSV hospital days, fewer RSV hospital days with increased oxygen, fewer RSV hospital days with a moderate/severe lower respiratory tract illness, and a lower incidence of intensive care unit admission. Palivizumab was safe and well tolerated. No significant differences were observed in reported adverse events between the two groups. Few children discontinued injections for related adverse events (0.3%). Reactions at the site of injection were uncommon (1.8% placebo vs 2.7% palivizumab); the most frequent reaction was mild and transient erythema. Mild or moderate elevations of aspartate aminotransferase occurred in 1.6% of placebo recipients and 3.6% of palivizumab recipients; for alanine aminotransferase these percentages were 2.0% and 2.3%, respectively. Hepatic and renal adverse events related to the study drug were similar in the two groups. Conclusions. Monthly intramuscular administration of palivizumab is safe and effective for prevention of serious RSV illness in premature children and those with BFD.

Objective. To determine the safety and efficacy of monthly prophylaxis with respiratory syncytial virus immune globulin, intravenous (RSV-IGIV) for reduction of the incidence of RSV-associated hospitalization.Methods. A randomized, double-blind, placebo-controlled clinical trial was conducted at 54 centers in the United States during the 1994 to 1995 RSV season. A total of 510 children with bronchopulmonary dyspIasia and/or a history of prematurity were randomized to receive either 750 mg/kg RSV-IGIV (n = 250) or placebo (1% albumin; n = 260) intravenously every 30 days. Randomized groups were well balanced at entry for demographics, RSV risk factors, and birth characteristics. Children were monitored for adverse events and for RSV-associated hospitalization from randomization through 30 days after the last infusion visit; serious adverse events were monitored for an additional 30 days. For children hospitalized with RSV, data were collected regarding the total days of RSV stay, total days of increased oxygen requirement, total days with a moderate or severe lower respiratory tract illness, and frequency and duration of intensive care unit stay and mechanical ventilation. Ninety-five percent of participants completed the protocol and 85% received a complete course of infusions.Results. The incidence of RSV hospitalization was reduced by 41% in children receiving RSV-IGIV prophylaxis; 35 (13.5%) of the children in the placebo group were hospitalized for RSV, compared with 20 (8.0%) RSV-IGIV recipients. RSV-IGIV recipients had a 53% reduction in the total number of RSV hospital days per 100 children, a 60% reduction in the number of RSV days with increased oxygen requirement, and a 54% reduction in the number of RSV hospital days with a moderate or severe lower respiratory tract illness. In addition, children receiving RSV-IGIV had a 38% reduction in hospitalization for respiratory illness of any cause and a 46% reduction in total hospital days for respiratory illness per 100 children. RSV-IGIV was safe and well tolerated, with a safety profile similar to other IGIV preparations. Between 1% to 3% of children had medically significant adverse events related to RSV-IGIV administration.Conclusions. Monthly administration of 750 mg/kg of RSV-IGIV was safe and well tolerated and was effective in reducing the incidence and total days of both RSV hospitalization and overall respiratory hospitalization in infants with a history of prematurity or bronchopulmonary dysplasia or both.

A national surveillance program for congenital cytomegalovirus (CMV) disease was initiated in 1990. In 4 years 285 cases were reported without seasonal patterns. Mean birth statistics were as follows: gestational age, 36 weeks; weight, 2,224 g; length, 45 cm; and head circumference, 30 cm. Of the infants 68% had CNS involvement, which was significantly (P < .005) associated with a direct bilirubin level of > or = 3 mg/dL, petechiae, an alanine aminotransferase level of > 100 U/L, a platelet count of < or = 75,000/mm3, hepatomegaly, and splenomegaly (P < .05). Maternal demographics revealed that the mean age was 23 years (range, 13-38 years), 59% were white, 33% were black, 47% had low incomes (receiving Medicaid), and 45% were primiparous. Compared with 1990 birth statistics in the United States, mothers of infants with congenital CMV disease were younger, and a greater percentage of these mothers were black. Two distinct maternal groups were identified on the basis of age, socioeconomic status, and parity. This finding may reflect different modes of transmission and suggest target populations for future CMV vaccine initiatives.

6. Malagelada.J-R, Camilleri M, Stanghellini V. Manometric diagnosis of gastrointestinal motility disorders. New York: Theime, 1986:57. 7. McLain CR. Amniography studies of the gastrointestinal motility in human fetus. Am J Obstet Gynecol 1963;86:1079-87. 8. Bueno L, Ruckebusch Y. Perinatal development of intestinal myoelectrie activity in dogs and sheep. Am J Physiol 1979; 237:E61-7. 9. Bisset WM, Watt JB, Rivers RPA, Milla PJ. The motor response of the small intestine to milk feeds in preterm infants [Abstract ]. Dig Dis Sci t987;32:903. 10. lttman PI, Berseth CL Antral motility response to duodenal feeding in preterrn and term infants [Abstract]. Pediatr Res 1989;25:116A. l l. Bisset WM, Watt JB, Rivers RPA, Milla PJ. Ontogeny of fasting small intestinal motor activity in the human infant. Gut 1988;29:453-88. 12. Morriss FH, Moore M, Weisbrodt NW, West MS. Ontogenic development of gastrointestinal motility. IV. Duodenal contractions in preterm infants. Pediatrics 1986;78: I 106-13. 13. Dunn L, Hulman S, Weiner J, Kleigman R. Beneficial effects of early hypocaloric enteral feeding on neonatal gastrointestinal function: preliminary report of a randomized trial. J PEDIATR 1988;112:622-9. 14. Kerlin P, Zinsmeister A, Phillips S. Relationship of motility to flow of contents in the human small intestine. Gastroenterology 1982;82:701-6.

With the availability of ribavirin therapy for serious respiratory syncytial virus (RSV) infections, rapid diagnostic tests for the detection of RSV antigen are increasingly important. Efficacies of a commercially available enzyme immunoassay (EIA) (Abbott Laboratories, North Chicago, Ill.) and a fluorescent-antibody assay (FA) were evaluated in a study involving 135 specimens from children with respiratory symptoms. A nasal wash specimen was cultured immediately on RSV-sensitive A549 cells; the nasal wash was also used for EIA. FA was performed on a nasopharyngeal swab specimen with bovine anti-RSV and anti-bovine immunoglobulin G antisera (Burroughs Wellcome Co., Research Triangle Park, N.C.). A total of 39 specimens (28%) were tissue culture positive, including 35 EIA-positive and 37 FA-positive samples (sensitivities, 90 and 95%, respectively). All 96 tissue culture-negative specimens were EIA negative (specificity, 100%); 94 of these 96 specimens were FA negative (specificity, 98%). Positive and negative predictive values for the tests were as follows: 100 and 96% for EIA, respectively, and 95 and 98% for FA, respectively. Other viruses, including influenza A virus, adenovirus, enterovirus, and herpes simplex virus, were isolated in nine cases. One adenovirus-positive specimen had a false-positive RSV FA result; all nine specimens were RSV EIA negative. Both tests performed well in our study and provide cost-effective alternatives to tissue culture. The RSV EIA, in particular, uses standard serologic techniques and equipment and does not require expertise in virology. More widespread availability of rapid diagnostic tests for RSV will hopefully result in early and appropriate use of antiviral therapy in patients at risk for serious RSV infections.

The model of recurrent herpes labialis was selected to evaluate the role played by stress in increasing susceptibility to illness. Initially, 35 paid volunteers with recurrent herpes were enrolled in the project. Compared with 35 age- and sex-matched controls, this group demonstrated a familial predisposition for recurrent herpes labialis. Eighteen subjects without confounding variables known to precipitate recurrent herpes infections completed a pretested "stress" questionnaire during a dormant and again during an active stage of infection. In the week prior to the appearance of a recurrence, this group experienced increased daily hassles, increased stressful life events, and higher state anxiety. These findings are discussed in the broader context of stress-associated disease with some speculations concerning a possible biologic mechanism, which involves modulations of T-lymphocyte function.

Journal Article Cytomegaloviral Infection and Disease Get access Janet S. Kinney, Janet S. Kinney Search for other works by this author on: Oxford Academic PubMed Google Scholar Ida M. Onorato, Ida M. Onorato Search for other works by this author on: Oxford Academic PubMed Google Scholar John A. Stewart, John A. Stewart Search for other works by this author on: Oxford Academic PubMed Google Scholar Robert F. Pass, Robert F. Pass Search for other works by this author on: Oxford Academic PubMed Google Scholar Sergio Stagno, Sergio Stagno Search for other works by this author on: Oxford Academic PubMed Google Scholar Sarah H. Cheeseman, Sarah H. Cheeseman Search for other works by this author on: Oxford Academic PubMed Google Scholar James Chin, James Chin Search for other works by this author on: Oxford Academic PubMed Google Scholar Mary L. Kumar, Mary L. Kumar Search for other works by this author on: Oxford Academic PubMed Google Scholar Anne S. Yaeger, Anne S. Yaeger Search for other works by this author on: Oxford Academic PubMed Google Scholar Kenneth L. Herrmann, Kenneth L. Herrmann Search for other works by this author on: Oxford Academic PubMed Google Scholar ... Show more Eugene S. Hurwitz, Eugene S. Hurwitz Search for other works by this author on: Oxford Academic PubMed Google Scholar Lawrence B. Schonberger Lawrence B. Schonberger Search for other works by this author on: Oxford Academic PubMed Google Scholar The Journal of Infectious Diseases, Volume 151, Issue 5, May 1985, Pages 772–774, https://doi.org/10.1093/infdis/151.5.772 Published: 01 May 1985

An animal model permitting study of congenital infections with cytomegalovirus (CMV) has been developed in guinea pigs. Fifteen Hartley strain guinea pigs in the latter half of pregnancy were inoculated intraperitoneally with 10(5.5) 50% tissue culture infective doses of guinea pig CMV. Forty percent of infected mothers delivered litters containing at least one infected newborn, as defined by a positive culture of lung, spleen, or brain. All tissues were cultured by an explant technique. The three mothers who had no detectable complement-fixing antibody to CMV prior to experimental infection delivered infected litters, whereas three of 12 immune mothers delivered infected litters (P less than 0.01). A low-passage, tissue culture-adapted virus produced neonatal infection as frequently as did salivary gland-passaged virus. No congenital abnormalities were found in any of the seven infected newborns. CMV was isolated from lung, spleen, or brain in the four newborns of nonimmune mothers; CMV was isolated from lung only in the three newborns of immune mothers. These preliminary experiments demonstrate that the guinea pig is a suitable animal for further study of maternal-fetal CMV infections.