Increased transient tachypnea of the newborn in infants of asthmatic mothers.

OBJECTIVE: To compare the incidence of transient tachypnea of the newborn (TTN) in infants of asthmatic vs nonasthmatic mothers. RESEARCH DESIGN: Case-control analysis. SETTING: Group model health maintenance organization. PATIENTS: A volunteer sample of 294 pregnant asthmatic women and 294 pregnant nonasthmatic women with normal pulmonary function test results, matched on the basis of age and smoking status. All subjects entered the study before their third trimester of pregnancy. Subjects with multiple gestations and abortions (less than 20 weeks' gestation) were excluded. INTERVENTION: Asthma was treated in the allergy department. Routine obstetric, neonatal, and pediatric care was provided to all patients by staff physicians. MEASUREMENTS/RESULTS: Transient tachypnea occurred in 11 infants (3.7%) of asthmatic women and in one control infant (0.3%). There were no significant differences between asthmatic and matched control subjects in previously defined TTN risk factors, such as the occurrence of longer labors, failure to progress, cesarean sections, premature births, male sex, Apgar scores of less than 7 at 1 minute, or birth weight greater than 4 kg. Although infants of asthmatic mothers were more likely to exhibit wheezing by age 15 months compared with control infants (12.0% vs 3.2%), none of the infants with TTN manifested wheezing by age 15 months. No relationships could be identified in the asthmatic cohort between the occurrence of TTN and asthma severity or medication use (during the pregnancy in general or during labor and delivery in particular). CONCLUSION: Although the mechanism is uncertain, maternal asthma appears to increase the risk of infant TTN.

Issues in the design of drug trials for AIDS.

Although the fundamental principles that drive the design, conduct, and analysis of clinical trials are as applicable to AIDS as to other diseases, there is no question that we have been confronted with unusually difficult challenges in studying therapeutic approaches in this disease area. Treatments are being developed that show great promise, but when investigated further some may be seen to offer no clinical benefit and others may do active harm through toxicity. A group of biostatisticians, meeting in association with the AIDS Clinical Trials Group (ACTG), has discussed and written a report on a number of issues, primarily related to principles of study design, with the goal of stimulating thought on new study designs and the timely implementation of well-designed trials to identify effective treatment strategies for HIV-infected populations. These issues include (1) progression of clinical trials through phases, (2) choices of outcomes, (3) breadth and complexity of clinical trials (eligibility criteria and "low-tech" trials, (4) alternative designs to be used in randomized trials, and (5) the concept of randomized clinical trials as a desirable option, both for patients and for science. The current HIV epidemic makes the requirements of obtaining valid scientific comparisons more important, not less so, but the challenge is to expedite this process.

Effect of combined maternal and infant food-allergen avoidance on development of atopy in early infancy: a randomized study.

The effect of maternal and infant avoidance of allergenic foods on food allergy was examined in a prenatally randomized, controlled trial of infants of atopic parents. The diet of the prophylactic-treated group (N = 103) included (1) maternal avoidance of cow's milk, egg, and peanut during the third trimester of pregnancy and lactation and (2) infant use of casein hydrolysate (Nutramigen) for supplementation or weaning, and avoidance of solid foods for 6 months; cow's milk, corn, soy, citrus, and wheat, for 12 months; and egg, peanut, and fish, for 24 months. In the control group (N = 185), mothers had unrestricted diets, and infants followed American Academy of Pediatrics feeding guidelines. The cumulative prevalence of atopy was lower at 12 months in the prophylactic-treated (16.2%) compared to the control (27.1%) group (p = 0.039), resulting from reduced food-associated atopic dermatitis, urticaria and/or gastrointestinal disease by 12 months (5.1% versus 16.4%; p = 0.007), and any positive food skin test by 24 months (16.5% versus 29.4%; p = 0.019), caused primarily by fewer positive milk skin tests (1% versus 12.4%; p = 0.001). The prevalences of allergic rhinitis, asthma, and inhalant skin tests were unaffected. Serum IgE levels in the prophylactic-treated group were marginally lower only at 4 months. Thus, reduced exposure of infants to allergenic foods appeared to reduce food sensitization and allergy primarily during the first year of life.

The safety of inhaled beta-agonist bronchodilators during pregnancy.

To assess the safety of inhaled beta-agonist bronchodilators during pregnancy, perinatal outcomes in 259 prospectively managed women with asthma using these medications during pregnancy were compared to perinatal outcomes in 101 concurrently followed pregnant subjects with asthma not using inhaled bronchodilators and to perinatal outcomes in 295 concurrently followed pregnant control subjects without asthma. No significant differences between women with asthma using inhaled bronchodilators and subjects not receiving inhaled bronchodilators were found in the following parameters: perinatal mortality, congenital malformations, preterm births, low birth weight infants, mean birth weight, small for gestational age or low ponderal index infants, Apgar scores, labor/delivery complications, or postpartum bleeding. Increased incidences of maternal chronic and pregnancy-induced hypertension and transient tachypnea of the neonate were observed in the pregnancies of subjects with asthma using regular inhaled bronchodilators compared to control subjects, but a logistic regression analysis within the sample of subjects with asthma did not significantly associate the use of inhaled bronchodilators with these outcomes. In the light of the known substantial perinatal risks of severe, uncontrolled asthma and the relatively sparse evidence of human gestational safety for alternative asthma medications, these data support the use of inhaled beta-agonist bronchodilators as part of the management of asthma during pregnancy.

Treatment of diabetic diarrhea and orthostatic hypotension with somatostatin analogue SMS 201-995.

A diabetic patient was treated with a somatostatin analogue, SMS 201-995, to control chronic diarrhea and orthostatic hypotension. The patient was injected with 50 micrograms, 100 micrograms, and 150 micrograms of SMS 201-995 subcutaneously twice daily for three days at each dose. Stool weight decreased from a basal mean value of 906 g per 24 hours to 628 g, 445 g, and 408 g per 24 hours, respectively. Diarrhea remained suppressed for 18 months when the patient was last seen. When SMS 201-995 was then given at 5 micrograms to 10 micrograms per hour by continuous subcutaneous infusion, stool weight decreased to a mean of 321 g per 24 hours. Basal blood pressure, which averaged 99/71 mm Hg, rose to 133/91 mm Hg five minutes after 75 micrograms of SMS 201-995 was injected subcutaneously; it remained elevated for six hours after injection. Serum motilin levels decreased significantly from 126 pg/ml before injection of SMS 201-995 to 52 pg/ml after injection. Serum norepinephrine levels rose from 50 pg/ml supine (normal range, 150 to 550 pg/ml) and 52 pg/ml erect before injection of SMS 201-995 to 72 pg/ml supine and 110 pg/ml erect after injection. SMS 201-995 may raise blood pressure, in part by increasing the release of circulating norepinephrine.

Screening for gestational diabetes with the one-hour 50-g glucose test.

A one-year experience of screening for gestational diabetes is reported. Patients with any of seven risk factors were screened at the time of prenatal registration. Those without risk factors, and those not found to be diabetic by 24 weeks' gestation, were tested later in pregnancy. Of 4116 patients, 77% had at least one risk factor. The prevalence of diabetes in patients with risk factors was significantly greater than among those with no risk factors (P less than .001). Of 936 patients who had no risk factors, four were found to have diabetes. Multiple logistic regression analysis suggested that family history, obesity, and age over 25 years contributed significantly to the prediction of gestational diabetes. More than 10% of gestational diabetics had screening values between 135-139 mg/dL. Among patients whose early screening values were elevated and whose initial glucose tolerance tests were normal, the odds of being classified ultimately as a gestational diabetic were 7.3 times that of patients whose initial screening tests were normal. Selective screening based on risk factors including maternal age may enhance detection of diabetes early in gestation.

Acute nonvariceal upper gastrointestinal bleeding. Care in three different San Diego practice settings.

We compared the care of all adults admitted directly for acute nonvariceal upper gastrointestinal bleeding in 1981 to three types of hospitals: private (n = 138), health maintenance organization (HMO) (n = 105), and university (n = 72). Some patient characteristics differed, but most indices of blood loss, all final diagnoses, and rates of surgery (less than 9%) and death (less than 5%) were similar. Use of intensive care and blood products differed from published guidelines. Health maintenance organization patients had the shortest stays and the fewest transfusions, limited almost completely to packed red cells. Intensive care unit use and duplicate diagnostic testing were greatest for university patients. Rebleeding rates, determined by including readmissions within 1 week of discharge, were less than 7% and similar at the three institutions. Endoscopic signs of recent hemorrhage from an ulcer were significant signposts to rebleeding. Patients endoscoped early and those without endoscopic signs of recent hemorrhage went home sooner than the others.

Ethnicity and reporting of schizophrenic symptoms.

Eighty-one clinically diagnosed (DSM-III) Hispanic and Anglo schizophrenic subjects were evaluated with a structured diagnostic interview, the National Institute of Mental Health Diagnostic Interview Schedule (NIMH-DIS), and a battery of rating instruments (Brief Psychiatric Rating Scale, Clinical Global Impressions, Global Assessment Scale, and Hopkins Symptom Checklist 90 [SCL-90]). The authors examined: a) consistency in reporting of symptoms across different instruments administered in different formats and b) the importance of ethnic background in consistency of responses to the different instruments. A subgroup of patients (23% of total) "denied" lifetime schizophrenic symptoms in the lay interviewer-administered structured interview ("DIS negative" schizophrenic subjects). The proportion of DIS negative subjects was very similar across the two ethnic groups. However, responses by DIS negative schizophrenic subjects to a self-rating instrument (SCL-90) were significantly different for Hispanic and Anglo subjects. A subgroup of Anglo subjects denied symptoms in the DIS, but volunteered them in the self-rating instrument. Responses of Hispanic subjects were consistent regardless of format.

Dendritic organization of the anterior speech area.

Golgi studies revealed significant differences in dendritic patterns between neurons of the left and right opercular regions of the frontal lobe (Broca's speech area on the dominant side) and between cells of the left and right precentral areas (the orofacial motor zones) just behind. Although total dendritic length of the basilar dendritic array seemed characteristic of an area independent of side, a larger proportion of the length on the left (dominant) side was made up of higher order (4, 5, 6) dendrite branches, and lower order (1, 2, 3) segments predominated on the right. The pattern was partially reversed in non-right-handed patients. These findings can be interpreted as indicating an early preponderance of dendrite growth in the non-speech-gifted hemisphere followed by enhanced dendrite growth in the dominant hemisphere coincident with the beginning of conceptualization and speech function.

Patient-selection criteria for panoramic radiography.

The purpose of this study was to determine whether selection criteria could be developed for the use of panoramic radiographs in the treatment planning of patients seeking dental care. A total of 1,424 patients were included in this 10-month study. Clinicians were asked to indicate what signs or symptoms caused them to order a panoramic radiograph. After the radiograph was taken, the referring clinician was asked to indicate the extent that the panoramic radiograph influenced the patient's care. The panoramic examination was found to be most productive in dentulous patients when no other radiographs were ordered and least productive in dentulous patients who had already had a full-mouth set of radiographs. Considering all patients, it is possible to reduce the number of panoramic examinations by 73% while missing 6% of the findings that influence patient treatment. The most important selection criteria for the panoramic examination are whether the radiograph was ordered for a "general screening examination" (a negative predictor) and whether the radiograph was ordered for any specific examination (a positive predictor).

Chlamydia trachomatis isolation in a symptomatic university student population.

In a study of 638 women attending a University Student Health Service outpatient gynecologic clinic, their symptoms were either lower genital tract infection or a history of suspected exposure to sexually transmitted diseases. Forty-two (6.6%) harbored Chlamydia trachomatis, four (0.8%) Neisseria gonorrhoeae, and one (0.2%) both of these organisms. Chlamydia-positive patients were more likely to be using a contraceptive method, have multiple partners, and have partners with symptoms of urethritis (P = .05). The Chlamydia-positive patients were no more likely to have increased or abnormal vaginal discharge than were controls. Of the women harboring Chlamydia trachomatis, only one of 36 (3%) of those who were available for follow-up at one to eight weeks posttreatment was still infected with the organism.

Nicotine vs. placebo gum in the alleviation of withdrawal during smoking cessation.

In a double-blind, placebo-controlled trial of nicotine gum, withdrawal symptoms were systematically scaled for one week in 50 subjects. Baseline responses on withdrawal items were obtained for comparison to five days of smoking abstinence. Twenty-six subjects receiving nicotine gum and twenty-four subjects receiving placebo gum provided the withdrawal data. A withdrawal scale (SCS) was derived from smokers' complaints in previous abstinence attempts. Pulse rate changes were recorded. Carbon monoxide served to verify abstinence. Pulse rate dropped significantly during abstinence for the placebo vs. nicotine group. All subjects experienced significant increases in withdrawal over time. However, the placebo group reported significantly more severe withdrawal than the nicotine subjects. No sex differences in reported withdrawal were found. It was concluded that the appearance of withdrawal symptoms may be attributed, in part, to the removal of nicotine per se. Conversely, nicotine-specific symptoms may be alleviated with nicotine gum.

The Spanish Diagnostic Interview Schedule. Reliability and comparison with clinical diagnoses.

The National Institute of Mental Health Diagnostic Interview Schedule (DIS) was translated into Spanish. The reliability of the Spanish instrument, its equivalence to the English version, and its agreement with clinical diagnoses were examined in a study of 90 bilingual (English-and Spanish-speaking) and 61 monolingual (Spanish-speaking only) patients from a community mental health center. The study design involved two independent DIS administrations and one independent clinical evaluation of each subject.

An instrument for theory and research development using the behavioral systems model for nursing: the cancer patient. Part II.

The purpose of the Derdiarian Behavioral System Model (DBSM) instrument was to measure and describe, within the Johnson Behavioral System Model (JBSM) perspective, the perceived behavioral changes of the cancer patient. Based on Johnson's (1968, 1980) premise that illness as a noxious stimulus effects imbalance in the behavioral system of the human being, it was extrapolated that changes that occur in a patient's behavioral patterns would be perceived by the patient. Thus, changes would reflect the description of the imbalance in the patient's behavioral system, which needs to be identified and described in a systematic way. The description of change was envisioned in terms of (1) the perceived existence of change; (2) the direction of change--increase or decrease; (3) the quality of change--positive or negative; (4) the importance of change--its significance; and (5) the physical, psychological, or emotional effect(s) of the illness perceived as causally associated with the change.

Nicotine gum in smoking cessation: a placebo-controlled, double-blind trial.

Sixty subjects were run in a study comparing the use of nicotine gum with placebo gum during cessation from smoking. Subjects were given clinic support and chewed the gum ad libitum. A survival analysis showed the two groups differed significantly in successful abstinence over time (p less than .03). Differences between groups appeared early (within weeks) and, at six months, a 28% superiority of nicotine over placebo gum was demonstrated with mean success rates of 48% and 20%, respectively. Between six months and one year, relapse in the nicotine group accounted for the 30% vs. 20% success rates for nicotine and placebo observed at one year. In a pilot study ("dispensary") testing the efficacy of the two gums when intervention was minimal, subjects in both groups resumed smoking within the first two weeks. The enhanced short-term success rates with nicotine gum in the clinic study are attributed to an effective interaction between use of the active preparation and clinic support. Long-term cessation may require extended maintenance procedures and/or an identification of optimal gum use.