A multicenter randomized, placebo-controlled trial of surfactant therapy for respiratory distress syndrome

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Int. J. Gytuxol. O&et., 1989,30: 189-197 International Federation of Gynecology and Obstetrics

Citations from the Literature This is a selection of abstracts of papers taken from the literature in the field of obstetrics and gynecology which the Journal’s Editors feel may be of general interest to our readers*

PERINATOLOGY A multicenter randomized,

placebo-controlkd trial of surfactant therapy for respiratory dktress syndrome Horbar JD; Soll RF; Sutherland JM; Kotagal U; Philip AGS; Kessler DL; Little GA; Edwards WH; Vidyasagar D; Raju TNK; Jobe AH; Ikegami M; Mullett MD; Myerberg DZ; McAuliffe TL; Lucey JF Department of Pediatrics, University of Vermont College of Medkine, Burlington, VTO5405; USA New England Journal of Medicine/328/15 (959-%5)/1989/ We carried out a multicenter randomized, placebo-controlled trial to evaluate the efficacy and safety of surfactant in the treatment of respiratory distress syndrome. The study population was made up of newborn infants weighing 750 to 1750 g who were receiving assisted ventilation with 40 percent or more oxygen. The eligible infants received a single dose of either surfactant (100 mg of phospholipid per kilogram of body weight (4 ml per kilogram)) or an air placebo (4 ml per kilogram), administered into the trachea within eight hours of birth by an investigator not involved in the clinical care of the infant. When compared with the infants who received the placebo (n = 81). the infants who were treated with surfactant (n = 78) had a 0.12 greater average increase in the ratio of arterial to alveolar oxygen tension (P < O.OOOl),a 0.20 greater average decrease in the fractional inspiratory oxygen concentration (P < 0.0001). and a 0.26kPa greater average decrease in the mean airway pressure (P < 0.0001) during the 72 hours after treatment. Pneumothorax was less frequent among the infants treated with surfactant than in the control group (13 percent vs. 37 percent; P = 0.0005). There were no statistically significant differences between the groups in the proportion of infants in each of five ordered clinical-status categories on day 7 (P = 0.08) or day 28 (P = 0.75) after treatment. There were also no significant differences between the groups in the frequency of bronchopulmonary dysplasia, patent ductus arteriosus, necrotixing enterocolitis, or periventricular-intraventricular hemorrhage. In each group, 17 percent of the infants died by day 28. We conclude that treatment with the single-dose surfactam regimen used in this study reduces the severity of respiratory distress during the 72 hours after treatment and decreases the frequency of pneumothorax, but that it does not significantly improve clinical status later in the neonatal period and *Generated from the Excerpta Medica database, EMBASE.

does not reduce neonatal mortality. Further study of different surfactant regimens and patient-selection criteria wiIl be required to determine whether this initial improvement can be translated into reductions in mortality or serious morbidity. Endocrine maturation aod long function in prematan oeonates of women with diabetes Parker CR Jr; Hauth JC; Hankins GDV; Leveno K; Rosenfeld CR; Porter JC; MacDonald PC Department of Obstetrics and Gynecology, University of Alabama, Birmbagham. AL 35294; USA American Journal of Obstetrics and Gynecology/l6O/3 (657662)/1989/ Because respiratory distress syndrome may result, in part, from a hormonal deficiency in the developing fetus, we investigated the endocrine milieu of 28 infants of women with diabetes who were delivered prematurely (34 to 37 weeks of gestation). The umbilical serum concentrations of estrone, estradiol. estriol, cortisol, and prolactin in infants of women with diabetes who developed respiratory distress syndrome (n = 6) were lower than those in infants of women with diabetes who had normal lung function. Serum hormone levels in agematched newborns of normal women were higher than those in the infants of women with diabetes with respiratory distress syndrome but were not different than those in the infants of women with diabetes with normal lung function. Plasma glucose levels were highest in women whose neonates developed respiratory distress syndrome. An inverse correlation existed between maternal glucose levels and lecithin-sphingomyelin ratios in amniotic fluid. Thus diabetes occasionally results in significantly delayed maturation of the fetal endocrine milieu. In these instances, delayed fetal lung maturation is a frquent occurrence. Moreover, both phenomena may be related to the extent of diabetic control during pregnancy. Bolus tocdysis: Treatment of pnterm Imbor with pdsatile administration of a beta-adrenergk agonist Spatling L; Fallenstein F; Schneider H; Dancis J Department of Obstetrics and Gynecology, University of Bochum. Bochum; German Federal Republic American Journal of Obstetrics and Gynecology/l60/3 (713717)/1989/ The treatment of premature labor with beta-adrenergic substances is complicated by side effects. Although most human control mechanisms are pulsatile, therapy is usually administered continuously. We designed a microprocessor-controlled Int J Gynecoi Ohstet 30