Randomized controlled trial of very early continuous distending pressure in the management of preterm infants. Combined hormonal therapy for the prevention of respiratory distress syndrome and its consequences. Risk of respiratory distress syndrome after prenatal dexamethasone treatment. Effect of antenatal dexamethasone administration on the prevention of respiratory distress syndrome. Preterm premature ruptured membranes: a randomized trial of steroids after treatment with antibiotics. Early versus delayed surfactant administration in extremely premature neonates with respiratory distress syndrome ventilated by high-frequency oscillatory ventilation. Comparative efficacy of exosurf and survanta surfactants on early clinical course of respiratory distress syndrome and complications of prematurity. Antenatal glucocorticoid therapy for the prevention of respiratory distress syndrome in the premature infant. [Administration of exogenous surfactant in premature very low birth weight infants with RDS].
Application of continuous distending pressure at birth (very early CDP) should stabilize the immature airways and reduce the severity of respiratory distress syndrome (RDS) in preterm infants. Eighty-two preterm infants of less than 32 weeks gestation were randomly assigned at birth to early treatment group (TG), in which CDP of 6 cm water pressure was applied at birth by the nasopharyngeal route (NP-CDP), or to control group (CG), in which CDP was applied when indicated for established criteria (pO2 less than 50 mmHg in FiO2 greater than 0.5). Characteristics of the infants in the two groups were comparable. No statistically significant difference between the two groups was found in the incidence of RDS. The course of RDS, and oxygen and ventilatory requirements also did not appear to be changed. In blood gas parameters of most of the time frames, no significant difference was found between the two groups when the results were analyzed according to the assigned group. When the results were analyzed separately for the infants who developed RDS, infants in TG appear to have fared worse from the therapy in terms of oxygenation, as indicated by significantly higher FiO2 (P less than 0.01) and lower a/A (P less than 0.01) values on the third day of the course of RDS, as compared to infants in CG. The incidence of complications was comparable in the two groups. Four infants from TG (9.3%) and one from CG (2.6%) died (P = NS). We conclude that VECDP by nasopharyngeal route does not reduce the incidence of RDS and does not appear to improve the outcome and may worsen the severity of RDS when compared to application of CDP for established criteria. In performing this meta-analysis, we have attempted to use comparable data, but there are limitations to the information that is available at present. Some studies reported results for all patients entered, whereas others reported only optimally treated patients (Table 2). Many of the trials have not yet been published in final form and subjected to peer review. In addition, all the studies reported here were conducted before the widespread use of surfactant therapy. It is unclear whether the benefit of antenatal TRH and steroid therapy on end points such as death or BPD would persist if surfactant was also used. (Surfactant has, however, little impact on the percentage of survivors with BPD, perhaps because sicker infants survive with this treatment and go on to develop BPD.) Studies comparing antenatal TRH plus steroid plus postnatal surfactant to antenatal steroid plus postnatal surfactant are clearly required, and are in progress in a number of centers around the world. Because of these limitations, the routine use of antenatal TRH plus steroid cannot be currently recommended. However, the apparent benefits of this therapy in terms of RDS, death, and CLD that have been reported here do suggest that it might be used in selected situations. An example is threatened delivery of a very premature infant with an immature amniotic fluid pulmonary maturation profile. These infants are at risk for RDS and CLD, even if antenatal steroid and postnatal surfactant therapy is used.(ABSTRACT TRUNCATED AT 250 WORDS) A prospective double-blind randomized clinical trial was carried out to determine whether glucocorticoid treatment reduces the risk of respiratory distress syndrome (RDS) in prematurely born infants. There were 127 infants born to 122 mothers who received either steroid (dexamethasone phosphate) or placebo. No differences between groups occurred in risk factors for RDS (eg, prepartum asphyxia, male sex, cesarean section). When those who received a full course of dexamethasone therapy were compared with those who received placebo, a significant reduction was found in risk, severity, and deaths due to RDS. An increased incidence of infection in mothers treated with steroid was evident, particularly after premature rupture of membranes. We conclude that steroids are effective in reducing risk of RDS, but safer and more efficacious approaches for the prevention of RDS should be sought. A double-blind, collaborative, randomized trial was initiated in 1976 to evaluate dexamethasone administered to mothers as a method of preventing neonatal respiratory distress syndrome (RDS). Five centers enrolled 696 women at risk for premature delivery. Up to 20 mg of dexamethasone phosphate (5 mg every 12 hours) or a placebo was administered intramuscularly. The overall incidence of RDS was different between control subjects (18.0%) and steroid-treating mothers (12.6%) (P less than 0.05). The effect was, however, mainly attributable to discernible differences among singleton female infants (P less than 0.001), whereas no treatment effect was observed in male infants (P = 0.96). Non-Caucasians were improved whereas Caucasians showed little benefit. Fetal and neonatal mortality and maternal postpartum infection rates were not different. Neurologic examination at 40 weeks' gestation demonstrated no significant difference in the rate of abnormal outcomes in the neonatal steroid group (P = 0.2). To assess the effectiveness of corticosteroids in patients with preterm premature rupture of membranes (PROM) after treatment with a broad-spectrum antibiotic, ampicillin-sulbactam.
                A randomized clinical trial of corticosteroids in patients with preterm PROM was undertaken after treating these patients for a minimum of 12 hours with ampicillin-sulbactam. No digital vaginal examinations were performed on these patients. Antibiotics were continued for 7 days and the steroids were repeated weekly. No tocolytics were used. The primary outcome measure was the incidence of respiratory distress syndrome (RDS). Secondary outcome measures included latency period and neonatal and maternal infectious morbidity.
                Seventy-seven patients were enrolled and data about their pregnancies were analyzed. No statistically significant difference in latency period was noted (14.7 days in the steroid group, 15.8 days in the no-steroid group). Both neonatal and maternal infectious morbidity were similar. A significant reduction in the incidence of RDS (18.4 versus 43.6%, P = .03) were observed in the steroid group.
                These data suggest that treating preterm PROM patients with a broad-spectrum antibiotic before corticosteroids decreases RDS without apparent adverse sequelae. To determine whether early surfactant administration is superior to selective delayed treatment in terms of improving survival and/or reducing chronic lung disease in extremely premature neonates with respiratory distress syndrome (RDS) treated by high-frequency oscillatory ventilation (HFOV).
                Prospective randomized clinical trial.
                Tertiary neonatal intensive care unit (NICU) in the Perinatology Center of Prague.
                Forty-three extremely premature infants who needed artificial ventilation within 3 h after delivery.
                Patients were randomly assigned to either early ( n=21) or delayed (n=22) administration of surfactant. All were ventilated by HFOV as the primary mode of ventilation using the high volume strategy aimed at optimizing lung volume. Curosurf at a dose of 100 mg/kg was given as a single bolus via the endotracheal tube within 1 min immediately after intubation in the early group (EARL), or during HFOV only when defined criteria were reached in the delayed (DEL) group.
                No differences were noted in demographic data between the two groups. Fewer infants randomized to the EARL group required oxygen use or died at 36 weeks (combined outcome 29% vs 64%, p=0.021), and there was a lower incidence of any intraventricular hemorrhage in this group (43 vs 82%, p=0.008).
                When compared to delayed dosing, early administration of surfactant followed by HFOV facilitates and accelerates respiratory stabilization during the acute phase of severe RDS, may reduce the incidence of chronic lung disease or death and may positively influence the incidence of severe intracranial pathology in extremely premature infants with primary surfactant insufficiency. To determine the comparative efficacy of Exosurf Neonatal and Survanta surfactants on the early course of respiratory distress syndrome (RDS), arterial blood gases, ventilatory support, outcome morbidity rate, and complications of prematurity and RDS.
                Medical records from 203 premature newborn infants undergoing mechanical ventilation for respiratory distress syndrome, and who received up to four rescue doses of either Exosurf or Survanta, were retrospectively reviewed.
                All groups were comparable for birth weight and gestational age. Although the two randomized groups were similar in severity of RDS based on fraction of inspired oxygen (FIO2) and ventilatory support, a significantly greater improvement in respiratory function as evidenced by FIO2, mean airway pressure, alveolar-arterial partial pressure of oxygen difference, and oxygen index, was observed in the Survanta group from 12 hours (p < 0.05) through 48 hours (p < 0.01). Comparison of outcome morbidity rate by gestational age showed a higher occurrence of retinopathy of prematurity (p < 0.02) among the older infants (28 to 32 weeks) who were treated with Exosurf.
                Survanta exerted a significantly faster response in the early clinical course of RDS compared with Exosurf. However, no difference in the impact on eventual respiratory outcome was observed. We therefore conclude that both surfactants are effective for the treatment of RDS. A double-blind study was designed to investigate the effects of antenatal glucocorticoids on the incidence of respiratory distress syndrome (RDS) in 128 premature human infants. There was a significant reduction (P less than 0.05) in the incidence of RDS in the betamethasone-treated infants to 8.7% compared to an incidence of 22.6% in the saline-treated controls and 25.0% in infants whose mothers received methylprednisolone. The effectiveness of betamethasone in reducing RDS was limited to premature infants delivered to mothers with intact fetal membranes and with an initial L/S ratio less than 2.0. The time between administration of the glucocorticoid and delivery did not significantly affect the incidence of RDS in this study. The failure of methylprednisolone to reduce the development of RDS in premature infants suggests its potential use in maternal therapy during pregnancy with minimal effects on fetal maturation. A retrospective study is carried out with the aim of establishing the effect from surfactant therapy on pulmonary function, survival and complication from intensive therapy on VLBWI with RDS. 67 premature infants below 1500 grams are included in the study divided in 3 groups: I gr.--27 babies treated with Corosurf; II gr.--16 babies treated with Exosurf; III gr.--24 control babies without surfactant. The results show that in spite of relatively lower gestational age and higher incidence of inborn infection in group I, Curosurf treated babies spend shortest time on mechanical ventilation and oxygen therapy showing lower incidence of BPD, IVH and mortality rate.
Early application of CDP has a clinical benefit in the treatment of RDS in that it reduces subsequent use of IPPV and thus may be useful in preventing the adverse effects of this treatment. However, many of the trials were done in the 1970s and 1980s and re-evaluation of the strategy of early CDP in the era of antenatal steroid use and early surfactant administration is indicated focusing on administration methods.