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Treatment with surfactant may increase the risk of intracranial hemorrhage in newborn infants with a low birth weight. Surfactant is a substance occurring naturally in the lungs that is used to treat respiratory distress syndrome in premature infants. Intracranial hemorrhage is bleeding within the cranium, or the upper part of the head. Researchers reviewed studies that examined the association between surfactant replacement therapy and intracranial hemorrhage in newborn infants. Treatment with the surfactant beractant elevated the risk of grade I or grade II intracranial hemorrhage in infants with a birth weight of 600 to 750 grams. Surfactant replacement therapy with beractant did not increase the risk of a grade III or IV intracranial hemorrhage among this group of infants. Grades I and II are less serious than grades III and IV, which may lead to neurological handicaps. Infants treated with surfactant should be monitored closely for potential complications.

Survanta appears to be safe in the prevention and treatment of respiratory distress syndrome (RDS) among premature infants. Survanta is a synthetic lung surfactant that reduces surface tension and improves the elasticity of the lungs. Of 8,168 premature infants, 2,670 were given Survanta for the prevention of RDS, and 5,498 were given Survanta for the treatment of RDS. Overall, 56.8% of the infants required more than one dose, and 23% received the maximum four doses. There were problems with the administration of Survanta at least once in 30.4% of the infants. Adverse events occurred in 0.5% of the infants, but only one event was attributed to Survanta treatment. The overall survival rate was 84.4%., From September 1989 through July 1991, before commercial availability, Survanta (beractant intratracheal suspension), a modified bovine-derived surfactant used for prevention and treatment of neonatal respiratory distress syndrome, was made available to 231 neonatal intensive care units in the United States and Canada under a Treatment Investigational New Drug protocol. Results of this open clinical experience are reported. Investigators could give one dose of Survanta soon after birth to neonates weighing 600 to 1250g (prevention strategy). Neonates weighing 600 to 1750g who were not treated at birth could begin Survanta therapy if respiratory distress syndrome developed within 8 hours of birth (rescue strategy). All neonates could receive up to three more doses over the first 48 hours of life at minimum intervals of 6 hours if they met retreatment criteria. Qualifications for enrollment closely matched those used in previous randomized controlled clinical trials. This report includes results from 8168 neonates who completed the study. Treatment Investigational New Drug rates for intracranial hemorrhage, patent ductus arteriosus, pulmonary hemorrhage, pulmonary air leaks, bronchopulmonary dysplasia, death or bronchopulmonary dysplasia, pulmonary interstitial emphysema, pretreatment sepsis, and posttreatment sepsis were less than for treated neonates in the controlled trials and survival was equivalent across studies. Problems with treatment administration were reported with 30.4% of doses, while adverse events were reported in 0.5% of neonates. The results of the Treatment Investigational New Drug protocol revealed no new safety concerns associated with the widespread use of Survanta and confirmed the safety profile established in earlier controlled trials. Pediatrics 1993; 91:546-551; Treatment Investigational New Drug, pulmonary surfactant, bovine surfactant, respiratory distress syndrome, hyaline membrane disease, prematurity, neonatal mortality.

Infants born prematurely have an increased risk of respiratory distress syndrome, a lung disorder, because the lungs are still immature and do not produce adequate quantities of a substance called surfactant. This condition can be fatal. Studies have shown that a natural surfactant derived from other species given once at birth to these infants can reduce the severity of respiratory distress syndrome, but survival rates have not been shown to increase. This study examined whether giving multiple doses of a natural surfactant derived from cows (bovine surfactant) to these infants could increase their chances of surviving respiratory distress syndrome. Infants born at 23 to 29 weeks gestation weighing between 600 and 1,250 grams (1.3 to 2.8 pounds) were included in the study. A total of 430 infants participated, with 210 assigned to the treatment group and 220 to the control group. The treatment group received the surfactant at birth and again when needed (delivered into the trachea, or windpipe), while the control group received a dose of air, which functioned as a placebo. Results showed that in the first 28 days after birth, 1.9 percent of the treated and 15.6 percent of the untreated infants died from respiratory problems, a significant difference. Respiratory distress syndrome developed in 28 percent of the treated and in 56.9 percent of the control infants. The treated infants also had lower rates of developing pulmonary interstitial emphysema, at 23.3 percent versus 36.9 percent for the control group. These results indicate that multiple treatments with a natural surfactant at birth and again when needed can reduce the rates of illness and death from respiratory problems in infants born prematurely. (Consumer Summary produced by Reliance Medical Information, Inc.)

Infants born prematurely often suffer from lung problems such as respiratory distress syndrome that increase their risk of illness and death above that of full-term infants. Premature infants lack a substance called surfactant in the lungs which is essential for respiratory function. In the past decade, it was found that a surfactant derived from cows (bovine surfactant) could be given to these infants, and that this decreased the need for oxygen and ventilation (use of a breathing machine). Further studies found that a single dose given at birth reduced the severity of the symptoms of respiratory distress syndrome, but did not necessarily increase survival rates. This study examined if giving more than a single dose of the surfactant when disease persisted would increase survival rates in these infants. The study involved 798 infants born prematurely weighing between 600 and 1,750 grams (1.3 and 3.9 pounds) that developed respiratory distress syndrome within six hours after birth. The infants were randomly assigned to one of two groups; one was the control group (396 infants) and the other received an initial dose of the surfactant with repeated doses if needed (402 infants). Results showed that in the first 28 days after birth, 36 treated infants (9 percent) and 80 untreated infants (20 percent) died from respiratory distress syndrome. Deaths from all causes during this period were 74 (18 percent) in the treated group and 108 (27 percent) in the untreated group. Mean airway pressure and oxygenation values, measures of respiratory function, during the first 72 hours of life were significantly better in the treated than in the untreated infants. The treated infants also developed significantly fewer cases of pulmonary interstitial emphysema and of pulmonary air leaks than the untreated infants. These results indicate that multiple doses of bovine surfactant given to premature infants with respiratory distress syndrome can reduce the incidence of illness and death. (Consumer Summary produced by Reliance Medical Information, Inc.)