Biomedical subjects

R F Soll

Publications and source records attributed to R F Soll.

43 records · Page 3Linked to original sources

PubMed1991

Surfactant proteins and anti-surfactant antibodies in sera from infants with respiratory distress syndrome with and without surfactant treatment.

The presence of surfactant protein antigenemia and of surfactant protein antibodies was determined in serum from surfactant-treated and control infants with respiratory distress syndrome who were enrolled in a prospective randomized clinical trial. The surfactant used for treatment (surfactant TA) contained surfactant proteins (SPs) B and C and no SP-A. Enzyme-linked immunosorbent assays (ELISAs) that identify surfactant-associated proteins and ELISAs that identify IgG or IgM directed against surfactant proteins were used to investigate sera from these infants obtained prior to treatment, at 1 week of age, and at 2 months of age. There were no significant differences between average values in the surfactant-treated and control groups at each time period. However, in the control group, averaged results from ELISAs that identify SP-A and that identify IgM antibodies to SP-A or to SP-B, C showed significant differences between pretreatment sera and sera obtained at 1 week of age. No significant differences were noted in averaged results for IgG. Positive ELISA values were more frequently found in the control group than in the surfactant-treated group with regard to SP-A, and IgM against SP-A and SP-B, C in sera from neonates at 1 week of age. No positive ELISA values were found in sera from infants at 2 months of age. It is concluded that some patients with severe respiratory distress syndrome presumably leak surfactant proteins into the circulation and that this induces transient low titers of IgM antibody. This occurrence is decreased with surfactant treatment. Surfactant treatment may reduce leak of surfactant proteins into the vascular space by reducing lung damage.

Animals↗

PubMed1990

A European multicenter randomized controlled trial of single dose surfactant therapy for idiopathic respiratory distress syndrome.

We performed a multicenter prospective randomized controlled trial to determine the efficacy and safety of the surfactant preparation, Survanta (Abbott Laboratories, Chicago, USA), for 750-1750 g infants with idiopathic respiratory distress syndrome, (IRDS) receiving assisted ventilation with 40% or more oxygen. One hundred and six eligible infants from the eight participating centers were randomly assigned between March 1986 and June 1987 to receive either surfactant (100 mg phospholipid/kg, 4 ml/kg) or air (4 ml/kg) administered into the trachea within 8 h of birth (median time of treatment 6.2 h, range 3.2-9.1 h). The study was stopped before enrollment was completed at the request of the United States Food and Drug Administration when significant differences were observed in incidence of periventricular-intraventricular hemorrhage (PIH), between the surfactant treated and control infants. Surfactant treated infants had larger average increases in the arterial-alveolar oxygen ratio, (a/A ratio) (P less than 0.0001), and larger average decreases in FiO2 (P less than 0.0001) and mean airway pressure, (MAP) (P less than 0.017) than controls over the 48 h following treatment. The magnitude of the differences between the surfactant and control groups were 0.19 (SE = 0.03) for a/A ratio, -0.28 (SE = 0.04) for FiO2 and -1.7 cm H2O (SE = 0.70) for MAP. The clinical status on days 7 and 28 after treatment was classified using four predefined ordered categories: (1) no respiratory support; (2) supplemental O2 with or without continuous positive airway pressure (CPAP); (3) intermittent mandatory ventilation; and (4) death. There were no statistically significant differences in the status categories on days 7 or 28 between surfactant and control infants.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Inhalation↗

PubMed1990

Health and developmental outcomes of a surfactant controlled trial: follow-up at 2 years.

Several randomized clinical trials have shown that surfactant therapy improves the pulmonary status of infants with respiratory distress syndrome and has the potential to reduce morbidity and mortality in these infants. Relatively little is known, however, about the long-term consequences of surfactant treatment. In this report, the results of health and developmental assessment are described at 1 and 2 years of age of 32 survivors of an initial group of 41 infants enrolled in a randomized clinical trial of bovine surfactant therapy. The frequencies of abnormal findings were comparable in the two groups although there was a trend toward a greater frequency of allergic manifestations in the control group (6 of 16 (38%) vs 1 of 15 (7%), P = .08). Similarly, no differences were seen in the mental and motor scores of the Bayley Scales of Infant Development at either 1 or 2 years of age. This study and other recently published reports of follow-up studies of infants treated with surfactant provide encouraging evidence that major long-term side effects do not result from surfactant therapy.

Animals↗

PubMed1990

Multicenter trial of single-dose modified bovine surfactant extract (Survanta) for prevention of respiratory distress syndrome. Ross Collaborative Surfactant Prevention Study Group.

A multicenter, prospective randomized controlled trial was performed comparing the efficacy of a single intratracheal dose of modified bovine surfactant extract (Survanta, 100 mg/kg, Abbott Laboratory, North Chicago, IL) with air placebo in preventing respiratory distress syndrome. Infants were enrolled if they were estimated to be between 24 and 30 weeks' gestation, weighed between 750 and 1250 g, and were intubated and stabilized within 15 minutes after birth. A total of 160 infants were treated (79 with surfactant, 81 with air placebo) between 4 and 37 minutes after birth (median time 12 minutes). Of these, 5 infants were excluded from the final analysis. The 72-hour average values for the arterial-alveolar oxygen ratio, fraction of inspired oxygen, and mean airway pressure were calculated from the area under the curve of scheduled values measured throughout 72 hours. Clinical status was classified using five ordered categories (no supplemental oxygen or assisted ventilation, supplemental oxygen only, continuous positive airway pressure or assisted ventilation with intermittent mandatory ventilation less than or equal to 6 breaths/min, assisted ventilation with intermittent mandatory ventilation greater than 6 breaths/min, death). Chest radiographs at 24 hours were graded for severity of respiratory distress syndrome. Infants receiving Survanta had less severe radiographic changes at 24 hours of age and decreased average fraction of inspired oxygen (31% vs 42%, P = .002) compared with control infants. No differences were noted in the average arterial-alveolar oxygen ratio, mean airway pressure, or clinical status on days 7 and 28. A beneficial effect was noted in the incidence of pneumothorax (P = .057) and an increase was noted in the incidence of necrotizing enterocolitis (P = .052). No differences in incidence of patent ductus arteriosus, intraventricular hemorrhage, sepsis, or bronchopulmonary dysplasia were seen. According to results of a secondary analysis, there was improvement in the fraction of inspired oxygen and a greater number of survivors without bronchopulmonary dysplasia in the subgroup of infants weighing less than 1000 g who were treated with surfactant. It was concluded that a single dose of Survanta given shortly after birth resulted in decreased severity of chest radiographic findings 24 hours after treatment and improved oxygenation during 72 hours after treatment, but did not improve other acute measures of disease severity or clinical status later in the neonatal period. The group at highest risk for respiratory distress syndrome (infants with birth weights between 750 and 999 g) may benefit the most from preventive therapy.

Animals↗

PubMed1989

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

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 less than 0.0001), a 0.20 greater average decrease in the fractional inspiratory oxygen concentration (P less than 0.0001), and a 0.26-kPa greater average decrease in the mean airway pressure (P less than 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, necrotizing 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 surfactant 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 does not reduce neonatal mortality. Further study of different surfactant regimens and patient-selection criteria will be required to determine whether this initial improvement can be translated into reductions in mortality or serious morbidity.

Bronchopulmonary Dysplasia↗

PubMed1987

Episodic abnormalities in transcutaneous oxygen (TcPO2) recorded during neonatal intensive care.

An automated TcPO2 data system was tested and used to: 1) quantitate the frequency and duration of hypoxemic and hyperoxemic events experienced during the first three days after birth by 25 very low birth weight infants, and 2) determine whether hypoxemic events were associated with the occurrence of periventricular-intraventricular hemorrhage. During the first three days after birth, infants experienced a median of 41 episodes with a TcPO2 less than 40 torr having a cumulative duration of 37 minutes, and a median of 28 episodes with a TcPO2 greater than 100 torr having a cumulative duration of 14 minutes. Most episodes were less than 30 seconds in duration, but in some infants the duration was longer. There was no association between the occurrence of periventricular-intraventricular hemorrhage and either the frequency or cumulative duration of episodes with a TcPO2 less than 40 torr. A major problem with automated TcPO2 data systems is the inability of currently available systems to recognize inaccurate TcPO2 data. Twenty-four per cent of the summary TcPO2 monitoring data collected in this study was contaminated with unreliable TcPO2 values. Before automated TcPO2 data systems can be recommended for widespread research use or for medicolegal documentation, the problem of data contamination must be resolved.

Blood Gas Monitoring, Transcutaneous↗

PubMed1987

Randomized controlled trial of exogenous surfactant for the treatment of hyaline membrane disease.

We conducted a prospective, randomized, unblinded, controlled trial of exogenous bovine surfactant (surfactant TA) in premature infants requiring ventilator support for the treatment of severe hyaline membrane disease. Forty-one low birth weight infants with severe hyaline membrane disease were randomly assigned to saline or surfactant therapy and treated within eight hours of birth. Significant improvements in oxygenation (increased arterial/alveolar PO2) and respiratory support (decreased mean airway pressure) were seen in the group receiving surfactant within four hours after treatment. These improvements were maintained in the surfactant-treated infants, who also had fewer pneumothoraces and fewer number of days in environments of fractional inspiratory oxygen greater than 0.4 mm Hg. No problems were associated with administration of surfactant, and no acute side effects were detected. We conclude that exogenous surfactant, administered early in the course of severe hyaline membrane disease, is an effective therapy that can diminish the amount of respiratory support required during the first 48 hours of life.

Animals↗