Use of surfactant for prophylaxis versus rescue treatment of respiratory distress syndrome: experience from an Italian-Bulgarian trial.

OBJECTIVE: To show if surfactant applied in different social-sanitary realities as prophylaxis of respiratory distress syndrome (RDS) is equally useful and able to reduce mortality and incidence of 3-4 radiological grade RDS. METHODS AND PATIENTS: Two neonatal intensive care units (NICU) in Italy, one NICU in Bulgaria and one NICU in Romania were involved in a randomized controlled clinical trial of prophylaxis vs rescue treatment of RDS. Babies with gestational age 26-30 wks were randomized before birth to prophylaxis in the delivery-room with 200 mg/kg of porcine surfactant (prophylaxis) or to routine assistance (control). Subsequently the babies developing RDS requiring mechanical ventilation and fraction of inspired oxygen (FiO2) > or = 0.4 to maintain PaO2 about 50 mmHg were allowed to be treated rescue with 200 mg/kg of the same surfactant. To reach end-points of reducing mortality by 40% and incidence of radiological grade 3-4 RDS a total number of 174 patients were required. RESULTS: Due to logistic, practical and social-political problems the study was interrupted after enrollment of 93 babies (61 in Italy and 32 in Bulgaria). The Romanian centre did not start the study because it was impossible in the scheduled times to equip it for mechanical ventilation of the newborn infants. Analysis done on an intention to treat basis did not show significant reductions of mortality and 3-4 radiological grade RDS, even if there was a trend towards a reduction in the babies given prophylaxis. A significantly lower number of babies given prophylaxis required a subsequent rescue treatment compared to controls (p < 0.001). There was no difference in other complications such as intraventricular haemorrhage, air-leak syndromes and infections between prophylaxis and control infants. As regards pulmonary gas exchange, the PaO2/FiO2 ratio was significantly improved in the babies given prophylaxis for the first 12 hours of life vs the controls. CONCLUSION: Even if the study was terminated before term, the analysis of the data shows that prophylaxis with surfactant is equally effective in different social-clinical conditions to improve pulmonary gas-exchange, especially in the first critical hours of life of premature babies.

[The surgical treatment of fixed aortic subvalvular stenosis]. / Trattamento chirurgico delle stenosi sottovalvolari aortiche fisse.

Over the past 5 years, 45 patients (11 adults and 33 children) have undergone operations for discrete and fixed subaortic stenosis. The resection of the subvalvular membrane or the fibromuscular collar was the procedure of choice. 28 patients underwent myectomy and/or myotomy. None patients died during operations. No significant symptoms and gradients remained after operation. We conclude that in the surgical management of fixed discrete subaortic stenosis myectomy and myotomy in addition to membranectomy produces better relief of the left ventricular outflow obstruction than do membranectomy alone.

Management of preterm infants receiving surfactant supplementation.

The use of exogenous surfactant in the clinical management of severe neonatal respiratory distress syndrome (RDS) has raised some potential new problems related to the rapid variations in oxygenation and pulmonary compliance occurring after this treatment. We advise a strict monitoring of arterial oxygen tension (Pao2), preferably by a non-invasive technique and rapid resetting of the ventilator as indicated by changes in pulmonary compliance and lung aeration after surfactant administration. The goal should be to minimize the risks of air leakage, left-to-right shunt, and overloading of the pulmonary circulation. Rapid diagnosis and treatment of patent ductus arteriosus and appropriate fluid intake are also essential for a favourable outcome in newborn infants with severe RDS treated with surfactant.

Antenatal prevention of respiratory distress syndrome; a multicentre survey.

Obstetric and neonatal data were collected on 934 preterm deliveries in 11 Italian centres in 1980, 1985 and 1986. Therapeutic regimens for prevention of respiratory distress syndrome (RDS) were applied in 42% of the cases in 1980, 32% in 1985 and 42% in 1986. Prevention was made in most cases with corticosteroids, although their use fell progressively from 94% in 1980 to 74% in 1986. A combination of two substances was used in a percentage of cases varying from 5 to 10% in all three years. In 903 non-malformed infants, the overall incidence of RDS was not significantly different in cases in which pharmacological prevention was attempted compared with cases without prevention. The only factors significantly affecting the incidence of RDS were gestational age, birth weight and Apgar score.

[Controlled study on the prevention of respiratory distress syndrome with betamethasone in pregnancy and ACTH and cortisol levels in the premature newborn infant]. / Studio controllato sulla prevenzione della RDS con betametasone in gravidanza e livelli di ACTH e cortisolo nel neonato pretermine.

The influence of maternal corticosteroid administration was studied on the ACTH and cortisol concentrations in neonatal blood of 24 premature infants whose mothers received betamethasone for prevention of RDS, compared with 11 untreated subjects. Cord blood was taken at birth and from venous sample in 5th day. All samples were analyzed for ACTH and Cortisol by radioimmunoassay. No statistically significant differences between these groups were noted. Additional analysis of ACTH and Cortisol levels in 9 RDS premature infants versus 26 control ones failed to demonstrate any deficiency of corticosteroids in newborn infants with RDS. The findings provide a justification for the prepartum treatment of respiratory distress syndrome with glucocorticoids because this dose of betamethasone does not expose the newborn to potentially harmful effects.

[Prognosis for newborns of very low birthweight (author's transl)]. / Destino dei neonati di peso molto basso alla nascita.

During the 5 years, 1975-1979, 144 infants weighing less than or equal to 1500 g (ranging from 400 to 1500 g) were admitted to the Neonatal Intensive Care Unit of Mantua. 57 (40%) survived the neonatal period. The principal cause of death was hypoxia and hyaline membrane disease. After leaving the hospital, all the children were seen regularly to 1 year of age and 47 (82%) to 5 years of age. The infants received a neurological and physical evaluation at variable intervals; severe neurological handicaps were found in 2 (3,5%) infants, mild handicaps were observed in 6 (10,5%) infants. Pathological EEG was found in 1 (1,7%) case. The DQ was evaluated by the Gesell test; the DQ was below 80 in 1 child, between 80 and 89 in 2 infants and above 89 in the remaining cases. Three children had strabismus, none had retrolental fibroplasia. Follow-up audiometry was normal in all the subjects. The Authors conclude that intensive care increases the survival and reduces the incidence of serious handicaps in the newborns of very low birthweight.