THERAPY OF NEONATAL RESPIRATORY-DISTRESS SYNDROME (NRDS) BY ALVEOFACT(R) - RESULTS OF A PROSPECTIVE OBSERVATIONAL STUDY

Aim After registration of the bovine Surfactant Alveofact(R) (Fa. Thom ae) for treatment of neonatal respiratory distress syndrom (RDS) an ob servational study was performed in 47 german neonatal departments to r egister indication, effectivity, mode of administration and unexpected side effects. Methods 680 ventilated preterm infants (gestational wee ks 29,5+/-2,9; birth weight 1359+/-507 g) were enrolled in an uncontro lled clinical study with study-protocol, prospectively defined outcome s and covariates, manual of operation, central control system, biometr ical control. Results Surfactant was applicated at a postnatal age of 2 hours 56 minutes (median). Only 2.9% of newborn infants got the firs t surfactant dosis <6 min postnatally, 19.4% between 6 ... 60 min and 77.7% >60 min postnatally. Following 1338 instillations in 76% an impr oved lung function, in 21% no change and in 3% a worsening was observe d. During the study the total dose of surfactant increased. Safety con siderations determined by the rate of pulmonary and extrapulmonary com plications were similar to data of the literature: pneumothorax 12%, p ulmonary interstitial emphysema 11.6%, secondary pneumonia 20.4%, bron cho-pulmonary dysplasia 27%, pulmonary hemorrhage 2.1%, peri/intravent ricular hemorrhage (degree III/IV) 27.9%, ductus arteriosus sus persis tens 24.4%, sepsis/meningitis 12.4%. During the study the mortality re duces from 31% (first period) to 18% (third period) the mean was 20%. In 44 infants (6.5%) a disturbed ventilation (airway obstruction, over dystension of pulmonary areas, atelectasis) after surfactant administr ation was observed. Conclusion In RDS the surfactant Alveofact is pref erably used therapeutically (rescue mode), it is effective but not fre e of risk. Its administration needs for a clear indication. New unknow n side effects of Alveofact were not observed.