Thirty-four spontaneously breathing newborns with respiratory distress synd
rome (RDS) requiring nasal continuous positive airway pressure (CPAP) and a
n arterial-tu-alveolar oxygen tension ratio (a/A PO2) of 0.15-0.22 were ran
domized to treatment with nebulized surfactant (Curosurf(R)) or to serve as
controls. All children were first supported by nasal CPAP according to nor
mal clinical routines. Surfactant was administered using a modified Aiolos(
R) nebulizer. and a total of 480 mg was aerosolized in each case. The contr
ol group received no nebulized material, but had the same CPAP support. Aci
d-base status and a/A PO2 were determined at regular intervals before, duri
ng and after surfactant administration. Both groups included in the study w
ere similar with regard to gestational age, birthweight, steroids given bef
ore birth, sex and Apgar scores as well as a/A PO2 when entering the study.
There were no significant differences between the groups in a/A PO2 1-12 h
after randomization, number of infants needing mechanical ventilation, tim
e on ventilator or CPAP. Two children in the treated group developed bronch
opulmonary dysplasia. No side effects of the surfactant therapy were noted.
No beneficial effects of aerosolized surfactant were demonstrated in our tr
ial, contrary to data from animal experiments. This finding probably reflec
ts differences in administration techniques. Our findings do not justify la
rge clinical trials with the same protocol. Further work is needed to optim
ize delivery of aerosolized surfactant to the neonatal lung in clinical pra
ctice.