Abstract
Patients and methods: A controlled multicenter clinical trial was carried out to determine the effect of bovine surfactant (SF-RI 1) given to very premature infants (≤ 30 weeks GA) during the first hour after birth. The SF-FI 1 group (n=34, GA (± SD) 28.0±1.6 weeks, birth weight 1048±299 g) received 50 mg/kg bovine surfactant during the first hour after birth and the control group (n=35, GA 27.6±2 weeks, birth weight 969±269 g) received air via the ET tube. Re-treatment with identical doses (maximum 3 additional doses) was permitted. The primary outcome was categorized as survival without BPD at 28 days (criteria: ventilator dependence or FIO2 >0.3 during spontaneous respiration).
Results: Survival rate without BPD was significantly higher (p=0.002) in SF-RI 1 infants (26/34) than in control infants (14/35). Surfactant treatment acutely improved lung function (FiO2↓, pa/AO2↑, MAP↓) during the first hours after birth. No differences were observed between both groups comparing the incidence of PDA, IVH, NEC and other nosocomial infections.
Conclusion: Early treatment with SF-RI 1 acutely improves pulmonary function and survival without BPD in very premature infants at risk for RDS.
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Gortner, L., Bernsau, U., Hellwege, H. et al. CONTROLLED MULTICENTER CLINICAL TRIAL OF BOVINE SURFACTANT (SF-RI 1) FOR PREVENTION RESPIRATORY DISTRESS SYNDROME IN VERY PREMATURE INFANTS. Pediatr Res 26, 512 (1989). https://doi.org/10.1203/00006450-198911000-00076
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DOI: https://doi.org/10.1203/00006450-198911000-00076
