Surfactant replacement therapy: a multicentric trial comparing two dosage approaches.

Area of Science:

• Neonatology
• Pulmonology
• Biochemistry

Background:

• Neonatal Respiratory Distress Syndrome (NRDS) is a common condition in premature infants.
• Surfactant replacement therapy is a cornerstone in managing NRDS.
• Optimizing surfactant dosing is crucial for improving treatment efficacy.

Purpose of the Study:

• To compare the efficacy of two different initial doses of porcine surfactant in treating NRDS.
• To evaluate the impact of initial surfactant dose on respiratory support and clinical outcomes.
• To assess mortality rates in relation to surfactant dosage in NRDS patients.

Main Methods:

• A randomized study involving 165 patients with NRDS, divided into two groups receiving either 200 mg/kg (Group A) or 100 mg/kg (Group B) of porcine surfactant initially.
• Patients required mechanical ventilation with high FiO2 and were within 15 hours of postnatal age.
• Additional doses of 100 mg/kg could be administered every 12 hours if FiO2 remained above 0.40.

Main Results:

• Group A (200 mg/kg) demonstrated significantly higher PaO2/FiO2 ratios at 12, 24 hours, and on day 3 compared to Group B (100 mg/kg).
• Group A required lower FiO2 and experienced reduced peak inspiratory pressure at 36 hours.
• Exposure to high oxygen concentrations (FiO2 > 0.40) was significantly shorter in Group A.
• While overall mortality was not significantly different, Group A showed a statistically significant reduction in mortality among infants weighing less than 1,500 grams (p < 0.02).

Conclusions:

• An initial dose of 200 mg/kg of porcine surfactant is more effective than 100 mg/kg in improving oxygenation and reducing respiratory support in NRDS.
• The higher initial dose demonstrates a significant survival benefit in low-birth-weight infants (<1,500g) with NRDS.
• These findings support the use of higher initial surfactant doses for improved outcomes in neonatal respiratory distress syndrome.