Surfactant composition
The recruiting centre did randomisation with a unique subject identifier specific to that centre. The nebulized surfactant is a natural lyophilized bovine surfactant (Alveofact®) preparation with an approximate composition of phospholipids [phosphatidylcholine (75%), phosphatidylglycerol (13%), phosphatidylethanolamine (3%), phosphatidylinositol (1%) and sphingomyelin (1%)], cholesterol (5%), surfactant proteins (1% SP-B and SP-C), and very low levels of free fatty acids, lysophosphatidylcholine, water, and 0.13% calcium. Each Alveofact® lyophilized vial consists of 108 mg of surfactant mixed at the bedside with a prefilled syringe containing 2.2 ml of 0.45% saline buffer for administration into the nebulizer.