This multicentre, randomised, controlled parallel-group German trial assessed a new method of administering surfactant to spontaneously breathing preterm infants to avoid mechanical ventilation. Surfactant is normally administered via an endotracheal tube to mechanically ventilated preterm infants. The trial was conducted at 12 neonatal intensive care units in Germany between October, 2007, and January, 2010 and enrolled 220 preterm infants with a gestational age between 26 and 28 weeks and a birth weight less than 1.5 kg.

Infants were randomised (1:1 ratio) to standard treatment or intervention, and randomisation was stratified according to centre and multiple birth status. Infants were stabilised with continuous positive airway pressure (CPAP) and received rescue intubation if necessary. Infants in the standard treatment group (n= 112) were allocated to receive CPAP, rescue intubation, and surfactant treatment if needed. Infants in the in the intervention group (n = 108) received the same treatment as the standard group, but if infants were stable on CPAP and a fraction of inspired oxygen (FiO2) greater than 0•30 was needed, surfactant was given while the infant was breathing spontaneously. The surfactant was administered via a thin catheter inserted into the trachea by laryngoscopy. The primary endpoint measure considered in the study was need for any mechanical ventilation, or being not ventilated but having a partial pressure of carbon dioxide more than 65 mm Hg (8.6 kPa) or a fraction of inspired oxygen more than 0.60, or both, for more than 2 h between 25 h and 72 h of age. Analysis of the results was carried out on an intention to treat basis and all infants were analysed. The following findings are reported (direct from source):

• On day 2 or 3 after birth, 30 (28%) infants in the intervention group were mechanically ventilated versus 51 (46%) in the standard treatment group (number needed to treat 6, 95% CI 3-20, absolute risk reduction 0.18, 95% CI 0.30-0.05, p=0.008).

• 36 (33%) infants in the intervention group were mechanically ventilated during their stay in the hospital compared with 82 (73%) in the standard treatment group (number needed to treat: 3, 95% CI 2-4, p<0.0001).

• The intervention group had significantly fewer median days on mechanical ventilation, (0 days. IQR 0-3 vs. 2 days, 0-5) and a lower need for oxygen therapy at 28 days (30 infants [30%] vs. 49 infants [45%], p=0.032) compared with the standard treatment group.

• The authors recorded no differences between groups for mortality (seven deaths in the intervention group vs. five in the standard treatment group) and serious adverse events (21 vs. 28).

The authors discuss the limitations of their research, including that they could not mask the study intervention, which could have introduced bias into subsequent care through knowledge of randomisation. They conclude, “The application of surfactant via a thin catheter to spontaneously breathing preterm infants receiving continuous positive airway pressure reduces the need for mechanical ventilation.”

A related Comment article discusses the results of this study.