A randomised trial of prophylactic oropharyngeal surfactant for preterm infants

Background: Preterm infants are at high risk of developing respiratory distress syndrome (RDS).
Endotracheal surfactant is effective in preventing and treating RDS; however, intubation is invasive
and associated with adverse effects. Half of infants born <29 weeks’ gestation initially managed with
continuous positive airway pressure (CPAP) are ultimately intubated for surfactant. Administration of
surfactant into the pharynx has been reported in preterm animals and humans and may be effective.
We wished to determine whether giving oropharyngeal surfactant at birth reduces the rate of
endotracheal intubation for respiratory failure in preterm infants within 120 hours.
Methods/design: Infants born before 29 weeks’ gestation who were free of major anomalies
were enrolled to this unblinded study at nine centres in six European countries. They were
randomly assigned to receive oropharyngeal surfactant at birth in addition to CPAP or CPAP
alone. The primary outcome was intubation within 120 h of birth, either for bradycardia and/or
apnoea despite respiratory support in the delivery room, or for pre-specified respiratory failure
criteria in the neonatal intensive care unit. Secondary outcomes included incidence of
mechanical ventilation, chronic lung disease, and death before hospital discharge.
Results: A total of 251 infants were included in the study; 126 infants were assigned to
oropharyngeal surfactant and 125 infants to control. The groups were well matched at study
entry; their mean (SD) gestational age was 26 (2) vs 26 (2) weeks, and their mean (SD) birth
weight was 874 (261) vs 851 (253) g respectively. There was no difference between groups in the
rate of intubation at 120 hours [79/126 (63) vs 81/125 (65)%, p = 0.793] (table). There were no
differences between the groups in the rate or duration of mechanical ventilation; the rates of
bronchopulmonary dysplasia, chronic lung disease, or postnatal steroid use; or in the rate of
death before hospital discharge.
Conclusion: Administration of surfactant into the oropharynx immediately after birth in
addition to CPAP compared to CPAP alone did not reduce the rate of intubation amongst infants
born before 29 weeks’ gestation in the first 5 days of life.