Randomized Trial Comparing 3 Approaches to the Initial Respiratory Management of Preterm Neonates

AAP · 2011

A three-arm trial comparing prophylactic intubation and surfactant, intubation with surfactant followed by rapid extubation to CPAP, and initial CPAP with selective surfactant in very preterm infants. It helped establish delivery-room CPAP as a reasonable alternative to routine intubation, although it did not demonstrate a significant reduction in death or BPD.

Population

Infants born at 26 0/7 to 29 6/7 weeks of gestation

Intervention

Initial nasal CPAP, with surfactant given selectively if respiratory failure developed.

Comparators

Prophylactic surfactant + mechanical ventilation

Prophylactic surfactant + rapid extubation to CPAP (INSURE-type approach)

Outcome

Death or bronchopulmonary dysplasia (BPD) at 36 weeks PMA, along with respiratory and other neonatal outcomes.

Timeframe

Randomised in the delivery room; outcomes assessed during the neonatal hospitalization and at 36 weeks postmenstrual age.

Initial CPAP did not significantly reduce death or BPD compared with prophylactic surfactant followed by mechanical ventilation.

However, infants managed initially with CPAP had:

Less need for intubation

Less mechanical ventilation

Less surfactant administration

More infants remaining spontaneously breathing without immediate invasive ventilation

The three strategies had similar major clinical outcomes, including death or BPD.

The key result

The primary outcome—death or BPD at 36 weeks PMA—was not significantly different among the three groups.

The important finding was therefore not a statistically significant reduction in BPD, but the demonstration that many very preterm infants could be initially managed with CPAP without routine delivery-room intubation and prophylactic surfactant.

Where it is weak

The study included infants 26–29 weeks, so applicability to extremely preterm infants below 26 weeks is limited.

It was conducted in the era of less sophisticated non-invasive respiratory support than is available today.