NEW YORK (Reuters Health) – In a study of very low birth weight infants (VLBWIs), a strategy of prophylactic bubble continuous positive airway pressure (CPAP) followed by early selective surfactant using the INSURE protocol (intubation, surfactant, extubation) decreased the need for mechanical ventilation without increasing morbidity and death.

This finding, say the researchers, is particularly relevant for clinicians managing preterm neonates in the developing world, with few ventilators and a short supply of surfactant.

The study was conducted in 12 tertiary neonatal intensive care units from five South American countries (Argentina, Chile, Paraguay, Peru and Uruguay).

“Our findings demonstrate the feasibility of successfully using less invasive ventilator strategies in VLBWIs in our region,” the study team wrote online March 9 in The Journal of Pediatrics.

The study involved 256 spontaneously breathing neonates weighing 800 to 1500 g. Dr. Jose L. Tapia from Pontificia Universidad Catolica de Chile in Santiago and colleagues randomly allocated 131 to the CPAP/INSURE strategy and 125 to supplemental oxygen (administered via an oxyhood or low-flow nasal cannula), surfactant and mechanical ventilation if required (the Oxygen/MV group).

The authors explain: “In the CPAP/INSURE group, if respiratory distress syndrome (RDS) did not occur, CPAP was discontinued after 3-6 hours. If RDS developed and the fraction of inspired oxygen (FiO2) was >0.35, the INSURE protocol was indicated. In the Oxygen/MV group, in the presence of RDS, supplemental oxygen without CPAP was given, and if FiO2 was >0.35, surfactant and mechanical ventilation were provided.”

The two groups were well-matched for baseline characteristics.

According to the researchers, the CPAP/INSURE group had significantly lower rates of mechanical ventilation (29.8% vs 50.4%;p=0.001) and surfactant use (27.5% vs 46.4%;p=0.002).

There were no significant between-group differences in rates of death, pneumothorax, and bronchopulmonary dysplasia, but there were trends toward decreasing incidences of each.

Grade 3 to 4 intraventricular hemorrhage, patent ductus arteriosus, retinopathy of prematurity, necrotizing enterocolitis and sepsis occurred at similar rates in the two groups. Minor nasal lesions were found only in the CPAP/INSURE group (8.4%).

“Our study has several limitations,” the authors note. “This was not a blinded study, although management was rigidly defined in both groups. We enrolled only 55% of the total potential study population. One of the study’s strengths is the inclusion of infants from 12 diverse centers throughout South America.”

In an email to Reuters Health, Dr. Tapia concludes, “A less invasive strategy for the treatment of respiratory distress in the premature very low birth weight infant is safe and succeeds in decreasing the need for more invasive and expensive therapies as the use of mechanical ventilation and surfactant. This strategy could be applied in developing regions without adverse effects. This approach can become standard therapy in our region and elsewhere.”

SOURCE:

Randomized Trial of Early Bubble Continuous Positive Airway Pressure for Very Low Birth Weight Infants

J Pediatr 2012.