Randomized, multicenter trial of conventional ventilation versus high-frequency oscillatory ventilation for the early management of respiratory failure in term or near-term infants in Colombia.
OBJECTIVE
To determine the efficacy and safety of high-frequency oscillatory ventilation (HFOV) compared to conventional ventilation (CV) for the treatment of respiratory failure in term and near-term infants in Colombia.


METHODS
Eligible infants with moderate to severe respiratory failure were randomized to early treatment with CV or HFOV. Ventilator management and general patient care were standardized. The main outcome was neonatal death or pulmonary air leak.


RESULTS
A total of 119 infants were enrolled (55 in the HFOV group; 64 in the CV group) during the study period. Six infants in the HFOV group (11%) and two infants in the CV group (3%) developed the primary outcome (RR: 3.6, 95% CI: 0.8-16.9). Five infants in the HFOV group (9%) and one infant in the CV (2%) died before 28 days of life (RR: 5.9 CI: 0.7-48.2). Secondary outcomes were similar between groups.


CONCLUSIONS
HFOV may not be superior to CV as an early treatment for respiratory failure in this age group. Standardization of ventilator management and general patient care may have a greater impact on the outcome in Colombia than mode of ventilation.
Rojas
Mario A
MA
Department of Pediatrics, Vanderbilt University, Nashville, TN 37232-2370, USA.
Lozano
Juan M
JM
Rojas
María X
MX
Bose
Carl L
CL
Rondón
Martín A
MA
Ruiz
Gloria
G
Piñeros
Juan G
JG
Rojas
Catherine
C
Robayo
Guillermo
G
Hoyos
Angela
A
Celis
Luz Astrid
LA
Torres
Sergio
S
Correa
Janet
J
D006612:High-Frequency Ventilation; D006801:Humans; D007223:Infant; D012121:Respiration, Artificial; D012131:Respiratory Insufficiency / Q000628:therapy*; D016896:Treatment Outcome