Published online December 29, 2008
PEDIATRICS Vol. 123 No. 1 January 2009, pp. 137-142 (doi:10.1542/peds.2007-3501)

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SPECIAL ARTICLE

Very Early Surfactant Without Mandatory Ventilation in Premature Infants Treated With Early Continuous Positive Airway Pressure: A Randomized, Controlled Trial

Mario Augusto Rojas, MD, MPH^a, Juan Manuel Lozano, MD, MSc^b, Maria Ximena Rojas, RN, MSc^b, Matthew Laughon, MD, MPH^c, Carl Lewis Bose, MD^c, Martin Alonso Rondon, MSc^b, Laura Charry, MD^b, Jaime Alberto Bastidas, MD^d, Luis Alfonso Perez, MD^e, Catherine Rojas, MD^f, Oscar Ovalle, MD^g, Luz Astrid Celis, MD^h, Jorge Garcia-Harker, MDⁱ, Martha Lucia Jaramillo, MD^j for the Colombian Neonatal Research Network

^a Department of Pediatrics, Vanderbilt University, Nashville, Tennessee
^b Department of Clinical Epidemiology and Biostatistics, Universidad Javeriana, Bogotá, Colombia
^c Department of Pediatrics, University of North Carolina, Chapel Hill, North Carolina
^d Clínica Los Farallones/Remedios, Cali, Colombia
^e Department of Pediatrics, Hospital Universitario de Santander, Bucaramanga, Colombia
^f Policlínico del Olaya, Bogotá, Colombia
^g Saludcoop, Bogotá, Colombia
^h Department of Pediatrics, Hospital Universitario Simón Bolivar, Bogotá, Colombia
ⁱ Clínica San Luis, Bucaramanga, Colombia
^j Fundación Valle de Lili, Cali, Colombia

BACKGROUND. Chronic lung disease is one of the most frequent and serious complications of premature birth. Because mechanical ventilation is a major risk factor for chronic lung disease, the early application of nasal continuous positive airway pressure has been used as a strategy for avoiding mechanical ventilation in premature infants. Surfactant therapy improves the short-term respiratory status of premature infants, but its use is traditionally limited to infants being mechanically ventilated. Administration of very early surfactant during a brief period of intubation to infants treated with nasal continuous positive airway pressure may improve their outcome and further decrease the need for mechanical ventilation.

OBJECTIVE. Our goal was to determine if very early surfactant therapy without mandatory ventilation improves outcome and decreases the need for mechanical ventilation when used in very premature infants treated with nasal continuous positive airway pressure soon after birth.

DESIGN/METHODS. Eight centers in Colombia participated in this randomized, controlled trial. Infants born between 27 and 31 weeks’ gestation with evidence of respiratory distress and treated with supplemental oxygen in the delivery room were randomly assigned within the first hour of life to intubation, very early surfactant, extubation, and nasal continuous positive airway pressure (treatment group) or nasal continuous airway pressure alone (control group). The primary outcome was the need for subsequent mechanical ventilation using predefined criteria.

RESULTS. From January 1, 2004, to December 31, 2006, 279 infants were randomly assigned, 141 to the treatment group and 138 to the control group. The need for mechanical ventilation was lower in the treatment group (26%) compared with the control group (39%). Air-leak syndrome occurred less frequently in the treatment group (2%) compared with the control group (9%). The percentage of patients receiving surfactant after the first hour of life was also significantly less in the treatment group (12%) compared with the control group (26%). The incidence of chronic lung disease (oxygen treatment at 36 weeks’ postmenstrual age) was 49% in the treatment group compared with 59% in the control group. All other outcomes, including mortality, intraventricular hemorrhage, and periventricular leukomalacia were similar between the groups.

CONCLUSIONS. In premature infants treated with nasal continuous positive airway pressure early after birth, the addition of very early surfactant therapy without mandatory ventilation decreased the need for subsequent mechanical ventilation, decreased the incidence of air-leak syndrome, and seemed to be safe. Reduction in the need for mechanical ventilation is an important outcome when medical resources are limited and may result in less chronic lung disease in both developed and developing countries.

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Key Words: very early surfactant • early nasal continuous positive airway pressure • respiratory distress syndrome • preterm infant • mandatory ventilation

Abbreviations: CLD—chronic lung disease • MV—mechanical ventilation • RDS—respiratory distress syndrome • NCPAP—nasal continuous positive airway pressure • FIO₂—fraction of inspired oxygen • SpO₂—pulse oximetry saturation • PPV—positive-pressure ventilation • PIE—pulmonary interstitial emphysema • IVH—intraventricular hemorrhage • PVL—periventricular leukomalacia • RR—relative risk • CI—confidence interval

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Accepted Mar 27, 2008.

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