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

Vanderbilt University, Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Nashville, TN 37232-2370, USA.
PEDIATRICS (Impact Factor: 5.47). 02/2009; 123(1):137-42. DOI: 10.1542/peds.2007-3501
Source: PubMed


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.
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.
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.
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.
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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Available from: Catherine Rojas, Jan 02, 2014
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    ABSTRACT: Background: Nasal cannula, beside administering low-flow therapy, showed the capability for the administration of continuous positive airway pressure (CPAP) through high-flow nasal cannula (HFNC). Meeting specific physical criteria of 100% relative humidity (RH) and temperature of 37°C are the basic interventional requirements to administer oxygen for the newborns through a nasal cannula. Recently, two systems, MR850 and PMH7000, received the Food and Drug Administration (FDA) approval to administer heated, humidified HFNC (HHHFNC). These systems are evaluated in this study based on their humidifying and heating capabilities. Materials and Methods: This study was done as an RCT on newborns weighing 1,000 to 1,500 g recovering from respiratory distress syndrome (RDS) while nCPAP was administered at CDP = 4 cmH2O, Fio2 <30%. Patients were randomized to two groups of 35 receiving HHHFNC after treatment with nCPAP, with one group using MR850 humidifier and the other PMH7000. The patients were compared according to the duration of HHHFNC administration, repeated need for nCPAP respiratory support, the need for invasive ventilation, apnea, chronic lung disease (CLD), nasal trauma, RH, and temperature of the gases. Results: The average time of support with HHHNFC did not show any significant difference in the two groups. There was no significant difference between the groups in the need for nCPAP, invasive ventilation, apnea, nasal trauma, and CLD. The difference in the levels of average temperature and humidity was significant (P value <0.001). Conclusion: Although the records of temperature and RH in the PMH7000 system was lower than the records from the MR850 system, no clinical priority was observed for respiratory support with HHHNFC in the two systems.
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    • "Our data showed decrease of cholestasis in EP group, whereas Tan (23) reported no significant correlation between cholestasis and RDS. Our data demonstrated no difference between two groups regarding re-administration of PS in contrast with previous reports (24, 25), showing a decrease of re-administration of PS in the EP group. "
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    ABSTRACT: Pulmonary surfactant (PS) therapy was proven to be highly successful for the treatment of respiratory distress syndrome in premature infants. As a results, early prophylactic (EP) PS therapy has been introduced recently in Europe, the US and Korea. However, no multi-center study was compared EP and late selective (LS) PS therapies in Korea. We performed a retrospective multi-center study to compare the outcomes of EP and LS PS therapies in very preterm infants. We analyzed clinical morbidity and mortality for 1,291 infants in 2010 (LS group) and 1,249 infants in 2011 (EP group); the infants were born <30 weeks of gestation and had birth weight ≤1,250 g, and were chosen from 53 neonatal intensive care units in Korea. Compared to the LS group (22.5%), the overall mortality was better in the EP group (19.9%) and there was no increased need for retreatment.There were additional benefits in the EP group such as fewer associated complications. To the best of knowledge, our study is the first nationwide Korean study to compare the outcomes of EP and LS therapies, and it provides evidences that EP PS therapy is important in very preterm infants to improve for survival and reduce morbidities. Graphical Abstract
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    • "Need for FiO2 ≥0.7 to maintain oxygen saturation from 89 to 95%[23] "
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    ABSTRACT: Background: Surfactant administration together with nasal Continuous Positive Airway Pressure (nCPAP) administration is considered to be the basis for Newborn's Respiratory Distress Syndrome (RDS) management. This study evaluated the method of directing the surfactant to the lungs in newborns affiliated with RDS through i-gel (i-gel surfactant administration/i-gelSA) compared to the standard care INSURE method, in a clinical trial. Materials and Methods: This randomized control trial (RCT) was done on newborns weighing ≥2000 g, with RDS, while being supported with Bubble-CPAP. Newborns, which required FiO2 ≥0.3 under Continuous Distending Pressure (CDP) ≥5 cm H2O for more than 30 minutes to maintain SpO2 in the range of 89 - 95%, were given 100 mg/kg of Survanta. In the interventional group or the i-gelSA (i-gel Surfactant Administration) group, 35 newborns experienced surfactant administration with i-gel and 35 newborns in the control or INSURE group. The average a/APO2 before and after surfactant administration, repeated need for surfactant administration, average nCPAP duration, need for invasive mechanical ventilation, pneumothorax, and the average duration of hospitalization in the Neonatal Intensive Care Unit (NICU) were compared. Results: Although the average a/APO2 showed no significant difference before the procedure; in the i-gelSA group, this average was meaningfully higher after the administration of the surfactant (P = 0.001). The other factors showed no significant difference. Conclusion: According to the results of this study, the surfactant administration using i-gel was more successful in oxygenation improvement than the INSURE method, and the i-gel method could even be promoted to the standard care position. However, more research is needed in this area.
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