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: 5.3). 02/2009; 123(1):137-42. DOI: 10.1542/peds.2007-3501
Source: PubMed

ABSTRACT 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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    • "Nasal continuous positive airway pressure (NCPAP) has been advocated to be a gentler form of respiratory support that makes it possible to reduce the need for MV in preterm infants [1] [2] [3]. NCPAP combined with early surfactant replacement therapy, administered by intubation and rapid extubation (intubation-surfactantextubation , INSURE), has been introduced as a primary mode of respiratory support in premature infants with RDS with a varying degree of success, depending on patients' gestational age (GA) and the severity of the radiological stage of RDS and FiO 2 at surfactant administration [4] [5] [6] [7] [8] [9] [10]. An evidence-based review showed that surfactant given at an early stage of RDS with extubation to NCPAP, compared with "
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    ABSTRACT: Aim. To evaluate whether synchronized-NIPPV (SNIPPV) used after the INSURE procedure can reduce mechanical ventilation (MV) need in preterm infants with RDS more effectively than NCPAP and to compare the clinical course and the incidence of short-term outcomes of infants managed with SNIPPV or NCPAP. Methods. Chart data of inborn infants <32 weeks undergoing INSURE approach in the period January 2009-December 2010 were reviewed. After INSURE, newborns born January -December 2009 received NCPAP, whereas those born January-December 2010 received SNIPPV. INSURE failure was defined as FiO(2) need >0.4, respiratory acidosis, or intractable apnoea that occurred within 72 hours of surfactant administration. Results. Eleven out of 31 (35.5%) infants in the NCPAP group and 2 out of 33 (6.1%) infants in the SNIPPV group failed the INSURE approach and underwent MV (P < 0.004). Fewer infants in the INSURE/SNIPPV group needed a second dose of surfactant, a high caffeine maintenance dose, and pharmacological treatment for PDA. Differences in O(2) dependency at 28 days and 36 weeks of postmenstrual age were at the limit of significance in favor of SNIPPV treated infants. Conclusions. SNIPPV use after INSURE technique in our NICU reduced MV need and favorably affected short-term morbidities of our premature infants.
    Critical care research and practice 11/2012; 2012:301818. DOI:10.1155/2012/301818
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    • "This is a nested case-control study based on data collected as part of a multicenter randomized controlled trial carried out by the Colombian Neonatal Research Network in eight neonatal intensive care units (NICUs) located in three cities (Bogotá, Bucaramanga, and Cali) in Colombia. A detailed description of this trial has been published [20]. Briefly, premature infants born between 27 and 31 weeks of gestation with clinical evidence of respiratory distress during the first hour of life, and who did not require intubation as part of their initial resuscitation and stabilization, were placed on bubble nCPAP and then randomized to receive very early surfactant therapy through transient intubation followed by nCPAP or to expectant management on nCPAP alone. "
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    ABSTRACT: Background. An abnormally high incidence (44%) of bronchopulmonary dysplasia with variations in rates among cities was observed in Colombia among premature infants. Objective. To identify risk factors that could explain the observed high incidence and regional variations of bronchopulmonary dysplasia. Study Design. A case-control study was designed for testing the hypothesis that differences in the disease rates were not explained by differences in city-of-birth specific population characteristics or by differences in respiratory management practices in the first 7 days of life, among cities. Results. Multivariate analysis showed that premature rupture of membranes, exposure to mechanical ventilation after received nasal CPAP, no surfactant exposure, use of rescue surfactant (instead of early surfactant), PDA, sepsis and the median daily FIO(2), were associated with a higher risk of dysplasia. Significant differences between cases and controls were found among cities. Models exploring for associations between city of birth and dysplasia showed that being born in the highest altitude city (Bogotá) was associated with a higher risk of dysplasia (OR 1.82 95% CI 1.31-2.53). Conclusions. Bronchopulmonary dysplasia was manly explained by traditional risk factors. Findings suggest that altitude may play an important role in the development of this disease. Prenatal steroids did not appear to be protective at high altitude.
    07/2012; 2012:685151. DOI:10.5402/2012/685151
    • "(26%) in randomized controlled trials comparing the effectiveness of INSURE versus NCPAP alone. These differences are likely due to the higher severity of RDS [8] [9], different kind and dosage of surfactant, and less restrictive criteria applied to start MV [6] [10] compared with our study. "
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    ABSTRACT: The INSURE method, which consists of an intubation-surfactant-extubation sequence, is effective in reducing the need for mechanical ventilation (MV), the duration of respiratory support, and the need for surfactant replacement in preterm infants with respiratory distress syndrome. Although beneficial, the INSURE method fails to avoid MV in selected patients. We demonstrated that body weight <750 g, pO(2)/FiO(2) <218, and a/ApO(2) <0.44 at the first blood gas analysis are independent risk factors for INSURE failure in infants with gestational age <30 weeks. Moreover, we demonstrated that the INSURE treatment can be safely repeated with the aim to avoid MV, since the respiratory outcome did not differ between infants treated with single or multiple INSURE procedures.
    Early human development 01/2012; 88 Suppl 1(supplement 1):S3-4. DOI:10.1016/j.earlhumdev.2011.12.019 · 1.93 Impact Factor
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