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

Rojas, Mario A.; Lozano, Juan Manuel; Rojas, María Ximena; Laughon, Matthew M.; Bose, Carl; Sepúlveda, Martín Alonso Rondón; Charry, Laura; Bastidas, Jaime; Pérez, Luis; Rojas, Catherine; Ovalle, Oscar; Celis, Luz Astrid; Garcia-Harker, Jorge E.; Jaramillo, Martha

doi:10.1542/peds.2007-3501

Cited by 201 publications

(155 citation statements)

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“…21,25 Previous studies using NCPAP as a primary mode of respiratory support or following extubation reported failures requiring intubation or reintubation. [9][10][11][12][13][14][15][16]29 These investigators used different types of nasal interfaces, such as single versus binasal prongs and different CPAP generators like bubble CPAP, infant flow drivers and conventional mechanical ventilators. CPAP failure rates by 3 to 7 days ranged from 19.7 to 80% in these studies.…”

Section: Discussionmentioning

confidence: 99%

Nasal intermittent positive pressure ventilation after surfactant treatment for respiratory distress syndrome in preterm infants <30 weeks’ gestation: a randomized, controlled trial

et al. 2012

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Objective: To compare the effect of early extubation to nasal intermittent positive pressure ventilation (NIPPV) versus nasal continuous positive airway pressure (NCPAP) on the need for mechanical ventilation via endotracheal tube (MVET) at 7 days of age in preterm infants <30 weeks' gestation requiring intubation and surfactant for respiratory distress syndrome (RDS) within 60 min of delivery.Study Design: Multicenter, randomized, controlled trial. A total of 57 infants were randomized within 120 min of birth to NCPAP (BW 1099 g and GA 27.8 weeks) and 53 infants to NIPPV (BW 1052 g, and GA 27.8 weeks). Infants were stabilized on NCPAP at birth and were given poractant alfa combined with MVET within 60 min of age. When stabilized on MVET, they were extubated within the next hours or days to NCPAP or NIPPV.Result: A total of 40% of infants needed MVET at 7 days of age in the NCPAP group compared with 17% in the NIPPV group (OR: 3.6; 95% CI: 1.5, 8.7). Days on MVET were 12±11 days in NCPAP group compared with 7.5 ± 12 days in the NIPPV group (median 1 vs 7 days; P ¼ 0.006). Clinical bronchopulmonary dysplasia (BPD) was 39% in the NCPAP group compared to 21% in the NIPPV group (OR: 2.4; 95% CI: 1.02, 5.6). Physiological BPD was 46% in the NCPAP group compared with 11% in the NIPPV group (OR: 6.6, 95% CI: 2.4, 17.8; P ¼ 0.001). There were no differences in any other outcomes between the two groups. Keywords: respiratory distress syndrome; surfactant; preterm; bronchopulmonary dysplasia; NIPPV; NCPAP Introduction Respiratory distress syndrome (RDS) is the most common respiratory morbidity in preterm infants. Surfactant therapy and mechanical ventilation have become the standard of care in preterm infants with RDS. Bronchopulmonary dysplasia (BPD) continues to remain a major morbidity among preterm very low birth weight infants despite the increasing use of antenatal steroids, surfactant therapy and significant advances in mechanical ventilation. 1-3 BPD is associated with both short-and long-term morbidities in very low birth weight infants. Factors associated with BPD include prolonged intubation, mechanical ventilation, barotrauma, volutrauma or oxygen-induced lung inflammation. 4 Early surfactant administration followed by extubation to nasal continuous positive airway pressure (NCPAP) or NCPAP alone without surfactant therapy have been shown to decrease the incidence of BPD in very low birth weight infants in observational studies. 5,6 Findings of a multicenter randomized controlled trial 7 investigating whether early versus late treatment with surfactant reduced the requirement of mechanical ventilation in very preterm infants primarily supported by NCPAP found that early surfactant treatment improved oxygenation 6 h after randomization and reduced the need for mechanical ventilation via endotracheal tube (MVET) before discharge from 68 to 25%. In addition, early surfactant administration followed by extubation to NCPAP in infants <30 weeks gestational age significantly decreased the need for MVET to 0% by 7 day...

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Section: Discussionmentioning

confidence: 99%

Nasal intermittent positive pressure ventilation after surfactant treatment for respiratory distress syndrome in preterm infants <30 weeks’ gestation: a randomized, controlled trial

et al. 2012

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“…Desde el 2008 se sabe que la incidencia de neumotórax se reduce con el uso temprano de surfactante en neonatos prematuros con síndrome de dificultad respiratoria (2,24).…”

Section: Discussionunclassified

“…En los últimos años se ha acumulado evidencia sobre cómo el apoyo respiratorio con presión positiva continua en la vía aérea (Continuous Positive Airway Pressure, CPAP), comparado con el uso de la respiración mecánica asistida convencional, es una alternativa eficaz, no invasiva y de bajo costo que, además, presenta cada vez menos complicaciones, por lo que su uso es cada vez más frecuente para reducir la displasia broncopulmonar, particularmente en países con recursos económicos limitados (2,3).…”

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“…En los metaanálisis publicados en los últimos años, que incluyen gran cantidad de estudios sobre intervenciones sin uso de surfactante, se concluye que: la CPAP reduce el tiempo de intervención de la enfermedad de membrana hialina; que es equivalente a la respiración mecánica en cuanto a mortalidad, presencia de enterocolitis necrosante y hemorragia intraventricular (con la ventaja de que puede usarse incluso en prematuros muy pequeños), y que la gravedad de la displasia broncopulmonar es menor, por lo que también se reduce el uso de oxígeno y esteroides (1,2,(4)(5)(6)(7)(8).…”

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“…Sin embargo, los ensayos clínicos y metaanálisis publicados hasta el momento no incluyen el efecto que tiene la aplicación de surfactante pulmonar en los resultados cuando se comparan la CPAP y la respiración mecánica asistida. Se encuentran estudios en los que se compara la CPAP sin administración de surfactante y la respiración mecánica asistida con surfactante, pero no así estudios que comparen estas dos estrategias empleadas con surfactante, por lo que existe la necesidad de llevarlos a cabo (2,(4)(5)(6)(7)(8), objetivo al que se abocó el presente estudio de cohorte.…”

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Nasal CPAP vs. mechanical ventilation in 28-32 weeks preterm infants with early surfactant administration

et al. 2014

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Association of Noninvasive Ventilation Strategies With Mortality and Bronchopulmonary Dysplasia Among Preterm Infants

Isayama

Iwami

McDonald

et al. 2016

JAMA

259

204

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IMPORTANCE Various noninvasive ventilation strategies are used to prevent bronchopulmonary dysplasia (BPD)of preterm infants; however, the best mode is uncertain.OBJECTIVE To compare 7 ventilation strategies for preterm infants including nasal continuous positive airway pressure (CPAP) alone, intubation and surfactant administration followed by immediate extubation (INSURE), less invasive surfactant administration (LISA), noninvasive intermittent positive pressure ventilation, nebulized surfactant administration, surfactant administration via laryngeal mask airway, and mechanical ventilation.DATA SOURCES MEDLINE, EMBASE, CINAHL, and Cochrane CENTRAL from their inceptions to June 2016. STUDY SELECTION Randomized clinical trials comparing ventilation strategies for infants younger than 33 weeks' gestational age within 24 hours of birth who had not been intubated.DATA EXTRACTION AND SYNTHESIS Data were independently extracted by 2 reviewers and synthesized with Bayesian random-effects network meta-analyses. MAIN OUTCOMES AND MEASURES A composite of death or BPD at 36 weeks' postmenstrual age was the primary outcome. Death, BPD, severe intraventricular hemorrhage, and air leak by discharge were the main secondary outcomes. RESULTSAmong 5598 infants involved in 30 trials, the incidence of the primary outcome was 33% (1665 of 4987; including 505 deaths and 1160 cases of BPD). The secondary outcomes ranged from 6% (314 of 5587) for air leak to 26% (1160 of 4455) for BPD . Compared with mechanical ventilation, LISA had a lower odds of the primary outcome (odds ratio [OR], 0.49; 95% credible interval [CrI], 0.30-0.79; absolute risk difference [RD], 164 fewer per 1000 infants; 57-253 fewer per 1000 infants; moderate quality of evidence), BPD(OR, 0.53; 95% CrI, 0.27-0.96; absolute RD, 133 fewer per 1000 infants; 95% CrI, 9-234 fewer per 1000 infants; moderate-quality), and severe intraventricular hemorrhage (OR, 0.44; 95% CrI, 0.19-0.99; absolute RD, 58 fewer per 1000 births; 95% CrI, 1-86 fewer per 1000 births; moderate-quality). Compared with nasal CPAP alone, LISA had a lower odds of the primary outcome (OR, 0.58; 95% CrI, 0.35-0.93; absolute RD, 112 fewer per 1000 births; 95% CrI, 16-190 fewer per 1000 births; moderate quality), and air leak (OR, 0.24; 95% CrI, 0.05-0.96; absolute RD, 47 fewer per 1000 births; 95% CrI, 2-59 fewer per 1000 births; very low quality). Ranking probabilities indicated that LISA was the best strategy with a surface under the cumulative ranking curve of 0.85 to 0.94, but this finding was not robust for death when limited to higher-quality evidence.CONCLUSIONS AND RELEVANCE Among preterm infants, the use of LISA was associated with the lowest likelihood of the composite outcome of death or BPD at 36 weeks' postmenstrual age. These findings were limited by the overall low quality of evidence and lack of robustness in higher-quality trials. INSURE intubation and surfactant administration followed by immediate extubation LISA less invasive surfactant administration NPPV noninvasive intermittent po...

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

Cited by 201 publications

References 24 publications

Nasal intermittent positive pressure ventilation after surfactant treatment for respiratory distress syndrome in preterm infants <30 weeks’ gestation: a randomized, controlled trial

Nasal intermittent positive pressure ventilation after surfactant treatment for respiratory distress syndrome in preterm infants <30 weeks’ gestation: a randomized, controlled trial

Nasal CPAP vs. mechanical ventilation in 28-32 weeks preterm infants with early surfactant administration

Association of Noninvasive Ventilation Strategies With Mortality and Bronchopulmonary Dysplasia Among Preterm Infants

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