Randomized Trial Comparing 3 Approaches to the Initial Respiratory Management of Preterm Neonates

Dunn, Michael; Kaempf, Joseph W.; Klerk, Alan de; Klerk, Rose de; Reilly, Maureen; Howard, Diantha B.; Ferrelli, Karla; O'Conor, Jeanette; Soll, Roger F.

doi:10.1542/peds.2010-3848

Cited by 476 publications

(370 citation statements)

References 17 publications

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Section: Early Surfactant and Early Non-invasive Respiratory Supportsupporting

confidence: 56%

“…This method consists in intubation to instill exogenous surfactant and after that, extubation and connecting the patient to a non-invasive respiratory support. A reduction in mechanical ventilation needs has been shown in previous studies [11,12]. Some disadvantages about the INSURE method can be stated as follows: we are not completely avoiding intubation or mechanical ventilation, although they are used for a shorter time than in the classical method.…”

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confidence: 96%

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Minimally Invasive Surfactant Therapy: New Age

Candela¹

2015

J Neonatal Biol

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The BeginningDr. Von Neergaard first detected the surface tension in the gasliquid interphase and its role in the lung compliance in 1929, showing that more pressure was required to inflate lungs with air than with aqueous solution like water and concluding that retractile force of the lung was dependent on the surface tension in the alveoli [1]. To date, great advances in this field have been done. In 1959, Dr. Avery stablished the causal relationship between the hyaline membrane diseases in the premature infant with the absence of a substance that decreased the surface tension and so, increased the lung volume [2].After these discoveries, research study was headed for finding a way to create that foamy mix of proteins and fats called surfactant, but it was not until twenty years later, in 1980, when Dr. Fujiwara published the first clinical experience with exogenous surfactant, showing an improvement in oxygenation [3]. Ten years later the FDA approved the clinical use of this substance and contributed to the stunning advances in the prognosis of the premature infants with RDS, reducing air leak, oxygenation and neonatal death [4]. Nowadays trend about the management of neonatal RDS in the premature infant can be summarized in one main idea: the softer the management is, the better. With this concept in mind a new goal comes into view: avoiding intubation. This is the reason why the non-invasive respiratory support tries to become a substitute to intubation and mechanical ventilation when it is possible. This modality has shown a reduction in intubation, surfactant administration and non-significant reduction of death or bronchopulmonary dysplasia [RR 0.80 (CI 95% 0.58-1.12)] [8]. When comparing intubation and surfactant administration to non-invasive respiratory support, the latest is a valid alternative [9]. Type and DoseOn the other hand, newborns managed with non-invasive respiratory support, may need intubation and surfactant administration in a later phase of their evolution, and consequently, they cannot take advantage from the early surfactant therapy. This failure has been studied and estimated in 22% in the premature infants managed initially with this non-invasive support [10]. Early Surfactant and Early Non-Invasive Respiratory SupportBoth early surfactant and non-invasive respiratory support have shown benefits, so the next question should be which one is the best option. In this new age of softer management of preterm infants the question should turned into: why not using both?The option of giving surfactant reducing mechanical ventilation as much as possible is the INSURE technique (INtubate-SURfactantExtubate). This method consists in intubation to instill exogenous surfactant and after that, extubation and connecting the patient to a non-invasive respiratory support. A reduction in mechanical ventilation needs has been shown in previous studies [11,12]. Some disadvantages about the INSURE method can be stated as follows: we are not completely avoiding intubation or mechanical ventilation, alth...

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Section: Early Surfactant and Early Non-invasive Respiratory Supportsupporting

confidence: 56%

mentioning

confidence: 96%

Minimally Invasive Surfactant Therapy: New Age

Candela¹

2015

J Neonatal Biol

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“…5,6 The first intervention (CPAP versus DR intubation/surfactant) was unblinded, and its primary outcome was death or bronchopulmonary dysplasia at 36 weeks' postmenstrual age. 5 9 and neonates who received comfort care in the DR (death without endotracheal intubation), or had severe congenital anomalies. This GA range was selected because infants in this GA range are included in the 501 to 1500 g BW range of VON.…”

Section: Settingmentioning

confidence: 99%

Change in Care Among Nonenrolled Patients During and After a Randomized Trial

et al. 2013

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WHAT'S KNOWN ON THIS SUBJECT: Participating in a trial may affect processes of care by participating physicians; however, no study has assessed whether it affects processes of care for nonenrolled patients.WHAT THIS STUDY ADDS: Participation in a trial may affect processes of care for nonenrolled patients, even when care providers participating in or familiar with the trial protocol are unaware that data on nonenrolled patients are being collected for a study. weeks' gestational age (GA) were randomized in the delivery room (DR) to endotracheal intubation or nasal continuous positive airway pressure. We hypothesized that DR intubation could change in nonenrolled patients at PMH and that the change would be larger than in comparable centers not participating in the trial. METHODS:The PMH Cohort included eligible but nonenrolled neonates of 24 0/7 to 27 6/7 weeks (primary) and noneligible neonates of 28 to 34 6/7 weeks (confirmatory). A subset (24 0/7 -29 6/7 weeks) of that cohort was compared with a contemporaneous cohort born in centers participating in the Vermont Oxford Network (VON). We used a Poisson regression model to obtain adjusted relative risks (RRs) of DR intubation (during/after SUPPORT versus before SUPPORT) for PMH and for VON along with the ratio of these RRs. RESULTS:In the PMH cohort (n = 3527), the proportion of DR intubation decreased during/after SUPPORT in the lower GA group (adjusted RR 0.76, 95% confidence interval [CI] 0.59-0.96) and the upper GA group (adjusted RR 0.57, 95% CI 0.46-0.70). Compared with the RR for DR intubation in VON, the RR at PMH was smaller in the lower (ratio of RR 0.76, 95% CI 0.65-0.87) and the upper GA group (ratio of RR 0.52, 95% CI 0.39-0.68).CONCLUSIONS: A center' s participation in an unblinded randomized trial may affect process of care of nonenrolled patients. Pediatrics 2013;132:e960-e970 AUTHORS:

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“…2,3 The Vermont Oxford Group reports that CPAP started soon after birth is a strategy that reduces bronchopulmonary dysplasia and death while not showing any increased risk of adverse outcomes from delaying or eliminating surfactant administration. 3 In practice, bubble CPAP is commonly used initially as an inexpensive noninvasive mode of respiratory support that maintains lung volume to avoid intubation or for postextubation support. 4 Ms Bailes is affiliated with the Simulation Center of Safety and Reliability, Ms CPAP has been used as an intervention for infants experiencing respiratory distress for several decades.…”

Section: Introductionmentioning

confidence: 99%

Evaluating the Effect of Flow and Interface Type on Pressures Delivered With Bubble CPAP in a Simulated Model

Bailes

Firestone²,

Dunn³

et al. 2015

Respir Care

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BACKGROUND: Bubble CPAP, used for spontaneously breathing infants to avoid intubation or postextubation support, can be delivered with different interface types. This study compared the effect that interfaces had on CPAP delivery. We hypothesized that there would be no difference between set and measured levels between interface types. METHODS: A validated preterm infant nasal airway model was attached to the ASL 5000 breathing simulator. The simulator was programmed to deliver active breathing of a surfactant-deficient premature infant with breathing frequency at 70 breaths/min inspiratory time of 0.30 s, resistance of 150 cm H 2 O/L/s, compliance of 0.5 mL/cm H 2 O, tidal volume of 5 mL, and esophageal pressure of ؊10 cm H 2 O. Nasal CPAP prongs, size 4030, newborn and infant RAM cannulas were connected to a nasal airway model and a bubble CPAP system. CPAP levels were set at 4, 5, 6, 7, 8, and 9 cm H 2 O with flows of 6, 8, and 10 L/min each. Measurements were recorded after 1 min of stabilization. The analysis was performed using SAS 9.4. The Kolmogorov-Smirnov test assessed normality of the data. The Friedman test was used to compare non-normally distributed repeated measures. The Wilcoxon signed-rank test was used to conduct post hoc analysis. All tests were 2-sided, and P values of <.05 were considered as indicating significant differences unless otherwise indicated. RESULTS: At lower set CPAP levels, 4 -6 cm H 2 O, measured CPAP dropped precipitously with the nasal prongs with the highest flow setting. At higher CPAP levels, 7-9 cm H 2 O measured CPAP concomitantly increased as the flow setting increased. Statistically significant differences in set and measured CPAP occurred for all devices across all CPAP levels, with the measured CPAP less than set for all conditions, P < .001. CONCLUSIONS: Set flow had a profound effect on measured CPAP. The concomitant drop in measured pressure with high and low flows could be attributed to increased resistance to spontaneous breathing or insufficient flow to meet inspiratory demand. Clinicians should be aware of the effect that the interface and flow have on CPAP delivery.

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Randomized Trial Comparing 3 Approaches to the Initial Respiratory Management of Preterm Neonates

Cited by 476 publications

References 17 publications

Minimally Invasive Surfactant Therapy: New Age

Minimally Invasive Surfactant Therapy: New Age

Change in Care Among Nonenrolled Patients During and After a Randomized Trial

Evaluating the Effect of Flow and Interface Type on Pressures Delivered With Bubble CPAP in a Simulated Model

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