Sustained lung inflation in late preterm infants: a randomized controlled trial

Mercadante, Domenica; Colnaghi, Mariarosa; Polimeni, Valentina; Ghezzi, E; Fumagalli, Monica; Consonni, Dario; Mosca, Fabio

doi:10.1038/jp.2015.222

Cited by 24 publications

(35 citation statements)

References 29 publications

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“…Two studies using a prophylactic approach with a fixed duration of SI [31,33] have shown a nonsignificant increase in the rate of pneumothorax from 1 to 6% (OR = 4.57; 95% CI: 0.97-21.5; p = 0.06) [31] and from 0 to 3% (p = 0.08) [33]. Only one more case was found in our study, despite the application of repeated SIs associated with much higher PEEPs.…”

Section: Discussioncontrasting

confidence: 68%

Feasibility of combining two individualized lung recruitment maneuvers at birth for very low gestational age infants: a retrospective cohort study

Kanaan

Bloch-Queyrat²,

Boubaya³

et al. 2020

BMC Pediatr

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Background: Lung recruitment at birth has been advocated as an effective method of improving the respiratory transition at birth. Sustained inflations (SI) and dynamic positive end-expiratory pressure (PEEP) were assessed in clinical and animal studies to define the optimal level. Our working hypothesis was that very low gestational age infants (VLGAI) < 32 weeks' gestation require an individualized lung recruitment based on combining both manoeuvers. Methods: Between 2014 and 2016, 91 and 72 inborn VLGAI, requiring a respiratory support beyond a continuous positive airway pressure (CPAP) = 5 cmH2O, were enrolled before and after introducing these manoeuvers based on progressive increase in SI up to 15 s, with simultaneous gradual increase in PEEP up to 15 cmH2O, according to the cardiorespiratory response. Retrospective comparisons of the incidence of mechanical ventilation (MV) < 72 h of life, short-term and before discharge morbidity were then performed.Results: Among extremely low gestational age infants (ELGAI) < 29 weeks' gestation, the following outcomes decreased significantly: intubation (90 to 55%) and surfactant administration (54 to 12%) in the delivery room, MV (92 to 71%) and its mean duration < 72 h of life (45 h to 13 h), administration of a 2nd dose of surfactant (35 to 12%) and postnatal corticosteroids (52 to 19%), and the rate of bronchopulmonary dysplasia (23 to 5%). Among VLGAI, all of these results were also significant. Neonatal mortality and morbidity were not different. Conclusions:In our setting, combining two individualized lung recruitment maneuvers at birth was feasible and may be beneficial on short-term and before discharge pulmonary outcomes. A randomized controlled trial is needed to confirm these results.

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Section: Discussioncontrasting

confidence: 68%

Feasibility of combining two individualized lung recruitment maneuvers at birth for very low gestational age infants: a retrospective cohort study

Kanaan

Bloch-Queyrat²,

Boubaya³

et al. 2020

BMC Pediatr

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“…Sustained inflation is currently standard practice in parts of Europe 9 based on studies in animals, asphyxiated term infants, 4 and smaller human randomized clinical trials in both preterm and near-term infants. 7,8,[27][28][29][30][31][32][33][34][35] Previous studies showed a reduction in mechanical ventilation within the first 72 hours of life 27,28 in infants receiving sustained inflation. Two meta-analyses 7,8 found a short-term benefit of sustained inflation, but a Cochrane review 8 suggested caution in interpretation of pooled analyses, noting marked interstudy heterogeneity.…”

Section: Discussionmentioning

confidence: 99%

“…Two meta-analyses 7,8 found a short-term benefit of sustained inflation, but a Cochrane review 8 suggested caution in interpretation of pooled analyses, noting marked interstudy heterogeneity. Prior smaller studies included more mature infants, 27,[31][32][33][34][35] involved shorter inspiratory durations, 29 reported surrogate outcomes, 29,35 had important co-interventions, 27 or were stopped early for futility. 30 This trial used sustained in-flations with peak pressures that were similar to prior studies 27,28,30 and durations similar to some.…”

Section: Discussionmentioning

confidence: 99%

“…36 Prior studies included infants likely to be breathing spontaneously. 27,28,[33][34][35] The early deaths were predominantly in the smallest, most vulnerable infants. Supporting transition at birth in the most immature infants may require gentler support than Covariates adjusted for were gestational age, site, infant sex, maternal corticosteroid use, initial heart rate, small for gestational age (except where indicated with tablenote "f"), and consent type used.…”

Section: Discussionmentioning

confidence: 99%

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Effect of Sustained Inflations vs Intermittent Positive Pressure Ventilation on Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants

Kirpalani

Ratcliffe

Keszler

et al. 2019

JAMA

149

152

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Preterm infants must establish regular respirations at delivery. Sustained inflations may establish lung volume faster than short inflations. OBJECTIVE To determine whether a ventilation strategy including sustained inflations, compared with standard intermittent positive pressure ventilation, reduces bronchopulmonary dysplasia (BPD) or death at 36 weeks' postmenstrual age without harm in extremely preterm infants. DESIGN, SETTING, AND PARTICIPANTS Unmasked, randomized clinical trial (August 2014 to September 2017, with follow-up to February 15, 2018) conducted in 18 neonatal intensive care units in 9 countries. Preterm infants 23 to 26 weeks' gestational age requiring resuscitation with inadequate respiratory effort or bradycardia were enrolled. Planned enrollment was 600 infants. The trial was stopped after enrolling 426 infants, following a prespecified review of adverse outcomes. INTERVENTIONS The experimental intervention was up to 2 sustained inflations at maximal peak pressure of 25 cm H 2 O for 15 seconds using a T-piece and mask (n = 215); standard resuscitation was intermittent positive pressure ventilation (n = 211). MAIN OUTCOME AND MEASURES The primary outcome was the rate of BPD or death at 36 weeks' postmenstrual age. There were 27 prespecified secondary efficacy outcomes and 7 safety outcomes, including death at less than 48 hours. RESULTS Among 460 infants randomized (mean [SD] gestational age, 25.30 [0.97] weeks; 50.2% female), 426 infants (92.6%) completed the trial. In the sustained inflation group, 137 infants (63.7%) died or survived with BPD vs 125 infants (59.2%) in the standard resuscitation group (adjusted risk difference [aRD], 4.7% [95% CI, −3.8% to 13.1%]; P = .29). Death at less than 48 hours of age occurred in 16 infants (7.4%) in the sustained inflation group vs 3 infants (1.4%) in the standard resuscitation group (aRD, 5.6% [95% CI, 2.1% to 9.1%]; P = .002). Blinded adjudication detected an imbalance of rates of early death possibly attributable to resuscitation (sustained inflation: 11/16; standard resuscitation: 1/3). Of 27 secondary efficacy outcomes assessed by 36 weeks' postmenstrual age, 26 showed no significant difference between groups. CONCLUSIONS AND RELEVANCE Among extremely preterm infants requiring resuscitation at birth, a ventilation strategy involving 2 sustained inflations, compared with standard intermittent positive pressure ventilation, did not reduce the risk of BPD or death at 36 weeks' postmenstrual age. These findings do not support the use of ventilation with sustained inflations among extremely preterm infants, although early termination of the trial limits definitive conclusions.

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“…Among those born < 28 weeks of gestational age, there was a lower need for intubation in the group that received a sustained inflation (29% vs 63%, p = 0.05), but this was not a pre-specified analysis [ 20 ]. In contrast to those promising results in moderately or extremely prematurely born infants, in infants born at 34–36 weeks of gestational age there were no significant differences in the need for respiratory support, the incidence of neonatal intensive care unit (NICU) admission for respiratory distress or the total length of NICU stay between infants who received a 15-s sustained inflation and those who received standard resuscitation according to the American Association of Pediatrics guidelines (drying, stimulation and, if inadequate respiratory effort or a heart rate < 100 bpm, positive pressure ventilation at 40–60 inflations per minute) [ 21 ].…”

Section: Introductionmentioning

confidence: 99%

Sustained inflations versus UK standard inflations during initial resuscitation of prematurely born infants in the delivery room: a study protocol for a randomised controlled trial

Hunt

Ali

Dassios

et al. 2017

Trials

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BackgroundMany infants born at less than 34 weeks of gestational age will require resuscitation in the delivery suite. Yet, different resuscitation techniques are specified in different national guidelines, likely reflecting a limited evidence base. One difference is the length of mechanical inflation initially delivered to infants either via a facemask or endotracheal tube. Some guidelines specify short inflations delivered at rates of 40–60/min, others recommend initial inflations lasting 2–3 s or sustained inflations lasting for ≥ 5 s for initial resuscitation. Research has shown that tidal volumes > 2.2 mL/kg (the anatomical dead space) are seldom generated unless the infant’s respiratory effort coincides with an inflation (active inflation). When inflations lasting 1–3 s were used, the time to the first active inflation was inversely proportional to the inflation time. This trial investigates whether a sustained inflation or repeated shorter inflations is more effective in stimulating the first active inflation.MethodsThis non-blinded, randomised controlled trial performed at a single tertiary neonatal unit is recruiting 40 infants born at < 34 weeks of gestational age. A 15-s sustained inflation is being compared to five repeated inflations of 2–3 s during the resuscitation at delivery. A respiratory function monitor is used to record airway pressure, flow, expiratory tidal volume and end tidal carbon dioxide (ETCO2) levels. The study is performed as emergency research without prior consent and was approved by the NHS London-Riverside Research Ethics Committee. The primary outcome is the minute volume in the first minute of resuscitation with secondary outcomes of the time to the first active inflation and ETCO2 level during the first minute of recorded resuscitation.DiscussionThis is the first study to compare a sustained inflation to the current UK practice of five initial inflations of 2–3 s.Trial registrationClinicalTrials.gov, NCT02967562. Registered on 15 November 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2311-y) contains supplementary material, which is available to authorized users.

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Sustained lung inflation in late preterm infants: a randomized controlled trial

Cited by 24 publications

References 29 publications

Feasibility of combining two individualized lung recruitment maneuvers at birth for very low gestational age infants: a retrospective cohort study

Feasibility of combining two individualized lung recruitment maneuvers at birth for very low gestational age infants: a retrospective cohort study

Effect of Sustained Inflations vs Intermittent Positive Pressure Ventilation on Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants

Sustained inflations versus UK standard inflations during initial resuscitation of prematurely born infants in the delivery room: a study protocol for a randomised controlled trial

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