Sustained versus intermittent lung inflation for resuscitation of preterm infants: a randomized controlled trial

El-Chimi, Mohamed S.; Awad, H.H.; El-Gammasy, T Mohey; El-Farghali, Ola G.; Sallam, Mohamed T.H.; Shinkar, Dina M.

doi:10.1080/14767058.2016.1210598

Cited by 31 publications

(47 citation statements)

References 28 publications

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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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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

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

View full text Add to dashboard Cite

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“…However, clinical trials of SLI at birth in preterm infants have yielded conflicting results. In some studies, SLI significantly reduced the need for mechanical ventilation (MV), while other studies showed no reduction . A recent Cochrane review reported that there was insufficient evidence that SLI is superior to IPPV in terms of MV requirement and other important respiratory outcomes …”

Section: Introductionmentioning

confidence: 99%

“…Nearly all of the studies investigating the efficacy of SLI have used neonatal face‐masks as the interface . However, the use of neonatal face‐masks for both SLI and IPPV has been associated with significant air leakage or airway obstruction, thus reducing the effectiveness of the procedure .…”

Section: Introductionmentioning

confidence: 99%

Sustained lung inflation at birth via short binasal prong in very low birth weight preterm infants: A retrospective study

Büyüktiryaki

Kanmaz

Okur

et al. 2018

Pediatric Pulmonology

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Sustained Inflation vs Standard Resuscitation for Preterm Infants

et al. 2020

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IMPORTANCEMost preterm infants require respiratory support to establish lung aeration after birth. Intermittent positive pressure ventilation and continuous positive airway pressure are standard therapies. An initial sustained inflation (inflation time >5 seconds) is a widely practiced alternative strategy.OBJECTIVE To conduct a systematic review and meta-analysis of sustained inflation vs intermittent positive pressure ventilation and continuous positive airway pressure for the prevention of hospital mortality and morbidity for preterm infants.DATA SOURCES MEDLINE (through PubMed), Embase, the Cumulative Index of Nursing and Allied Health Literature, and the Cochrane Central Register of Controlled Trials were searched through June 24, 2019.STUDY SELECTION Randomized clinical trials of preterm infants born at less than 37 weeks' gestation that compared sustained inflation (inflation time >5 seconds) vs standard resuscitation with either intermittent positive pressure ventilation or continuous positive airway pressure were included. Studies including other cointerventions were excluded.DATA EXTRACTION AND SYNTHESIS Two reviewers assessed the risk of bias of included studies. Meta-analysis of pooled outcome data used a fixed-effects model specific to rarer events. Subgroups were based on gestational age and study design (rescue vs prophylactic sustained inflation). MAIN OUTCOMES AND MEASURES Death before hospital discharge.RESULTS Nine studies recruiting 1406 infants met inclusion criteria. Death before hospital discharge occurred in 85 of 736 infants (11.5%) treated with sustained inflation and 62 of 670 infants (9.3%) who received standard therapy for a risk difference of 3.6% (95% CI, −0.7% to 7.9%). Although analysis of the primary outcome identified important heterogeneity based on gestational age subgroups, the 95% CI for the risk difference included 0 for each individual gestational age subgroup. There was no difference in the primary outcome between subgroups based on study design. Sustained inflation was associated with increased risk of death in the first 2 days after birth (risk difference, 3.1%; 95% CI, 0.9%-5.3%). No differences in the risk of other secondary outcomes were identified. The quality-of-evidence assessment was low owing to risk of bias and imprecision. CONCLUSIONS AND RELEVANCEThere was no difference in the risk of the primary outcome of death before hospital discharge, and there was no evidence of efficacy for sustained inflation to prevent secondary outcomes. These findings do not support the routine use of sustained inflation for preterm infants after birth.

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Sustained versus intermittent lung inflation for resuscitation of preterm infants: a randomized controlled trial

Abstract: Delivery room SLI is more effective than intermittent bag and mask inflation for improving short-term respiratory outcome in preterm infants, without significant adverse effects.

Cited by 31 publications

References 28 publications

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

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

Sustained lung inflation at birth via short binasal prong in very low birth weight preterm infants: A retrospective study

Sustained Inflation vs Standard Resuscitation for Preterm Infants

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