Randomised controlled trial of sustained lung inflation for resuscitation of preterm infants in the delivery room

Jiravisitkul, Paveewan; Rattanasiri, Sasivimol; Nuntnarumit, Pracha

doi:10.1016/j.resuscitation.2016.12.003

Cited by 32 publications

(52 citation statements)

References 32 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%

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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%

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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“…inflations arms, 1-3 sustained inflations at a duration of 5-20 s and a pressure of 20-30 cmH 2 O were applied (table 1) [11,12,[17][18][19][20]. With regard to avoiding eMV, nine RCTs were included.…”

Section: Included Studiesmentioning

confidence: 99%

“…Only two RCTs in the sustained inflations meta-analysis prescribed a blinded outcome assessment (low risk/detection bias) [12,20]. Minor issues in several studies were the incomplete description of random sequence generation (unclear risk/selection bias) [17-19, 23, 24, 27], late or no registration of the study protocol (unclear risk/reporting bias) [11,18,19,22,27,28], and the use of respiratory distress as a study entry criterion (unclear risk/sampling bias) [13,21,22,26,28]. Other risks of bias in individual studies and the support for the current review authors' judgements are described in the supplementary material.…”

Section: Risk Of Bias In the Included Studiesmentioning

confidence: 99%

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Sustained inflations and avoiding mechanical ventilation to prevent death or bronchopulmonary dysplasia: a meta-analysis

et al. 2018

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Sustained inflations and avoidance of endotracheal mechanical ventilation (eMV) are delivery room interventions aimed at preventing bronchopulmonary dysplasia (BPD). Their effectiveness is the subject of the present meta-analysis.The databases MEDLINE, EMBASE and CENTRAL were searched for randomised controlled trials (RCTs) of preterm infants that compared: 1) sustained inflations with intermittent positive-pressure ventilation; and 2) a non-intubated strategy of respiratory support with one that prescribed eMV at an earlier stage. Data extraction and analysis followed the standard methods of the Cochrane Collaboration. The primary outcome was death or BPD, defined as need for oxygen or positive pressure treatment at 36 weeks' postmenstrual age.Avoiding eMV (nine RCTs, 3486 infants) reduced the risk of death or BPD, with a risk ratio of 0.90 (95% CI 0.84–0.97) and a number needed to treat of 35. After sustained inflations (six RCTs, 854 infants), the risk ratio was 0.85 (95% CI 0.65–1.12). A current multicentre RCT of sustained inflations in very preterm infants was halted for increased early mortality in the sustained inflations arm.While strategies aimed at avoiding eMV had a small but significant impact on preventing BPD, sustained inflations had no effect and may even increase mortality in very preterm infants.

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Interventions to Reduce Severe Brain Injury Risk in Preterm Neonates

et al. 2023

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ImportanceInterventions to reduce severe brain injury risk are the prime focus in neonatal clinical trials.ObjectiveTo evaluate multiple perinatal interventions across clinical settings for reducing the risk of severe intraventricular hemorrhage (sIVH) and cystic periventricular leukomalacia (cPVL) in preterm neonates.Data SourcesMEDLINE, Embase, CENTRAL (Cochrane Central Register of Controlled Trials), and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases were searched from inception until September 8, 2022, using prespecified search terms and no language restrictions.Study SelectionRandomized clinical trials (RCTs) that evaluated perinatal interventions, chosen a priori, and reported 1 or more outcomes (sIVH, cPVL, and severe brain injury) were included.Data Extraction and SynthesisTwo co-authors independently extracted the data, assessed the quality of the trials, and evaluated the certainty of the evidence using the Cochrane GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) approach. Fixed-effects pairwise meta-analysis was used for data synthesis.Main Outcomes and MeasuresThe 3 prespecified outcomes were sIVH, cPVL, and severe brain injury.ResultsA total of 221 RCTs that assessed 44 perinatal interventions (6 antenatal, 6 delivery room, and 32 neonatal) were included. Meta-analysis showed with moderate certainty that antenatal corticosteroids were associated with small reduction in sIVH risk (risk ratio [RR], 0.54 [95% CI, 0.35-0.82]; absolute risk difference [ARD], −1% [95% CI, −2% to 0%]; number needed to treat [NNT], 80 [95% CI, 48-232]), whereas indomethacin prophylaxis was associated with moderate reduction in sIVH risk (RR, 0.64 [95% CI, 0.52-0.79]; ARD, −5% [95% CI, −8% to −3%]; NNT, 20 [95% CI, 13-39]). Similarly, the meta-analysis showed with low certainty that volume-targeted ventilation was associated with large reduction in risk of sIVH (RR, 0.51 [95% CI, 0.36-0.72]; ARD, −9% [95% CI, −13% to −5%]; NNT, 11 [95% CI, 7-23]). Additionally, early erythropoiesis-stimulating agents (RR, 0.68 [95% CI, 0.57-0.83]; ARD, −3% [95% CI, −4% to −1%]; NNT, 34 [95% CI, 22-67]) and prophylactic ethamsylate (RR, 0.68 [95% CI, 0.48-0.97]; ARD, −4% [95% CI, −7% to 0%]; NNT, 26 [95% CI, 13-372]) were associated with moderate reduction in sIVH risk (low certainty). The meta-analysis also showed with low certainty that compared with delayed cord clamping, umbilical cord milking was associated with a moderate increase in sIVH risk (RR, 1.82 [95% CI, 1.03-3.21]; ARD, 3% [95% CI, 0%-6%]; NNT, −30 [95% CI, −368 to −16]).Conclusions and RelevanceResults of this study suggest that a few interventions, including antenatal corticosteroids and indomethacin prophylaxis, were associated with reduction in sIVH risk (moderate certainty), and volume-targeted ventilation, early erythropoiesis-stimulating agents, and prophylactic ethamsylate were associated with reduction in sIVH risk (low certainty) in preterm neonates. However, clinicians should carefully consider all of the critical factors that may affect applicability in these interventions, including certainty of the evidence, before applying them to clinical practice.

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Randomised controlled trial of sustained lung inflation for resuscitation of preterm infants in the delivery room

Cited by 32 publications

References 32 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 inflations and avoiding mechanical ventilation to prevent death or bronchopulmonary dysplasia: a meta-analysis

Interventions to Reduce Severe Brain Injury Risk in Preterm Neonates

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