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|Effect of sustained inflations versus intermittent positive pressure ventilation on bronchopulmonary dysplasia or death among extremely preterm infants: the SAIL randomized clinical trial [with consumer summary]|
|Kirpalani H, Ratcliffe SJ, Keszler M, Davis PG, Foglia EE, te Pas A, Fernando M, Chaudhary A, Localio R, van Kaam AH, Onland W, Owen LS, Schmolzer GM, Katheria A, Hummler H, Lista G, Abbasi S, Klotz D, Simma B, Nadkarni V|
|JAMA 2019 Mar 26;321(12):1165-1175|
|7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*|
IMPORTANCE: 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 enrolment 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 cmH2O 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 versus 125 infants (59.2%) in the standard resuscitation group (adjusted risk difference (aRD) 4.7% (95% CI -3.8% to 13.1%); p = 0.29). Death at less than 48 hours of age occurred in 16 infants (7.4%) in the sustained inflation group versus 3 infants (1.4%) in the standard resuscitation group (aRD 5.6% (95% CI 2.1% to 9.1%); p = 0.002). 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. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02139800.