Dataset Information

Effect of Sustained Inflations vs Intermittent Positive Pressure Ventilation on Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants: The SAIL Randomized Clinical Trial.

ABSTRACT: 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 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 H2O 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. Trial Registration:clinicaltrials.gov Identifier: NCT02139800.

SUBMITTER: Kirpalani H

PROVIDER: S-EPMC6439695 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Effect of Sustained Inflations vs Intermittent Positive Pressure Ventilation on Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants: The SAIL Randomized Clinical Trial.

Kirpalani Haresh H Ratcliffe Sarah J SJ Keszler Martin M Davis Peter G PG Foglia Elizabeth E EE Te Pas Arjan A Fernando Melissa M Chaudhary Aasma A Localio Russell R van Kaam Anton H AH Onland Wes W Owen Louise S LS Schmölzer Georg M GM Katheria Anup A Hummler Helmut H Lista Gianluca G Abbasi Soraya S Klotz Daniel D Simma Burkhard B Nadkarni Vinay V Poulain Francis R FR Donn Steven M SM Kim Han-Suk HS Park Won Soon WS Cadet Claudia C Kong Juin Yee JY Smith Alexandra A Guillen Ursula U Liley Helen G HG Hopper Andrew O AO Tamura Masanori M

JAMA 20190301 12

<h4>Importance</h4>Preterm infants must establish regular respirations at delivery. Sustained inflations may establish lung volume faster than short inflations.<h4>Objective</h4>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.<h4>Design, setting, and participants</h4>Unmasked, rand ...[more]

PMID: 30912836

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Project description:Background: Infants born extremely preterm are at high risk of developing bronchopulmonary dysplasia (BPD). This study aimed to assess the incremental health care burden of BPD and associated comorbidities among extremely preterm infants in the United States. Methods: Health service claims in the Premier Perspective database were retrospectively analyzed for infants born at ?28 weeks gestation who were admitted to neonatal intensive care during birth hospitalization and survived to a postmenstrual age of ?36 weeks. Gestational age (GA) at birth and BPD status of infants was determined based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes recorded in the database. Results: Of the 12,017 infants included, 4,904 (40.8%) had BPD. BPD increased with decreasing GA: 67.4% of infants born at <24 weeks GA had BPD vs. 28.7% of those born at 27-28 weeks. Infants with BPD had significantly longer hospital stays following birth than those without (mean [standard deviation (SD)] 102 [34] vs. 83 [24] days, respectively, P < 0.001), and incurred higher total charges (mean [SD] $799,499 [$535,528] vs. $588,949 [$377,137], respectively, P < 0.001). Mean total charges incurred during index hospitalization decreased as GA at birth increased, with GA having a bigger effect than presence or absence of BPD. During their first year, infants with BPD had a higher in-hospital late mortality rate than those without (1.9 vs. 0.6%), and were more likely to have two or more hospital encounters following birth hospitalization (58.0 vs. 48.2%). Among infants who had two or more encounters after discharge, those with BPD experienced a higher percentage of pulmonary symptoms than those without (46.3 vs. 38.9%). Comparison with infants who did not have BPD, retinopathy of prematurity, or intraventricular hemorrhage showed that BPD is the main complication contributing to increased length of stay, costs, in-hospital mortality, and additional health care encounters. Conclusion: BPD is a key contributor to the large health care burden associated with extremely preterm birth. However, GA at birth has a bigger effect on health care costs for extremely preterm infants than the presence of BPD.

Project description:BACKGROUND:The relation between mechanical ventilation (MV) and bronchopulmonary dysplasia (BPD) - a common disease in extremely premature newborn (PTNB) - is well stabilished, but is unknown, however, how much time under MV influences the severity of the disease. AIM:To define the duration under MV with greater chance to develop moderate to severe BPD in extremely PTNB and to compare clinical outcomes before and during hospitalization among patients with mild and moderate to severe BPD. METHODS:Fifty-three PTNB were separated into mild and moderate to severe BPD groups and their data were analyzed. Time under MV with a greater chance of developing moderate to severe BPD was estimated by the ROC curve. Perinatal and hospitalization outcomes were compared between groups. A logistic regression was performed to verify the influence of variables associated to moderate to severe BPD development, such as pulmonary hypertension (PH), gender, gestational age (GA) and weight at birth, as well the time under MV found with ROC curve. The result of ROC curve was validated using an independent sample (n =?16) by Chi-square test. RESULTS:Time under MV related to a greater chance of developing moderate to severe BPD was 36?days. Moderate to severe BPD group had more males (14 vs 5, p =?0,047), longer time under MV (43 vs 19?days, p <?0,001), more individuals with PH (12 vs 3, p =?0,016), worse retinopathy of prematurity (grade 3, 2 vs 11, p =?0,003), longer hospital length of stay (109 vs 81,5?days, p <?0,001), greater PMA (41 vs 38?weeks, p <?0,001) and weight (2620 vs 2031?g, p <?0,001) at discharge and the mild BPD group had more CPAP use prior to MV (12 vs 7, p =?0,043). Among all variables included in logistic regression, only PH and MV?<?36?days were significant in the model, explaining 72% of variation in moderate to severe BPD development. In the validation sample, prevalence of preterm infants who needed MV for more than 36?days in the moderate to severe BPD group was 100% (n =?6) and 0% in mild BPD group (p =?0,0001). CONCLUSION:Time under MV related to moderate to severe BPD development is 36?days, and worst outcomes are related to disease severity. PH and time under MV for more than 36?days are related to development of moderate to severe BPD.

Dataset Information

Effect of Sustained Inflations vs Intermittent Positive Pressure Ventilation on Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants: The SAIL Randomized Clinical Trial.

Publications

Effect of Sustained Inflations vs Intermittent Positive Pressure Ventilation on Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants: The SAIL Randomized Clinical Trial.

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