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Application of continuous positive airway pressure in the delivery room: a multicenter randomized clinical trial.

ABSTRACT: This study evaluated whether the use of continuous positive airway pressure (CPAP) in the delivery room alters the need for mechanical ventilation and surfactant during the first 5 days of life and modifies the incidence of respiratory morbidity and mortality during the hospital stay. The study was a multicenter randomized clinical trial conducted in five public university hospitals in Brazil, from June 2008 to December 2009. Participants were 197 infants with birth weight of 1000-1500 g and without major birth defects. They were treated according to the guidelines of the American Academy of Pediatrics (APP). Infants not intubated or extubated less than 15 min after birth were randomized for two treatments, routine or CPAP, and were followed until hospital discharge. The routine (n=99) and CPAP (n=98) infants studied presented no statistically significant differences regarding birth characteristics, complications during the prenatal period, the need for mechanical ventilation during the first 5 days of life (19.2 vs 23.4%, P=0.50), use of surfactant (18.2 vs 17.3% P=0.92), or respiratory morbidity and mortality until discharge. The CPAP group required a greater number of doses of surfactant (1.5 vs 1.0, P=0.02). When CPAP was applied to the routine group, it was installed within a median time of 30 min. We found that CPAP applied less than 15 min after birth was not able to reduce the need for ventilator support and was associated with a higher number of doses of surfactant when compared to CPAP applied as clinically indicated within a median time of 30 min.

SUBMITTER: Goncalves-Ferri WA

PROVIDER: S-EPMC3982948 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

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Application of continuous positive airway pressure in the delivery room: a multicenter randomized clinical trial.

Gonçalves-Ferri W A WA Martinez F E FE Caldas J P S JP Marba S T M ST Fekete S S Rugolo L L Tanuri C C Leone C C Sancho G A GA Almeida M F B MF Guinsburg R R

Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas 20140129 3

This study evaluated whether the use of continuous positive airway pressure (CPAP) in the delivery room alters the need for mechanical ventilation and surfactant during the first 5 days of life and modifies the incidence of respiratory morbidity and mortality during the hospital stay. The study was a multicenter randomized clinical trial conducted in five public university hospitals in Brazil, from June 2008 to December 2009. Participants were 197 infants with birth weight of 1000-1500 g and wit ...[more]

PMID: 24554040

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Project description:Obstructive sleep apnea (OSA) is a serious and costly public health problem. The main medical treatment, continuous positive airway pressure, is efficacious when used, but poorly tolerated in up to 50% of patients. Upper airway reconstructive surgery is available when medical treatments fail but randomized trial evidence supporting its use is limited. This protocol details a randomized controlled trial designed to assess the clinical effectiveness, safety, and cost-effectiveness of a multilevel upper airway surgical procedure for OSA. A prospective, parallel-group, open label, randomized, controlled, multicenter clinical trial in adults with moderate or severe OSA who have failed or refused medical therapies. Six clinical sites in Australia randomly allocated participants in a 1:1 ratio to receive either an upper airway surgical procedure consisting of a modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction, or to continue with ongoing medical management, and followed them for 6 months. Primary outcomes: difference between groups in baseline-adjusted 6 month OSA severity (apnea-hypopnea index) and subjective sleepiness (Epworth Sleepiness Scale). Secondary outcomes: other OSA symptoms (e.g. snoring and objective sleepiness), other polysomnography parameters (e.g. arousal index and 4% oxygen desaturation index), quality of life, 24 hr ambulatory blood pressure, adverse events, and adherence to ongoing medical therapies (medical group). The Sleep Apnea Multilevel Surgery (SAMS) trial is of global public health importance for testing the effectiveness and safety of a multilevel surgical procedure for patients with OSA who have failed medical treatment. Multilevel airway surgery in patients with moderate-severe Obstructive Sleep Apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366019&isReview=true Australian New Zealand Clinical Trials Registry ACTRN12614000338662, prospectively registered on 31 March 2014.

Project description:To assess whether premedication with eszopiclone would improve sleep duration and continuity during polysomnography, thereby improving the quality of diagnostic and CPAP titration studies.Prospective, double-blinded, placebo-controlled trialAcademic, multidisciplinary sleep center.226 adult subjects undergoing polysomnography for suspected sleep disordered breathing; 113 received eszopiclone and 113 received placebo.Subjects received eszopiclone 3 mg or matching placebo before polysomnography. We compared sleep latency, efficiency, total sleep time, and apnea-hypopnea index between these groups. We also compared rates of inadequate studies, defined as insufficient sleep time (< 120 min or sleep efficiency < or = 70%) or incomplete CPAP titrations (> or = 5 events/h on the highest CPAP or complete intolerance).Eszopiclone premedication significantly improved a number of measured variables. Eszopiclone reduced sleep latency (21.7 +/- 27.1 vs. 32.6 +/- 38.2 min, P = 0.014), improved sleep efficiency (87.6% +/- 10.8% vs. 78.1% +/- 15.6%, P < 0.001), reduced wake after sleep onset (39.2 +/- 31.9 vs. 64.5 +/- 45.4 min, P <0.001) and prolonged sleep time (346.5 +/- 53.1 vs. 312.2 +/- 64.2 min, P < 0.001). Sleep efficiencies < or = 70% were more common with placebo than medication (21.2% vs. 7.1%, P = 0.004). Eszopiclone facilitated improved CPAP titrations with fewer residual events (5.7 +/- 10.3 vs. 11.9 +/- 19.6, P = 0.02) and fewer incomplete titrations (31.1% vs. 48.0%, P = 0.04). Poor quality studies (46.0% vs. 26.5%, P = 0.004) were more common with placebo than with eszopiclone. There was a trend for more non-usable studies with placebo (7.1% vs. 2.7%, P = 0.22). Side effects were uncommon and did not differ between groups.Pretreatment with eszopiclone improves the quality of polysomnography and CPAP titration and decreases the need to repeat studies. Given the ever-growing demand for polysomnography and the need to improve efficiency, the routine use of nonbenzodiazepines as premedication for polysomnography should be considered.

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Application of continuous positive airway pressure in the delivery room: a multicenter randomized clinical trial.

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Application of continuous positive airway pressure in the delivery room: a multicenter randomized clinical trial.

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