In this prospective, randomized controlled study, nHFOV significantly reduced the need for IMV as compared with nCPAP in preterm infants with moderate-severe RDS without increase in adverse effects.

for the Nasal Oscillation Post-Extubation (NASONE) Study Group IMPORTANCE Several respiratory support techniques are available to minimize the use of invasive mechanical ventilation (IMV) in preterm neonates. It is unknown whether noninvasive high-frequency oscillatory ventilation (NHFOV) is more efficacious than nasal continuous positive airway pressure (NCPAP) or nasal intermittent positive pressure ventilation (NIPPV) in preterm neonates after their first extubation.OBJECTIVE To test the hypothesis that NHFOV is more efficacious than NCPAP or NIPPV in reducing IMV after extubation and until neonatal intensive care unit discharge among preterm neonates. DESIGN, SETTING, AND PARTICIPANTSThis multicenter, pathophysiology-based, assessor-blinded, 3-group, randomized clinical trial was conducted in 69 tertiary referral neonatal intensive care units in China, recruiting participants from December 1, 2017, to May 31, 2021. Preterm neonates who were between the gestational age of 25 weeks plus 0 days and 32 weeks plus 6 days and were ready to be extubated were randomized to receive NCPAP, NIPPV or NHFOV. Data were analyzed on an intention-to-treat basis. INTERVENTIONSThe NCPAP, NIPPV, or NHFOV treatment was initiated after the first extubation and lasted until discharge.MAIN OUTCOMES AND MEASURES Primary outcomes were total duration of IMV, need for reintubation, and ventilator-free days. These outcomes were chosen to describe the effect of noninvasive ventilation strategy on the general need for IMV.RESULTS A total of 1440 neonates (mean [SD] age at birth, 29.4 [1.8] weeks; 860 boys [59.7%]) were included in the trial. Duration of IMV was longer in NIPPV (mean difference, 1.2; 95% CI, 0.01-2.3 days; P = .04) and NCPAP (mean difference, 1.5 days; 95% CI, 0.3-2.7 days; P = .01) compared with NHFOV. Neonates who were treated with NCPAP needed reintubations more often than those who were treated with NIPPV (risk difference: 8.1%; 95% CI, 2.9%-13.3%; P = .003) and NHFOV (risk difference, 12.5%; 95% CI, 7.5%-17.4%; P < .001). There were fewer ventilator-free days in neonates treated with NCPAP than in those treated with NIPPV (median [25th-75th percentile] difference, −3 [−6 to −1] days; P = .01). There were no differences between secondary efficacy or safety outcomes, except for the use of postnatal corticosteroids (lower in NHFOV than in NCPAP group; risk difference, 7.3%; 95% CI, 2.6%-12%; P = .002), weekly weight gain (higher in NHFOV than in NCPAP group; mean difference, −0.9 g/d; 95% CI, −1.8 to 0 g/d; P = .04), and duration of study intervention (shorter in NHFOV than in NIPPV group; median [25th-75th percentile] difference, −1 [−3 to 0] days; P = .01).CONCLUSIONS AND RELEVANCE Results of this trial indicated that NHFOV, if used after extubation and until discharge, slightly reduced the duration of IMV in preterm neonates, and both NHFOV and NIPPV resulted in a lower risk of reintubation than NCPAP. All 3 respiratory support techniques were equally safe for this patient population.

<b><i>Objective:</i></b> To determine whether nasal high-frequency oscillatory ventilation (NHFOV) as a primary mode of respiratory support as compared with nasal continuous airway pressure (NCPAP) will reduce the need for invasive mechanical ventilation in preterm infants (26^0/7–33^6/7 weeks of gestational age [GA]) with respiratory distress syndrome (RDS). <b><i>Methods:</i></b> This multicenter randomized controlled trial was conducted in 18 tertiary neonatal intensive care units in China. A total of 302 preterm infants born at a GA of 26^0/7–33^6/7 weeks with a diagnosis of RDS were randomly assigned to either the NCPAP (<i>n</i> = 150) or the NHFOV (<i>n</i> = 152) group. The primary outcome was the need for invasive mechanical ventilation during the first 7 days after birth. <b><i>Results:</i></b> Treatment failure occurred in 15 of 152 infants (9.9%) in the ­NHFOV group and in 26 of 150 infants (17.3%) in the NCPAP group (95% CI of risk difference: −15.2 to 0.4, <i>p =</i> 0.06). In the subgroup analysis, NHFOV resulted in a significantly lower rate of treatment failure than did NCPAP in the strata of 26^+0/7–29^+6/7weeks of GA (11.9 vs. 32.4%, 95% CI of risk difference: −39.3 to −1.7, <i>p =</i> 0.03) and birth weight &#x3c;1,500 g (10.4 vs. 29.6%, 95% CI of risk difference: −33.8 to −4.6, <i>p =</i> 0.01). The rate of thick secretions causing an airway obstruction was higher in the NHFOV group than in the NCPAP group (13.8 vs. 5.3%, 95% CI of risk difference: 1.9–15.1, <i>p =</i> 0.01). No significant differences in other secondary outcomes were found between the NHFOV and NCPAP groups. <b><i>Conclusions:</i></b> NHFOV was not superior to NCPAP with regard to the primary outcome when applied as the primary respiratory support for RDS in infants between 26^+0/7 and 33^+6/7 weeks of GA. In the subgroup analysis, NHFOV seemed to improve effectiveness than NCPAP in preterm infants &#x3c;30 weeks of GA.

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Background: Patent ductus arteriosus (PDA) is a dramatically harmful disease in the neonatal period, in particular common in preterm infants, and our study was to determine related factors of PDA in preterm infants.Methods: A comprehensive literature review was conducted in PubMed, EMBASE, and Web of Science. The pooled odds ratio and standard mean difference were calculated to compare dichotomous and continuous variables, respectively. In addition, we also assessed the heterogeneity and publication bias and carried out sensitivity analysis for each related factor.Results: We included 45 studies with 87,419 individuals. After the primary analysis and a series of adjustments, results showed chorioamnionitis, lower gestational age, lower birth weight, bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, respiratory distress syndrome, sepsis, surfactant treatment, ventilation, and lower platelet count had a positive correlation with PDA, while small for gestational age decreased the incidence of PDA in preterm infants. Besides, premature rupture of membranes, preeclampsia, antenatal steroids, male gender, mean platelet volume, and platelet distribution width were found to have no statistically significant relationship with PDA.Conclusion: Preterm infants with more immature characteristics generally have a higher likelihood to develop PDA. The prevention, diagnosis, and management of PDA may depend on these results, and effective measures can be taken accordingly.

BackgroundInvasive mechanical ventilation (IMV) is associated with the development of adverse pulmonary and non-pulmonary outcomes in very premature infants. Various modes of non-invasive respiratory support are increasingly being used to decrease the incidence of bronchopulmonary dysplasia. The aim of this trial is to compare the effect of non-invasive high-frequency oscillatory ventilation (NHFOV) and nasal continuous positive airway pressure (NCPAP) in preterm infants with respiratory distress syndrome (RDS) as a primary non-invasive ventilation support mode.Methods/designIn this multi-center randomized controlled trial, 300 preterm infants born at a gestational age of 266/7 to 336/7 weeks with a diagnosis of RDS will be randomized to NHFOV or NCPAP as a primary mode of non-invasive respiratory support. The study will be conducted in 18 tertiary neonatal intensive care units in China.The primary outcome is the need for IMV during the first 7 days after enrollment in preterm infants randomized to the two groups. The prespecified secondary outcomes include days of hospitalization, days on non-invasive respiratory support, days on IMV, days on supplemental oxygen, mortality, need for a surfactant, severe retinopathy of prematurity requiring laser treatment or surgery, patent ductus arteriosus needing ligation, bronchopulmonary dysplasia, abdominal distention, air leak syndromes, intraventricular hemorrhage (≥ grade 3), spontaneous intestinal perforation, necrotizing enterocolitis (≥II stage), and nasal trauma. Other secondary outcomes include Bayley Scales of Infant Development at 18–24 months of corrected age.DiscussionIn recent decades, several observational studies have compared the effects of NHFOV and NCPAP in neonates as a rescue mode or during weaning from IMV. To our knowledge, this will be the first multi-center prospective, randomized controlled trial to evaluate NHFOV as a primary mode in preterm infants with RDS in China or any other part of the world. Our trial may help to establish guidelines for NHFOV in preterm infants with RDS to minimize the need for IMV, and to decrease the significant pulmonary and non-pulmonary morbidities associated with IMV.Trial registrationClinicalTrials.gov, NCT03099694. Registered on 4 April 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2673-9) contains supplementary material, which is available to authorized users.

Background: Coronavirus disease 2019 (COVID-19), sweeping across the world, has created a worldwide pandemic. Effective treatments of COVID-19 are extremely urgent.Objective: To analyze the efficacy and safety of convalescent plasma (CCP) on patients with COVID-19.Methods: All the relevant studies were searched from PubMed, EMBASE,Cochrane library, Scopus, Web of Science, CBM, CNKI, Wan fang, VIP, Medrxiv, Biorxiv, and SSRN on July 19, 2021. PICOS criteria were as follows: (P) the study interests were human subjects with the infection of COVID-19; (I) the intervention of interest was CCP; (C) comparator treatments contained placebo, sham therapy, and standard treatment; (O) the primary outcome was mortality rates by the novel coronavirus. The secondary outcomes included the incidence of serious adverse events, the rate of ICU admission and mechanical ventilation (MV); the length of hospital stay; the duration of MV and ICU stay; the antibody levels, inflammatory factor levels, and viral loads. (S) Only randomized controlled trials (RCTs) of CCP were included. Subanalysis, quality assessment, sensitive analysis, and publication bias were conducted by two reviewers independently.Results: Sixteen RCTs were included and enrolled a total of 16,296 participants in this meta-analysis. The pooled data showed that no significant difference was observed in reducing the rate of overall mortality between CCP treatment group and placebo group (OR 0.96; 95% CI 0.90 to 1.03; p = 0.30; I2 = 6%). According to the results of subgroup analysis, severe or critical patients with CCP showed significant difference in reducing the 28-day mortality of compared with placebo (OR 0.58, 95% CI 0.36 to 0.93, p = 0.02, I2 = 0%). CCP groups have a significantly shorter duration of MV compared with the control group (weighted MD −1.00, 95% CI −1.86 to −0.14 d p = 0.02, I2 = 0%). No significant difference was observed in the length of hospital stay, the duration of ICU, and the rate of ICU and MV. There is no conclusive evidence about the safety of CCP.Conclusion: Convalescent plasma can significantly reduce the 28-day mortality of severe or critical COVID-19 patients and the duration of MV. However, more evidence was needed to prove the safety of convalescent plasma.

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