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Nasal HFOV versus nasal IPPV as a post-extubation respiratory support in preterm infants-a randomised controlled trial.

ABSTRACT: Early and successful extubation prevents several morbidities in preterm newborns. Several secondary non-invasive respiratory modalities exist but with their merits and demerits. Given the benefits of nasal high-frequency oscillatory ventilation (nHFOV), we tried to examine whether nHFOV could reduce reintubation rates compared to nasal intermittent positive pressure ventilation (NIPPV) during the post-extubation phase in preterm infants. Stratified randomisation based on gestational age was done for 86 mechanically ventilated preterm infants between 26 and 36⁺⁶ weeks of gestation within 2 weeks of age to receive either nHFOV or NIPPV post-extubation. The main objective was to compare extubation failure within 72 h following extubation and secondarily feed intolerance, intraventricular haemorrhage (IVH) (> grade 3), composite bronchopulmonary dysplasia (BPD)/mortality, composite duration of oxygen supplementation/ventilation support and SpO2/FiO2 ratio. No statistical difference was noted for primary outcome (RR 0.8, 95% CI: 0.23 to 2.78; p = 1.00) and secondary outcomes. However, nHFOV appeared possibly better in respect to feed tolerance rates and pCO2 washout.Conclusion: Extubation failure within 72 h in infants less than 37 weeks of gestation did not differ between the two groups. However, nHFOV seems promising in reducing enteral feeding issues and pCO2 elimination. Larger multicentre studies are required for exploring benefits of nHFOV.Trial registration: www.ctri.nic.in id CTRI/2019/07/020055, registration date July 5, 2019 What is Known: • NIPPV is superior to nCPAP as a secondary mode of respiratory support. • Synchronisation is preferred for optimum ventilation. What is New: • nHFOV, a novel non-invasive respiratory modality without need for synchronisation, appears promising as a secondary mode subject to further trials. • It seems promising in reducing enteral feeding issues and pCO2 elimination.

SUBMITTER: Seth S

PROVIDER: S-EPMC8062142 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Respiratory support is crucial for the survival of preterm infants, and High-flow Nasal Cannula Oxygen Therapy (HFNC) and Continuous Positive Airway Pressure (CPAP) are commonly used for neonatal respiratory support. This meta-analysis aimed to compare the effects of HFNC and CPAP in primary respiratory support for preterm infants, to provide evidence-based support for clinical practice. PubMed, Embase, Cochrane Library, ClinicalTrials.gov, CNKI, VIP, WANFANG and SinoMed were searched for eligible studies. The primary outcomes included the incidence of treatment failure and the application of mechanical ventilation. A total of 27 eligible studies with 3,351 participants were included. There was no significant difference in the incidence of respiratory support failure [RR = 1.17, 95%CI (0.88-1.56)] and the application of mechanical ventilation [RR = 1.00, 95%CI (0.84-1.19)] between HFNC group and CPAP group. HFNC resulted in lower rate of air leaks [RR = 0.65, 95%CI (0.46-0.92)], nasal trauma [RR = 0.36, 95%CI (0.29-0.45)] and abdominal distension [RR = 0.39, 95%CI (0.27-0.58)], and later time of mechanical ventilation initiating [SMD = 0.60, 95%CI (0.21-0.99)], less duration of oxygen therapy [SMD = -0.35, 95%CI (-0.68 to -0.02)] and earlier enteral feeding [SMD = -0.54, 95%CI (-0.95 to -0.13)]. Alternative non-invasive respiratory support after initial treatment failure resulted in no difference in the application of mechanical ventilation between the two groups [RR = 0.99, 95%CI (0.52-1.88)]. HFNC might be more effective and safer in primary respiratory support for preterm infants. Using CPAP as a remedy for the treatment failure of HFNC could not avoid intubation. For premature infants with the gestational age <28 weeks, HFNC as primary respiratory support still needs to be further elucidated. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022313479, identifier: CRD42022313479.

Project description:IntroductionRespiratory distress syndrome is a complication of prematurity and extremely preterm infants born before 28 weeks' gestation often require endotracheal intubation and mechanical ventilation. In this high-risk population, mechanical ventilation is associated with lung injury and contributes to bronchopulmonary dysplasia. Therefore, clinicians attempt to extubate infants as quickly and use non-invasive respiratory support such as nasal continuous positive airway pressure (CPAP) to facilitate the transition. However, approximately 60% of extremely preterm infants experience 'extubation failure' and require reintubation. While CPAP pressures of 5-8 cm H2O are commonly used, the optimal CPAP pressure is unknown, and higher pressures may be beneficial in avoiding extubation failure. Our trial is the Extubation CPAP Level Assessment Trial (ÉCLAT). The aim of this trial is to compare higher CPAP pressures 9-11 cm H2O with a current standard pressures of 6-8 cmH2O on extubation failure in extremely preterm infants.Methods and analysis200 extremely preterm infants will be recruited prior to their first extubation from mechanical ventilation to CPAP. This is a parallel group randomised controlled trial. Infants will be randomised to one of two set CPAP pressures: CPAP 10 cmH2O (intervention) or CPAP 7 cmH2O (control). The primary outcome will be extubation failure (reintubation) within 7 days. Statistical analysis will follow standard methods for randomised trials on an intention to treat basis. For the primary outcome, this will be by intention to treat, adjusted for the prerandomisation strata (GA and centre). We will use the appropriate parametric and non-parametric statistical tests.Ethics and disseminationEthics approval has been granted by the Monash Health Human Research Ethics Committees. Amendments to the trial protocol will be submitted for approval. The findings of this study will be written into a clinical trial report manuscript and disseminated via peer-reviewed journals (on-line or in press) and presented at national and international conferences.Trial registration numberACTRN12618001638224; pre-results.

Project description:OBJECTIVE:In preterm infants, nasal continuous positive airway pressure (NCPAP) is widely used for treatment of respiratory distress syndrome. However, the strategies for successfully weaning infants off NCPAP are still not well defined and there remains considerable variation between the methods. The objective of this study is to determine whether gradual weaning of NCPAP pressure is more successful than sudden weaning off NCPAP to room air. STUDY DESIGN:A randomized controlled trial was conducted in a level 3 neonatal intensive care unit on 70 preterm neonates who were born between 26 and 32 weeks gestation and required NCPAP for at least 48?h. When infants were stable on NCPAP at 0.21 FiO2 and 5?cm H2O positive end expiratory pressure, neonates were randomized to the gradual wean group (reduction in pressure by 1?cm every 8?h until 3?cm H20 was reached) or to sudden wean group (one time NCPAP removal to room air). The primary outcome was a success at the first trial to wean to room air. Secondary outcomes were a number of trials, and weight and postmenstrual age (PMA) at the time of successful wean. Total number of days on NCPAP and length of stay (LOS) in the hospital were also compared between the groups. RESULTS:Of the 70 infants included in the study, 35 were randomized to sudden group and 33 infants to gradual group (2 excluded for protocol deviation). In sudden and gradual groups, 14 and 22 infants, respectively, were weaned successfully in the first attempt (P=0.03). The infants were successfully weaned at 32.7±1.7 weeks versus 33.1±2.4 weeks (P=0.39) PMA and at a weight of 1651±290?g versus 1589±398?g (P=0.46) in the sudden and gradual groups, respectively. The total number of days on NCPAP was 27±19 days versus 32±24 days (P=0.38) and LOS was 63±25 days versus 63±22 days (P=0.99) in the sudden and gradual groups, respectively. CONCLUSIONS:Gradual weaning method was more successful as compared to sudden weaning method in the initial trial off NCPAP. There was no difference in the PMA, weight at the time of successful wean, total days on NCPAP and LOS between the two groups.

Project description:To compare whether alternate rotation of nasal mask with nasal prongs every 8 h as compared to continuous use of either interface alone decreases the incidence of nasal injury in preterm infants receiving nasal Continuous Positive Airway Pressure (nCPAP). This was an open-label, three-arm, stratified randomized controlled trial where infants < 35 weeks receiving nCPAP were randomized into three groups using two different nasal interfaces (continuous prongs group, continuous mask group, and rotation group). All infants were assessed for nasal injury six hours post-removal of nCPAP using grading suggested by Fischer et al. The nursing care was uniform across all three groups. Intention-to-treat analysis was done. Fifty-seven infants were enrolled, with nineteen in each group. The incidence of nasal injury was 42.1% vs. 47.4% vs. 68.4% in the rotation group, continuous mask, and continuous prongs groups, respectively (P = 0.228). On adjusted analysis (gestational age, birth weight, and duration of nCPAP therapy), the incidence of nasal injury was significantly less in the rotation group as compared to continuous prongs group (Adjusted Odds Ratio [AOR], 95% confidence interval [CI]; 0.10 [0.01-0.69], P = 0.02) and a trend towards lesser nasal injury as compared to continuous mask group (AOR, 95% CI; 0.15 [0.02-1.08], P = 0.06). However, there was no significant difference in incidence of nasal injuries between continuous prongs versus continuous mask group (P = 0.60). The need for surfactant, nCPAP failure rate, duration of nCPAP, and common neonatal co-morbidities were similar across all three groups. Conclusion: Systematic rotation of nasal mask with nasal prongs significantly reduced nasal injury among preterm infants on nCPAP as compared to continuous use of nasal prongs alone without affecting nCPAP failure rate. Trial registration: CTRI/2019/01/017320, registered on 31/01/2019. What is Known: • Use of nasal mask as an interface for nasal Continuous Positive Airway Pressure decreases nasal injury as compared to nasal prongs. What is New: • Rotation of nasal prongs and nasal mask interfaces alternately every 8 h may reduce the nasal injury even further as compared to either interface alone.

Project description:BackgroundPlacental transfusion (by means of delayed cord clamping (DCC), cord milking, or cord stripping) confers benefits for preterm infants. It is not known if providing respiratory support to preterm infants before cord clamping improves outcomes.ObjectivesTo assess the efficacy and safety of respiratory support provided during DCC compared with no respiratory support during placental transfusion (in the form of DCC, milking, or stripping) in preterm infants immediately after delivery.Search methodsWe used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL, 2017, Issue 5), MEDLINE via PubMed (1966 to 19 June 2017), Embase (1980 to 19 June 2017), and CINAHL (1982 to 19 June 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials.Selection criteriaRandomized, cluster randomized, or quasi-randomized controlled trials enrolling preterm infants undergoing DCC, where one of the groups received respiratory support before cord clamping and the control group received no respiratory support before cord clamping.Data collection and analysisAll review authors assisted with data collection, assessment, and extraction. Two review authors assessed the quality of evidence using the GRADE approach. We contacted study authors to request missing information.Main resultsOne study fulfilled the review criteria. In this study, 150 preterm infants of less than 32 weeks' gestation undergoing 60 second DCC were randomized to a group who received respiratory support in the form of continuous positive airway pressure (CPAP) or positive pressure ventilation during DCC and a group that did not receive respiratory support during the procedure. Mortality during hospital admission was not significantly different between groups with wide confidence intervals (CI) for magnitude of effect (risk ratio (RR) 1.67, 95% CI 0.41 to 6.73). The study did not report neurodevelopmental disability and death or disability at two to three years of age. There were no significant differences between groups in condition at birth (Apgar scores or intubation in the delivery room), use of inotropic agents (RR 1.25, CI 0.63 to 2.49), and receipt of blood transfusion (RR 1.03, 95% CI 0.70 to 1.54). In addition, there were no significant differences in the incidences of any intraventricular haemorrhage (RR 1.50, 95% CI 0.65 to 3.46) and severe intraventricular haemorrhage (RR 1.33, 95% CI 0.31 to 5.75). Several continuous variables were reported in subgroups depending on method of delivery. Unpublished data for each group as a whole was made available and showed peak haematocrit in the first 24 hours and duration of phototherapy did not differ significantly. Overall, the quality of evidence for several key neonatal outcomes (e.g. mortality and intraventricular haemorrhage) was low because of lack of precision with wide CIs.Authors' conclusionsThe results from one study with wide CIs for magnitude of effect do not provide evidence either for or against the use of respiratory support before clamping the umbilical cord. A greater body of evidence is required as many of the outcomes of interest to the review occurred infrequently. Similarly, the one included study cannot answer the question of whether the intervention is or is not harmful.

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Nasal HFOV versus nasal IPPV as a post-extubation respiratory support in preterm infants-a randomised controlled trial.

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