A trial comparing continuous positive airway pressure (CPAP) devices in preterm infants.
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ABSTRACT: Objective
To test the hypothesis that infants born <30 weeks' gestation supported by Seattle-PAP will have lower rates of continuous positive airway pressure (CPAP) failure than infants supported with conventional, Fisher&Paykel-CPAP (FP-CPAP).Study design
Randomized trial (3/2017-01/2019) at 5 NICUs. The primary outcome was CPAP failure; subgroup analyses (gestational age, receipt antenatal corticosteroids) were performed.Results
A total of 232 infants were randomized. Infants in the Seattle-PAP and FP-CPAP groups had mean gestational ages of 27.0 and 27.2 weeks, respectively. We observed no differences in rates of treatment failure between Seattle-PAP (40/112, 35.7%) and FP-CPAP (38/120, 31.7%; risk difference, 4.1%; 95% CI, -8.1-16.2; P = 0.51). Subgroup analysis indicated no differences in rates of CPAP failure. We observed no differences between the two groups in frequencies of adverse events or duration of respiratory support.Conclusions
Among infants born <30 weeks' gestation, rates of CPAP failure did not differ between Seattle-PAP and FP-CPAP.
SUBMITTER: Backes CH
PROVIDER: S-EPMC7375950 | biostudies-literature | 2020 Aug
REPOSITORIES: biostudies-literature
Publications
A trial comparing continuous positive airway pressure (CPAP) devices in preterm infants.
Backes Carl H CH Cooper Jennifer N JN Notestine Jennifer L JL Alfred Crystal M CM Ball Molly K MK Rivera Brian K BK Lamp Jane M JM Marzec Laura L Stenger Michael R MR Moallem Mohannad M Miller Randy R RR Naik Apurwa A Beer Lindsey J LJ Howard Christopher R CR Welty Stephen E SE Peter Richardson C C Hillman Noah H NH Zupancic John A F JAF Stanberry Larissa I LI Hansen Thomas N TN Smith Charles V CV
Journal of perinatology : official journal of the California Perinatal Association 20200520 8
<h4>Objective</h4>To test the hypothesis that infants born <30 weeks' gestation supported by Seattle-PAP will have lower rates of continuous positive airway pressure (CPAP) failure than infants supported with conventional, Fisher&Paykel-CPAP (FP-CPAP).<h4>Study design</h4>Randomized trial (3/2017-01/2019) at 5 NICUs. The primary outcome was CPAP failure; subgroup analyses (gestational age, receipt antenatal corticosteroids) were performed.<h4>Results</h4>A total of 232 infants were randomized. I ...[more]
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Project description:Context and objectiveNoninvasive mechanical ventilation during the postoperative period (PO) following lung resection can restore residual functional capacity, improve oxygenation and spare the inspiratory muscles. The objective of this study was to assess the efficacy of continuous positive airway pressure (CPAP) associated with physiotherapy, compared with physiotherapy alone after lung resection.Design and settingOpen randomized clinical trial conducted in the clinical hospital of Universidade Estadual de Campinas.MethodSessions were held in the immediate postoperative period (POi) and on the first and second postoperative days (PO1 and PO2), and the patients were reassessed on the discharge day. CPAP was applied for two hours and the pressure adjustment was set between 7 and 8.5 cmH2O. The oxygenation index (OI), Borg scale, pain scale and presence of thoracic drains and air losses were evaluated.ResultsThere was a significant increase in the OI in the CPAP group in the POi compared to the Chest Physiotherapy (CP) group, P = 0.024. In the CP group the OI was significantly lower on PO1 (P = 0,042), than CPAP group. The air losses were significantly greater in the CPAP group in the POi and on PO1 (P = 0.001, P = 0.028), but there was no significant difference between the groups on PO2 and PO3. There was a statistically significant difference between the groups regarding the Borg scale in the POi (P < 0.001), but there were no statistically significant differences between the groups regarding the pain score.ConclusionCPAP after lung resection is safe and improves oxygenation, without increasing the air losses through the drains.Clinical trial registrationNCT01285648.
| S-EPMC10889452 | biostudies-literature
Project description:BackgroundContinuous positive airway pressure (CPAP) is widely used in preterm infants. Identification of readiness for weaning from CPAP can balance benefits with risks of CPAP exposure. We tested the hypothesis that preterm infants that successfully transition off CPAP have higher oxygen saturations prior to weaning compared with infants who fail weaning from CPAP.MethodsThis was a single-center-matched case-control study in infants ≤30 weeks' gestation receiving ≤30% FiO2 weaned off CPAP during the first postnatal week. Cases were infants placed back on CPAP within 7 days of being taken off CPAP, whereas control infants remained off CPAP for 7 consecutive days following CPAP discontinuation. Infants were matched on gestational age at birth (±10 days). Prospectively collected histograms detailing the distribution of oxygen saturations prior to CPAP discontinuation were compared between cases and controls.ResultsOver a 12-month monitoring period, 36 infants met inclusion criteria. Baseline characteristics, morbidities, and clinical variables did not differ between cases and controls. Controls achieved oxygen saturations of 95-97 and 97-100% for longer duration compared to cases (p < 0.05).ConclusionsIn preterm infants with RDS receiving CPAP and ≤30% FiO2, infants with higher oxygen saturations had greater success in transitioning off CPAP.
| S-EPMC7223394 | biostudies-literature
Project description:BackgroundNasal masks and nasal prongs are used as interfaces for providing continuous positive airway pressure (CPAP) for preterm infants with or at risk of respiratory distress, either as primary support after birth or as ongoing support after endotracheal extubation from mechanical ventilation. It is unclear which type of interface is associated with lower rates of CPAP treatment failure, nasal trauma, or mortality and other morbidity.ObjectivesTo assess the benefits and harms of nasal masks versus nasal prongs for reducing CPAP treatment failure, nasal trauma, or mortality and other morbidity in newborn preterm infants with or at risk of respiratory distress.Search methodsWe used standard, extensive Cochrane search methods. The latest search date was October 2021.Selection criteriaWe included randomised controlled trials comparing masks versus prongs as interfaces for delivery of nasal CPAP in newborn preterm infants (less than 37 weeks' gestation) with or at risk of respiratory distress.Data collection and analysisWe used standard Cochrane methods. Our primary outcomes were 1. treatment failure, 2. all-cause mortality, and 3. neurodevelopmental impairment. Our secondary outcomes were 4. pneumothorax, 5. moderate-severe nasal trauma, 6. bronchopulmonary dysplasia, 7. duration of CPAP use, 8. duration of oxygen supplementation, 9. duration of hospitalisation, 10. patent ductus arteriosus receiving medical or surgical treatment, 11. necrotising enterocolitis, 12. severe intraventricular haemorrhage, and 13. severe retinopathy of prematurity. We used the GRADE approach to assess the certainty of the evidence.Main resultsWe included 12 trials with 1604 infants. All trials were small (median number of participants 118). The trials occurred after 2001 in care facilities internationally, predominantly in India (eight trials). Most participants were preterm infants of 26 to 34 weeks' gestation who received nasal CPAP as the primary form of respiratory support after birth. The studied interfaces included commonly used commercially available masks and prongs. Lack of measures to blind caregivers or investigators was a potential source of performance and detection bias in all the trials. Meta-analyses suggested that use of masks compared with prongs may reduce CPAP treatment failure (risk ratio (RR) 0.72, 95% confidence interval (CI) 0.58 to 0.90; 8 trials, 919 infants; low certainty). The type of interface may not affect mortality prior to hospital discharge (RR 0.83, 95% CI 0.56 to 1.22; 7 trials, 814 infants; low certainty). There are no data on neurodevelopmental impairment. Meta-analyses suggest that the choice of interface may result in little or no difference in the risk of pneumothorax (RR 0.93, 95% CI 0.45 to 1.93; 5 trials, 625 infants; low certainty). Use of masks rather than prongs may reduce the risk of moderate-severe nasal injury (RR 0.55, 95% CI 0.44 to 0.71; 10 trials, 1058 infants; low certainty). The evidence is very uncertain about the effect on bronchopulmonary dysplasia (RR 0.69, 95% CI 0.46 to 1.03; 7 trials, 843 infants; very low certainty).Authors' conclusionsThe available trial data provide low-certainty evidence that use of masks compared with prongs as the nasal CPAP interface may reduce treatment failure and nasal injury, and may have little or no effect on mortality or the risk of pneumothorax in newborn preterm infants with or at risk of respiratory distress. The effect on bronchopulmonary dysplasia is very uncertain. Large, high-quality trials would be needed to provide evidence of sufficient validity and applicability to inform policy and practice.
| S-EPMC9662142 | biostudies-literature
Project description:ObjectiveThe objective of this exploratory study was to assess the potential impacts of two different continuous positive airway pressure (CPAP) devices on preterm infant head shape and circumference.Study designTwenty infants born at <32 weeks gestational age requiring CPAP support were enrolled. Ten infants used the Hudson RCI Nasal Prong CPAP device and 10 infants used the Fisher-Paykel CPAP device. Infant Cranial Index (CI) and head circumference (HC) were collected weekly as well as infant gestational age at birth, and total number of days on CPAP.ResultsAt baseline, average total birthweight of infants was 1021 grams (SD = 227 grams), average gestational age was 26.9 weeks (SD = 1.80), mean CI was 79.7 cm (SD = 5.95), and HC was 10.2 cm (SD = 0.92). Days on CPAP ranged from 16 to 63 days, with an average of 40.7 (SD = 13.6) days. Neither CI nor HC differed by device type; however, the Fisher-Paykel device was associated with slightly greater HC growth rate.ConclusionCPAP devices and the pressures they apply plausibly contribute to preterm infant cranial molding over time, with the greatest potential impact on infants who require CPAP support for longer periods; however, these findings must be validated in larger cohorts. Additionally, positioning practices should be further examined to determine how they may contribute to or prevent the development of cranial molding deformity.
| S-EPMC10569633 | biostudies-literature
Project description:To determine the early factors associated with continuous positive airway pressure (CPAP) failure in moderate-to-late preterm infants (32 + 0/7 to 36 + 6/7 weeks' gestation) from the NEOBS cohort study. The NEOBS study was a multi-center, prospective, observational study in 46 neonatal intensive care units in France, which included preterm and late preterm infants with early neonatal respiratory distress. This analysis included a subset of the NEOBS population who had respiratory distress and required ventilatory support with CPAP within the first 24 h of life. CPAP failure was defined as the need for tracheal intubation within 72 h of CPAP initiation. Maternal and neonatal clinical parameters in the delivery room and clinical data at 3 h of life were analyzed. CPAP failure occurred in 45/375 infants (12%), and compared with infants with CPAP success, they were mostly singletons (82.2% vs. 62.1%; p < 0.01), had a lower Apgar score at 10 min of life (9.1 ± 1.3 vs. 9.6 ± 0.8; p = 0.02), and required a higher fraction of inspired oxygen (FiO2; 34.4 ± 15.9% vs. 22.8 ± 4.1%; p < 0.0001) and a higher FiO2*positive end-expiratory pressure (PEEP) (1.8 ± 0.9 vs. 1.1 ± 0.3; p < 0.0001) at 3 h. FiO2 value of 0.23 (R2 = 0.73) and FiO2*PEEP of 1.50 (R2 = 0.75) best predicted CPAP failure. The risk of respiratory distress and early CPAP failure decreased 0.7 times per 1-week increase in gestational age and increased 1.7 times with every one-point decrease in Apgar score at 10 min and 19 times with FiO2*PEEP > 1.50 (vs. ≤ 1.50) at 3 h (R2 of the overall model = 0.83). Conclusion: In moderate-to-late preterm infants, the combination of singleton pregnancy, lower Apgar score at 10 min, and FiO2*PEEP > 1.50 at 3 h can predict early CPAP failure with increased accuracy. What is Known: •Respiratory distress syndrome (RSD) represents an unmet medical need in moderate-to-late preterm births and is commonly treated with continuous positive airway pressure (CPAP) to reduce mortality and the need for additional ventilatory support. • Optimal management of RSD is yet to be established, with several studies suggesting that identification of predictive factors for CPAP failure can aid in the prompt treatment of infants likely to experience this failure. What is New: •Secondary analysis of the observational NEOBS study indicated that oxygen requirements during CPAP therapy, especially the product of fraction of inspired oxygen (FiO2) and positive end-expiratory pressure (PEEP), are important factors associated with early CPAP failure in moderate-to-late term preterm infants. •The combination of a singleton pregnancy, low Apgar score at 10 minutes, and high FiO2*PEEP at 3 hours can predict early CPAP failure with increased accuracy, highlighting important areas for future research into the prevention of CPAP failure.
| S-EPMC10746609 | biostudies-literature
Project description:BackgroundExtremely preterm infants are often exposed to endotracheal tube continuous positive airway pressure (ETT-CPAP) trials to assess extubation readiness. The effects of ETT-CPAP trial on their diaphragmatic activity (Edi) and breathing variability is unknown.MethodsProspective observational study enrolling infants with birth weight ≤1250 g undergoing their first extubation attempt. Diaphragmatic activity, expressed as the absolute minimum (Edi min) and maximum values (Edi max), area under the Edi signal, and breath-by-breath analyses for breath areas, amplitudes, widths, and neural inspiratory and expiratory times, were analyzed during mechanical ventilation (MV) and ETT-CPAP. Neural breathing variability of each of these parameters was also calculated and compared between MV and ETT-CPAP.ResultsThirteen infants with median (interquartile range) birth weight of 800 g [610-920] and gestational age of 25.4 weeks [24.4-26.3] were included. Diaphragmatic activity significantly increased during ETT-CPAP when compared to MV:Edi max (44.2 vs. 38.1 μV), breath area (449 vs. 312 μV·s), and amplitude (10.12 vs. 7.46 μV). Neural breathing variability during ETT-CPAP was characterized by increased variability for amplitude and area under the breath, and decreased for breath time and width.ConclusionsA 5-min ETT-CPAP in extremely preterm infants undergoing extubation imposed significant respiratory load with changes in respiratory variability.ImpactETT-CPAP trials are often used to assess extubation readiness in extremely preterm infants, but its effects upon their respiratory system are not well known. Diaphragmatic activity analysis demonstrated that these infants are able to mount an important response to a short trial. A 5-min trial imposed a significant respiratory load evidenced by increased diaphragmatic activity and changes in breathing variability. Differences in breathing variability were observed between successful and failed extubations, which should be explored further in extubation readiness investigations. This type of trial cannot be recommended for preterm infants in clinical practice until clear standards and accuracy are established.
| S-EPMC7533985 | biostudies-literature
Project description: Not available
| S-EPMC8631577 | biostudies-literature
Project description:ObjectiveTo evaluate the effects of early treatment with continuous positive airway pressure (CPAP) on nutritional intake and in-hospital growth rates of extremely preterm (EPT) infants.Study designEPT infants (240/7-276/7 weeks of gestation) enrolled in the Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) were included. EPT infants who died before 36 weeks of postmenstrual age (PMA) were excluded. The growth rates from birth to 36 weeks of PMA and follow-up outcomes at 18-22 months corrected age of EPT infants randomized at birth to either early CPAP (intervention group) or early intubation for surfactant administration (control group) were analyzed.ResultsGrowth data were analyzed for 810 of 1316 infants enrolled in SUPPORT (414 in the intervention group, 396 in the control group). The median gestational age was 26 weeks, and the mean birth weight was 839 g. Baseline characteristics, total nutritional intake, and in-hospital comorbidities were not significantly different between the 2 groups. In a regression model, growth rates between birth and 36 weeks of PMA, as well as growth rates during multiple intervals from birth to day 7, days 7-14, days 14-21, days 21-28, day 28 to 32 weeks PMA, and 32-36 weeks PMA did not differ between treatment groups. Independent of treatment group, higher growth rates from day 21 to day 28 were associated with a lower risk of having a Bayley-III cognitive score <85 at 18-22 months corrected age (P = .002).ConclusionsEPT infants randomized to early CPAP did not have higher in-hospital growth rates than infants randomized to early intubation.
| S-EPMC8478787 | biostudies-literature
Project description:ObjectivesMicroorganisms are likely present in continuous positive airway pressure (CPAP) devices in daily use. Given the potential risk of infection among CPAP users, we aimed to compare the microbiomes of CPAP devices with those of nasal mucosa samples obtained from patients using these devices.MethodsWe conducted a prospective cohort study at multiple tertiary medical institutions. Samples were collected from the tubes and filters of CPAP devices and the nasal mucosa of device users. Microbiomes and mycobiomes were analyzed using 16S ribosomal RNA and internal transcribed spacer region sequencing. The results were compared according to sampling site and usage duration for each patient.ResultsOverall, 27 paired samples of human nasal mucosa and CPAP components were analyzed. Bacteria were detected in 7 of the 27 tubes (25.9%) and in 22 of the 27 filters (81.5%). Fungi were found in 2 tubes (7.4%) and 16 filters (59.3%). The most prevalent bacterial phyla across all samples were Actinobacteria and Firmicutes. Fungi were not detected in any nasal mucosa samples. However, fungi were identified in the CPAP filters and tubes, with the Basidiomycota and Ascomycota phyla predominating. No significant associations were identified according to sampling site or duration of CPAP use.ConclusionSome bacteria or fungi are detectable in CPAP samples, even after a short period of CPAP usage. However, the association between respiratory infections and these microbiomes or mycobiomes was not investigated. Further research is required to clarify the risk posed by CPAP devices as a microbial contamination source.
| S-EPMC11626094 | biostudies-literature
Project description:ObjectivesObstructive sleep apnea (OSA) is among the least studied risk factors for erectile dysfunction (ED). We aimed to determine ED prevalence in newly-diagnosed OSA patients, describe their main characteristics and assess continuous positive airway pressure (CPAP) effects on ED.MethodsCross-sectional study assessing ED prevalence in OSA patients and open-label, parallel, prospective randomized controlled trial evaluating 3-month CPAP treatment effects on sexual function, satisfaction, and psychological, hormonal and biochemical profiles. Male patients newly diagnosed with moderate/severe OSA (apnea-hypopnea index >20 events·h-1), aged 18-70 years, attending the sleep unit of a Spanish hospital during 2013-2016 were considered. A total of 150 patients were recruited (75 randomized ED patients). ED was defined as scores <25 on International Index Erectile Function 15 test. Wilcoxon's matched-pairs signed-ranks and rank-sum tests were used.ResultsED prevalence was 51%. Patients with ED were older (p<0.001), had greater waist-to-hip ratios (p<0.001), were more frequently undergoing pharmacological treatment (p<0.001) and had higher glucose levels (p = 0.024) than non-ED patients. Although significant increases in erectile function (mean(SD) change: +4.6(7.9); p = 0.002), overall satisfaction (+1(2.2); p = 0.035), and sexual satisfaction (+2.1(4.3); p = 0.003) were found after CPAP treatment, only differences in sexual satisfaction (p = 0.027) and erectile function (p = 0.060) were found between study arms. CPAP treatment did not impact psychological, hormonal or biochemical profiles.ConclusionsThis study confirmed the relationship between OSA and ED, suggesting the potential usefulness of ED screening in OSA patients, but could not determine conclusively whether CPAP is an effective stand-alone ED treatment, regardless of positive results on sexual satisfaction.Trial registrationClinicalTrials.gov NCT03086122.
| S-EPMC6082539 | biostudies-literature