Dataset Information

Sudden versus gradual pressure wean from Nasal CPAP in preterm infants: a randomized controlled trial.

ABSTRACT: 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.

SUBMITTER: Amatya S

PROVIDER: S-EPMC5446290 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Sudden versus gradual pressure wean from Nasal CPAP in preterm infants: a randomized controlled trial.

Amatya S S Macomber M M Bhutada A A Rastogi D D Rastogi S S

Journal of perinatology : official journal of the California Perinatal Association 20170223 6

<h4>Objective</h4>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.<h4>Study design</h4>A randomized controlled t ...[more]

PMID: 28230835

Similar Datasets

Project description:ImportanceNasal continuous positive airway pressure (nCPAP) is a well-established treatment of respiratory distress syndrome in preterm infants. Suboptimal weaning from nCPAP may be associated with lung injury, pulmonary morbidity, and infant weight gain. To our knowledge, the best weaning strategy from nCPAP is unknown.ObjectiveTo compare the effect of sudden wean and pressure wean from nCPAP in very preterm infants.Design, setting, and participantsA randomized, clinical, open-label, multicenter trial was conducted at 6 neonatal intensive care units in Denmark from September 2012 to December 2016 and included infants born before 32 weeks of gestation.InterventionsSudden wean with discontinuation of nCPAP without a prior reduction in pressure. Pressure wean with gradual pressure reduction prior to the discontinuation of nCPAP.Main outcome and measuresThe primary outcome was weight gain velocity from randomization to postmenstrual age 40 weeks. Secondary outcomes included other measures of growth, nCPAP and the duration of oxygen supplementation, postmenstrual age at successful wean and at discharge, successful wean at the first attempt, the number of attempts to wean, and the length of the hospital stay. Prespecified subgroup analyses by gestational age were performed.ResultsOf the 372 randomized infants, 185 (49.7%) were randomized to sudden wean and 187 infants (50.3%) to pressure wean. A total of 177 infants in both groups completed the trial (median gestational age for sudden and pressure wean, 30 weeks [interquartile range, 29-31]; male: sudden wean, 89 [50%]; pressure wean, 96 [54%]). There was no difference in mean [SD] weight gain velocity from randomization to 40 weeks postmenstrual age between the 2 groups (22 [6] g/kg/day). No difference was found in any of the secondary outcomes. More infants born before 28 weeks of gestation were successfully weaned from nCPAP during the first attempt in the pressure wean group compared with the sudden wean group (risk difference, 31%; 95% CI, 13%-50%), but there was no difference in the duration of nCPAP and oxygen supplementation.Conclusions and relevanceOverall, we found no difference in weight gain velocity or any of the secondary outcomes between very preterm infants who were randomized to sudden wean or pressure wean from nCPAP. However, among infants born before 28 weeks' gestation, infants from the pressure wean group were more often successfully weaned during the first attempt without a longer total duration of nCPAP treatment.Trial registrationClinicalTrials.gov Identifier: NCT01721629.

Project description:BACKGROUND:There are limited data to inform the choice between early treatment with continuous positive airway pressure (CPAP) and early surfactant treatment as the initial support for extremely-low-birth-weight infants. METHODS:We performed a randomized, multicenter trial, with a 2-by-2 factorial design, involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. Infants were randomly assigned to intubation and surfactant treatment (within 1 hour after birth) or to CPAP treatment initiated in the delivery room, with subsequent use of a protocol-driven limited ventilation strategy. Infants were also randomly assigned to one of two target ranges of oxygen saturation. The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks (with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30% oxygen). RESULTS:A total of 1316 infants were enrolled in the study. The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group (47.8% and 51.0%, respectively; relative risk with CPAP, 0.95; 95% confidence interval [CI], 0.85 to 1.05) after adjustment for gestational age, center, and familial clustering. The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks (rates of primary outcome, 48.7% and 54.1%, respectively; relative risk with CPAP, 0.91; 95% CI, 0.83 to 1.01). Infants who received CPAP treatment, as compared with infants who received surfactant treatment, less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia (P<0.001), required fewer days of mechanical ventilation (P=0.03), and were more likely to be alive and free from the need for mechanical ventilation by day 7 (P=0.01). The rates of other adverse neonatal outcomes did not differ significantly between the two groups. CONCLUSIONS:The results of this study support consideration of CPAP as an alternative to intubation and surfactant in preterm infants. (ClinicalTrials.gov number, NCT00233324.)

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.

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: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.

Dataset Information

Sudden versus gradual pressure wean from Nasal CPAP in preterm infants: a randomized controlled trial.

Publications

Sudden versus gradual pressure wean from Nasal CPAP in preterm infants: a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets