Trial reportPloS one2019
'Nasal mask' in comparison with 'nasal prongs' or 'rotation of nasal mask with nasal prongs' reduce the incidence of nasal injury in preterm neonates supported on nasal continuous positive airway pressure (nCPAP): A randomized controlled trial.
Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05513508 (A Pragmatic Open Label, Multi-center, Spontaneous, No-profit, Randomized Controlled Clinical Trial With Non-significant Risk Medical Device on the Rotational Use of Interfaces Versus Standard of Care for Patients Treated With NPPV for AHRF.), which is not on this map. Cited by 28 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Pragmatic Open Label, Multi-center, Spontaneous, No-profit, Randomized Controlled Clinical Trial With Non-significant Risk Medical Device on the Rotational Use of Interfaces Versus Standard of Care for Patients Treated With NPPV for AHRF.
Who cites it
28 citing papers in PubMed, 4 syntheses or guidelines pooled it, 73 citations in OpenAlex.
- Prevention of nasal injury in preterm infants during positive pressure ventilation: a systematic review of interface and dressing selection.BMC pediatrics · 2025Pooled it
- Mask-related pressure injury prevention associated with non-invasive ventilation: A systematic review.International wound journal · 2024Pooled it
- European Consensus Guidelines on the Management of Respiratory Distress Syndrome: 2022 Update.Neonatology · 2023Guideline
- Masks versus prongs as interfaces for nasal continuous positive airway pressure in preterm infants.The Cochrane database of systematic reviews · 2022Pooled it
- Non-invasive high-frequency oscillatory ventilation versus non-invasive intermittent mandatory ventilation as a rescue mode in preterm infants with respiratory distress on nasal CPAP-a randomized control trial.European journal of pediatrics · 2025Trial
- Trial
- RAM cannula with Cannulaide versus Hudson prongs for delivery of nasal continuous positive airway pressure in preterm infants: an RCT.Scientific reports · 2021Trial
- Interface leakage during neonatal CPAP treatment: a randomised, cross-over trial.Archives of disease in childhood. Fetal and neonatal edition · 2021Trial
- Cannula With Long and Narrow Tubing vs Short Binasal Prongs for Noninvasive Ventilation in Preterm Infants: Noninferiority Randomized Clinical Trial.JAMA pediatrics · 2021Trial
- OcclusiveEuropean respiratory review : an official journal of the European Respiratory Society · 2026Review
- Incidence and Risk Factors of Nasal Pressure Injuries in Neonates Receiving Noninvasive Ventilation.Journal of clinical medicine · 2026Article
- Seeing beyond the obvious: pragmatic skin care guidance for infants 22-24 weeks gestational age.Journal of perinatology : official journal of the California Perinatal Association · 2025Review
- Nasal Injuries Related to Respiratory Support Interfaces in Preterm Infants: Neonatal Course and 12-Month Outcome.Children (Basel, Switzerland) · 2025Article
- Nasal Trauma Among Neonatal Intensive Care Unit Patients: A Retrospective Single Center Experience.Pediatric health, medicine and therapeutics · 2025Article
- The Impasse On Nasal Interfaces For Non-Invasive Ventilation: Time To Move On?Indian journal of pediatrics · 2024Article
- Safety of bubble nasal intermittent positive pressure ventilation (NIPPV) versus bubble nasal continuous positive airway pressure (NCPAP) in preterm infants with respiratory distress.Journal of perinatology : official journal of the California Perinatal Association · 2024Article
- Summary of the best evidence for the prevention of nasal injury in preterm infants with nasal noninvasive ventilation.Translational pediatrics · 2024Article
- Heated and humidified high flow therapy (HHHFT) in extreme and very preterm neonates with respiratory distress syndrome (RDS): a retrospective cohort from a tertiary care setting in Pakistan.BMJ paediatrics open · 2024Article
- Complications associated with incorrect use of nasal CPAP.Journal of perinatology : official journal of the California Perinatal Association · 2023Review
- Incidence of nasal pressure injury in preterm infants on nasal mask noninvasive ventilation.Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo · 2023Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWith increasing use of nCPAP, the safety and comfort associated with nCPAP have come into the forefront. The reported incidence of nasal injuries associated with the use of nCPAP is 20% to 60%. A recent meta-analysis concluded that the use of nasal masks significantly decreases CPAP failure and the incidence of moderate to severe nasal injury and stress the need for a well powered RCT to confirm their findings.
methodsIn this Open label, 3 arms, sequential, stratified randomized controlled trial, we evaluated the incidence and severity of nasal injury at removal of nCPAP when using two different nasal interfaces and in three groups (i.e. rotation group, mask continue group, prong continue group). Preterm infants with gestation ≤ 30 weeks and respiratory distress within the first 6 hours of birth and in need of CPAP were eligible for the study.
resultsAmong the 175 newborns included in the study, incidence of nasal injury in mask continue group [n = 19/57 (33.3%)] was significantly less as compared to prong continue group [n = 55/60 (91.6%)] and rotation group [33/ 58 (56.9%), p value <0.0001]. Median maximum nasal injury score was significantly less in Mask continue group as compared to Prong continue group and Rotation group [Injury Score 0 (IQR 0-1) vs. Injury Score 3 (IQR 2-5) vs. Injury Score 1 (IQR 0-2), p value = <0.0001] respectively. The proportion of infants failing nCPAP was similar across the three groups.
conclusionnCPAP with nasal masks significantly reduces nasal injury in comparison with nasal prongs or rotation of nasal prongs and nasal masks. However, the type of interface did not affect the nCPAP failure rates.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.