Hazards to avoid in future neonatal studies of nasal high-frequency oscillatory ventilation: lessons from an early terminated trial
Abstract Objective To investigate whether nasal high-frequency oscillatory ventilation (nHFOV) started immediately after extubation of mechanically ventilated very low birth weight infants reduces the partial pressure of carbon dioxide at 72 h after extubation in comparison with nasal continuous pos...
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| Format: | Article |
| Language: | English |
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BMC
2019-04-01
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| Series: | BMC Research Notes |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13104-019-4268-2 |
| _version_ | 1819046705600921600 |
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| author | Hendrik S. Fischer Christoph Bührer Christoph Czernik |
| author_facet | Hendrik S. Fischer Christoph Bührer Christoph Czernik |
| author_sort | Hendrik S. Fischer |
| collection | DOAJ |
| description | Abstract Objective To investigate whether nasal high-frequency oscillatory ventilation (nHFOV) started immediately after extubation of mechanically ventilated very low birth weight infants reduces the partial pressure of carbon dioxide at 72 h after extubation in comparison with nasal continuous positive airway pressure. This randomised controlled single-centre trial aimed to include 68 preterm infants at high risk of extubation failure. Results Implementation of the study protocol was feasible. However, from 2015 to 2017, only six patients could be recruited, leading to early termination of the trial. The slow recruitment was due to the introduction of new strategies to avoid endotracheal mechanical ventilation, which reduced the number of eligible infants. Moreover, the included infants failed their extubation more often than anticipated, thereby increasing the required sample size. Based on our single-centre experience, we provide information for study planning and discuss the specific requirements for future trial protocols on nHFOV. The extubation of high-risk infants into nHFOV could well be beneficial, but a multicentric approach is necessary to investigate this hypothesis. Trial Registration Clinicaltrials.gov NCT02340299, on 16 January 2015 |
| first_indexed | 2024-12-21T10:48:43Z |
| format | Article |
| id | doaj.art-db41efcbfda24f35b9c3f0ce881f39bb |
| institution | Directory Open Access Journal |
| issn | 1756-0500 |
| language | English |
| last_indexed | 2024-12-21T10:48:43Z |
| publishDate | 2019-04-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Research Notes |
| spelling | doaj.art-db41efcbfda24f35b9c3f0ce881f39bb2022-12-21T19:06:44ZengBMCBMC Research Notes1756-05002019-04-011211610.1186/s13104-019-4268-2Hazards to avoid in future neonatal studies of nasal high-frequency oscillatory ventilation: lessons from an early terminated trialHendrik S. Fischer0Christoph Bührer1Christoph Czernik2Department of Neonatology, Charité – Universitätsmedizin BerlinDepartment of Neonatology, Charité – Universitätsmedizin BerlinDepartment of Neonatology, Charité – Universitätsmedizin BerlinAbstract Objective To investigate whether nasal high-frequency oscillatory ventilation (nHFOV) started immediately after extubation of mechanically ventilated very low birth weight infants reduces the partial pressure of carbon dioxide at 72 h after extubation in comparison with nasal continuous positive airway pressure. This randomised controlled single-centre trial aimed to include 68 preterm infants at high risk of extubation failure. Results Implementation of the study protocol was feasible. However, from 2015 to 2017, only six patients could be recruited, leading to early termination of the trial. The slow recruitment was due to the introduction of new strategies to avoid endotracheal mechanical ventilation, which reduced the number of eligible infants. Moreover, the included infants failed their extubation more often than anticipated, thereby increasing the required sample size. Based on our single-centre experience, we provide information for study planning and discuss the specific requirements for future trial protocols on nHFOV. The extubation of high-risk infants into nHFOV could well be beneficial, but a multicentric approach is necessary to investigate this hypothesis. Trial Registration Clinicaltrials.gov NCT02340299, on 16 January 2015http://link.springer.com/article/10.1186/s13104-019-4268-2ExtubationHigh-frequency ventilationHypercapniaNasal continuous positive airway pressurePremature infantRandomised controlled trial |
| spellingShingle | Hendrik S. Fischer Christoph Bührer Christoph Czernik Hazards to avoid in future neonatal studies of nasal high-frequency oscillatory ventilation: lessons from an early terminated trial BMC Research Notes Extubation High-frequency ventilation Hypercapnia Nasal continuous positive airway pressure Premature infant Randomised controlled trial |
| title | Hazards to avoid in future neonatal studies of nasal high-frequency oscillatory ventilation: lessons from an early terminated trial |
| title_full | Hazards to avoid in future neonatal studies of nasal high-frequency oscillatory ventilation: lessons from an early terminated trial |
| title_fullStr | Hazards to avoid in future neonatal studies of nasal high-frequency oscillatory ventilation: lessons from an early terminated trial |
| title_full_unstemmed | Hazards to avoid in future neonatal studies of nasal high-frequency oscillatory ventilation: lessons from an early terminated trial |
| title_short | Hazards to avoid in future neonatal studies of nasal high-frequency oscillatory ventilation: lessons from an early terminated trial |
| title_sort | hazards to avoid in future neonatal studies of nasal high frequency oscillatory ventilation lessons from an early terminated trial |
| topic | Extubation High-frequency ventilation Hypercapnia Nasal continuous positive airway pressure Premature infant Randomised controlled trial |
| url | http://link.springer.com/article/10.1186/s13104-019-4268-2 |
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