BACKGROUND: In spite of widespread use of nasal CPAP there are comparatively few studies to guide the choice of nasal prongs. OBJECTIVES: To determine whether the Fisher & Paykel Healthcare (FPH) neonatal continuous positive airway pressure (CPAP) interface was effective in providing bubble CPAP when compared to the Hudson prong interface. METHODS:The study was a randomized cross-over study of twenty newborn infants 500 g or more requiring CPAP for respiratory support at birth. Infants were randomized to either the Fisher & Paykel Healthcare or Hudson CPAP interface for twenty four hours. Crossover between interfaces occurred after subsequent twenty four hour periods. The primary outcome was the provision of desired CPAP pressures, defined as provision of CPAP within ± one cm H 2 O of set pressure. RESULTS: The percentage time CPAP was within ± one cm H 2 O of set pressure was 66.5% for the Hudson and 71.8% for the FPH interface (p = 0.66). Oxygen saturations for the Hudson interface were in target range for a median of 97.8% of the time, and, with the FPH interface, for a median of 98.2% of the time (p = 0.76). Clinically significant differences in primary or secondary outcomes between the two groups were not detected. CONCLUSIONS: The nasal CPAP interfaces studied were equally effective in achieving desired bubble CPAP pressures and target saturations.
Background It is the investigator’s responsibility to communicate the relevant information about a clinical trial to participants before they provide informed consent to take part. Systematic reviews indicate that participants often have a poor understanding of the concepts which are key to ensuring valid informed consent, such as randomisation and risks/discomforts. Paper-based participant information leaflets and informed consent forms (PIL/ICFs) are becoming longer and are often too complex for many participants. Multimedia interventions and enhanced PIL/ICFs have been trialled in an attempt to improve participants’ understanding of various aspects of research studies. However, there is insufficient empirical evidence to determine how effective such interventions are. This protocol describes a study to evaluate whether an enhanced PIL/ICF and website help research participants to understand important information about a human immunodeficiency virus (HIV) randomised clinical trial. Methods This Study Within A Trial (SWAT) is a prospective, multi-centre, randomised, controlled, parallel-group study embedded in a host clinical trial. The host trial (the SWIFT trial; EudraCT: 2019-002314-39) is a prospective, multi-centre, randomised, open-label, controlled trial investigating if semaglutide along with dietary advice assists individuals with HIV and obesity to lose weight, compared to dietary advice alone. For the SWAT, participants will be randomised in a 1:1 ratio to either the control (standard PIL/ICF) or the intervention (an enhanced PIL/ICF and a website which includes animations). The enhanced PIL/ICF and website were developed in line with the guidance from organisations which promote plain English and accessible public-facing materials in conjunction with HIV Ireland, a HIV advocacy organisation, and our previous work on consent documents. The primary outcome of the SWAT is the quality of informed consent, assessed by a validated comprehension test—the modified Deaconess Informed Consent Comprehension Test (DICCT). The DICCT will be administered within 48 h of consent to the host trial. The secondary is recall, measured by the modified DICCT questionnaire scores 2 weeks post-consent to the host trial. Discussion The results of this SWAT will add to the methodological evidence base on the use of multimedia to improve the quality of informed consent to randomised clinical trials. Trial registration ClinicalTrials.govNCT04174755. EudraCT 2019-002314-39. SWAT 160, Northern Ireland Hub for Trials Methodology Research SWAT repository (Clarke M, et al., Trials. 16:P209, 2015).
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