An observational study in Respiratory Insufficiency in Children, sponsored by Vyaire Medical. Completed at 5 sites in 2 countries. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by Vyaire Medical · Observational
This study is planned as a part of the post market clinical follow-up (PMCF) on a CE marked product. The purpose of the study is to demonstrate, in a routine clinical environment across a number of centers, that the fabian-PRICO can adequately maintain oxygen saturation, with minimal staff intervention.
This is a randomized cross-over study. Subjects will be assigned to two, nominally 24-hour interventions, one with standard manual titration of FiO2 and the other with automated adjustment (PRICO). The order of these two interventions will be random.
In addition to the ventilators data, basic demographics (i.e., gestational age, birth weight, age, weight at study) of the participating infants will be recorded in the eCRF.
This study has no additional follow-up visits.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's enrollment of 47 is below the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Vyaire Medical is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Members of the Investigational team will periodically review records to identify and maintain a pool of potential investigation candidates from the NICU. It is anticipated that this pool will be significantly larger than capacity of the team to enroll into the investigation.
The parents of potential candidates will be approached for discussion and consent prior to the desired intervention.
Exclusion Criteria:
24 hours of automated control of FiO2
24 hours of manual control of FiO2
Target Range Compliance:
Percent-Time with SpO2 a) \<80% and b) with \>98% SpO2 with FiO2\>21%
Time frame: 24 hours
Avoidance of SpO2 Extremes:
Percent-Time with SpO2 a) \<80% and b) with \>98% SpO2 with FiO2\>21%
Time frame: 24 hours
Plan to share: No
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Vyaire Medical