Effects of Automated Adjustment of Inspired Oxygen With Combined Adaptive Mechanical Backup Venti… (NCT02774408) | Clinical Trial Compass
UnknownNot Applicable
Effects of Automated Adjustment of Inspired Oxygen With Combined Adaptive Mechanical Backup Ventilation as Compared to Automated Oxygen Adjustment Alone in Preterm Infants With Intermittent Hypoxemic Events During Non-invasive Ventilatory Support
37 participantsStarted 2016-06
Plain-language summary
In this 2-phase cross-over study the investigators test the hypothesis that automated adjustment of the inspired oxygen with the combined use of synchronized noninvasive SpO2-sensitive and apnea-sensitive backup-ventilation (S-NIPPV) increases the time within the intended oxygen saturation range as compared to automated FiO2 adjustment alone.
Who can participate
Age range
96 Hours – 34 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. postmenstrual age \<34 wks GA at study time (\<32 wks GA at birth)
. on nasal/nasopharyngeal CPAP or nasal IMV / IPPV
. at least 4 desaturations (SpO2 \<80%) during an 8 hour period within the 24h before the study using a standard pulse oximeter incorporated in the NICU (Masimo SET, Irvine, CA, averaging time 8 sec; delay 10s)
. informed consent obtained from the parents or legal guardian
Exclusion criteria
. postnatal age \<96h (to exclude rapidly changing conditions during the early phase of RDS and to avoid handling of the infant during the critical period for IVH)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary outcome measure is the total duration of time with an arterial oxygen saturation as measured by pulse oxymetry (percentage of the total recording time) within the target range (88-95%).
. Average FiO2 during the last 24h bevor the active study phase \>0.60 (too sick for non-invasive ventilator support)
. Congenital malformations of the lung or the diaphragm (i.e. diaphragmatic hernia, congenital cystic lung diseases...)
. Clinical evidence for seizures
. Ongoing Sepsis with hemodynamic compromise (defined as a CrP \> 20mg/l or positive blood culture (for sepsis), and requirement of catecholamines (for hemodynamic compromise))