Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants (NCT02743988) | Clinical Trial Compass
UnknownNot Applicable
Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants
Germany36 participantsStarted 2015-05
Plain-language summary
In this randomized crossover trial, preterm infants with intermittent hypoxemia and need for supplemental oxygen will be randomized to either Sequence of two different oxygen target ranges (low: 85-89%; high: 91-95%) for a total duration of 19 hours. Cerebral oxygenation, cardiac output, arterial oxygenation and heart rate will be measured continuously. Primary outcome is time with arterial oxygen saturation \< 80%.
Who can participate
Age range
21 Days – 42 Days
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:
* preterm infant \< 29 weeks gestation
* at least 8 hypoxemic events during 8 hours
* requires supplemental oxygen to achieve high SpO2 target range
* parental consent given
Exclusion Criteria:
* congenital life-threatening malformation
* fatal outcome expected
* airway malformation
* higher grade intraventricular bleeding (grade III or IV according to LA Papile)
* posthaemorrhagic hydrocephalus
* life-threatening disease at the time of study entry
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.
1This trial is testing different oxygen target ranges in preterm infants — can you explain what oxygen targeting means in practice, and how it differs from what my baby is already receiving in the NICU?
2The study is measuring how long a baby's oxygen level drops below 80%, which sounds very low — can you help me understand how serious those drops are and what risks might come with being in a study that adjusts oxygen targets?
3Since this trial's recruitment status is listed as unknown, can you find out whether it's still enrolling, and if not, whether there are other active studies looking at oxygen management for premature babies with intermittent hypoxemia?
4This trial is categorized as Phase NA, which typically means it's more of an observational or device/procedure study rather than a drug trial — can you explain what that means for what is and isn't known about the safety of the approach being tested?
5Are there standard NICU protocols for managing intermittent hypoxemia and apnea of prematurity that my baby's team is already following, and would participating in this trial change any of those standard care decisions?
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.