CompletedNot Applicable

Pulse Oximetry Measurement and Transfusions

United States75 participantsStarted 2014-04

Plain-language summary

The primary purpose of this observational study was to determine if pRBC transfusions decrease the frequency of intermittent hypoxia events in very low birth weight infants (VLBW) during the first six weeks of life. The impact on non-pRBC transfusions on the frequency of intermittent hypoxia was also assessed.

Who can participate

Age range

6 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: * 23+0 to 28+6 weeks gestational age at birth Exclusion Criteria: * Infants with life-limiting diagnoses * Cyanotic heart disease * In utero fetal transfusion * Twin to twin transfusion syndrome * Isoimmune hemolytic disease * Severe acute hemorrhage * Acute shock * Sepsis with coagulopathy * Need for perioperative transfusion * Parents opposed to transfusion of blood * Parents with hemoglobinopathy or congenital anemia

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

Change in number of Intermittent hypoxia

Timeframe: Change in number of intermittent hypoxia before (approximately 8 hours) and after transfusion (approximately 8 hours).

Trial details

NCT IDNCT04249193

SponsorChristiana Care Health Services

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-10

View on ClinicalTrials.gov More Hypoxia Neonatal trials