QTc Intervals in Former Preterm/Extreme Low Birth Weight Infants: a Pooled Study Proposal (NCT05243537) | Clinical Trial Compass
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QTc Intervals in Former Preterm/Extreme Low Birth Weight Infants: a Pooled Study Proposal
Belgium, Canada250 participantsStarted 2023-01-01
Plain-language summary
Pooling effort to collect previously reported data on QTc time in former preterm neonates, and compare these data to controls. At present and based on a recently conducted systematic search, there are conflicting data on the potential QT interval prolongation (all Bazett) in former extreme low birth weight (ELBW, \<1000 g) infants or preterms.
Consequently, if investigators truly want to assess the presence or absence of either a difference or a prolongation of QTc intervals in this specific population, pooling of published data is likely the most effective approach (potential number of cases = 24 + 49 + 93 = 166; potential number of controls in the same studies = 24 + 53 + 87 = 164), preferably based on individual data.
Although the sample is to a large extent pragmatic (as available), the investigators hereby aim to target the 5 ms QTc prolongation applied by the authorities (FDA, EMA) in paired healthy adult volunteer studies as 'golden' standard as primary outcome variable \[EMA guideline, FDA guidance\].
Who can participate
Age range
8 Years – 25 Years
Sex
ALL
See this in plain English?
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Inclusion Criteria:
* included as 'case' in one of the cohorts retrieved by a systematic search on QTc values in former preterm neonates compared to healthy controls, or.
* included a 'control' in one of the cohorts retrieved by a systematic search on QTc values in former preterm neonates compared to healthy controls.
Exclusion Criteria:
* not included as 'case' in any of the cohorts retrieved by systematic search on QTc values in former preterm neonates compared to healthy controls
* not included as 'control' in any of the cohorts retrieved by systematic search on QTc values in former preterm neonates compared to healthy controls
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?
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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.