Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study. (NCT05806684) | Clinical Trial Compass
UnknownNot Applicable
Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
Italy1,586 participantsStarted 2023-05-01
Plain-language summary
The goal of this retrospective observational study is to \[learn about the correlation between hyperbilirubinemia and retinopathy of prematurity in preterm infants.
The main question it aims to answer are:
• To evaluate the possible effect of neonatal jaundice linked to the presumed protective antioxidant action of bilirubin on the development of ROP, compared to a control group which, although presenting ROP, did not develop jaundice.
Who can participate
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:
* Gestational age \< 32 weeks
* birth weight \< 1500g
Exclusion Criteria:
* lack of data regarding the development of ROP
* lack of data on the development of jaundice.
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
Number of subjects who developed Retinopathy of Prematurity (ROP) (divided by severity)
Timeframe: between 01/01/2010 and 12/31/2020
2
Number of subjects who developed jaundice
Timeframe: between 01/01/2010 and 12/31/2020
3
Duration of jaundice (days) for each subject
Timeframe: between 01/01/2010 and 12/31/2020
Trial details
NCT IDNCT05806684
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico