Determinants of Digestive Morbidity in Neonatal Jaundice (NCT07475624) | Clinical Trial Compass
CompletedNot Applicable
Determinants of Digestive Morbidity in Neonatal Jaundice
China3,218 participantsStarted 2019-12-01
Plain-language summary
Objective To explore the factors associated with adverse digestive system outcomes in neonates with jaundice.
Methods A retrospective analysis was conducted on clinical data of hospitalized neonates admitted to the Department of Neonatology, the First Hospital of Jilin University, within 7 days after birth from December 2019 to December 2024. Included neonates underwent serum total bilirubin testing, with post-birth serum total bilirubin levels exceeding the high-risk neonatal phototherapy threshold. Propensity score matching and inverse probability weighting were used to group the jaundiced neonates according to the presence or absence of adverse digestive system outcomes. Factors including basic demographic information of the neonates and their mothers, relevant laboratory examinations, and therapeutic interventions were collected. Traditional logistic regression and Cox proportional hazards models were applied to analyze and predict risk factors for adverse digestive system outcomes in jaundiced neonates.
Who can participate
Age range
1 Day – 28 Days
Sex
ALL
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Inclusion criteria
. Neonates admitted to the Department of Neonatology within 7 days after birth.
. Clinical diagnosis of neonatal jaundice, with a measured serum total bilirubin level exceeding the phototherapy threshold for hyperbilirubinemia.
. Availability of complete medical records and serum bilirubin test results.
. Hospitalized at the First Hospital of Jilin University between December 2019 and December 2024.
Exclusion criteria
. Major congenital anomalies (e.g., severe gastrointestinal malformations, complex congenital heart disease).
. Missing essential data for primary outcome or key exposure variables.
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.
What they're measuring
1
Adverse Digestive System Outcomes
Timeframe: From admission until hospital discharge or 28 days of life, whichever comes first.