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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adverse Digestive Outcome | Neonates with jaundice who developed adverse digestive system outcomes. |
| |
| Non-Adverse Digestive Outcome | Neonates with jaundice who did not develop adverse digestive system outcomes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation (Retrospective Cohort Study) | Other | This is an observational study. The "intervention" described here refers to the standard diagnostic and therapeutic measures already administered in routine clinical practice for neonatal jaundice. The study retrospectively observes the association between these routine practices (e.g., phototherapy, exchange transfusion, intravenous immunoglobulin administration) and the infants' digestive system outcomes. The research protocol did not actively assign or modify any treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Digestive System Outcomes | The presence of any clinically diagnosed adverse digestive outcome during hospitalization, including but not limited to feeding intolerance, necrotizing enterocolitis (NEC), cholestasis, or gastrointestinal bleeding. | From admission until hospital discharge or 28 days of life, whichever comes first. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population is a retrospective cohort of neonates hospitalized in the Department of Neonatology at the First Hospital of Jilin University between December 2019 and December 2024. All included neonates were admitted within the first 7 days of life and were diagnosed with neonatal hyperbilirubinemia, defined as having a serum total bilirubin level exceeding the phototherapy threshold for their respective postnatal age and gestational age. This cohort will be analyzed to investigate the risk factors associated with the development of adverse digestive system outcomes.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Jilin City | Changchun | 130021 | China |
The individual participant data are derived from retrospective medical records. Data sharing is restricted by the hospital's data governance policies and Chinese regulations on personal information protection.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2025 | Feb 28, 2026 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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