DigestiveNCT07475624
Determinants of Digestive Morbidity in Neonatal Jaundice
An observational study of Digestive, run by The First Hospital of Jilin University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Digestive
- What is being tested?
- Observation (Retrospective Cohort Study)
- Type of treatment
- Injection or infusion
- How many people
- 3,218 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Major congenital anomalies (e.g., severe gastrointestinal malformations, complex congenital heart disease).
- Missing essential data for primary outcome or key exposure variables.
- Length of hospital stay < 24 hours.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Jilin University
Jilin City, Changchun, 130021
About this study
Official title: Analysis of Factors Associated With Adverse Digestive System Outcomes in Neonates With Jaundice
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.
- Conditions
- Digestive
- Being tested
- Observation (Retrospective Cohort Study)
- Keywords
- neonates with jaundice ,adverse digestive outcomes,association
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Adverse Digestive Outcome | Neonates with jaundice who developed adverse digestive system outcomes. Receives: Other: Observation (Retrospective Cohort Study) | |
| Non-Adverse Digestive Outcome | Neonates with jaundice who did not develop adverse digestive system outcomes. Receives: Other: Observation (Retrospective Cohort Study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From admission until hospital discharge or 28 days of life, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Dec 2019
- Primary completion1 Dec 2024
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DigestiveStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,218 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475624
- Sponsor's protocol ID
- 2025-MS-074
- Status last verified
- Jan 2026
- First submitted
- 23 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Factors Associated With Adverse Digestive System Outcomes in Neonates With Jaundice
- ClinicalTrials.gov ID
- NCT07475624
- Acronym / sponsor ID
- 2025-MS-074
- Conditions
- Digestive
- Keywords
- neonates with jaundice ,adverse digestive outcomes,association
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,218 participants (actual)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adverse Digestive Outcome | – | Other: Observation (Retrospective Cohort Study)Neonates with jaundice who developed adverse digestive system outcomes. |
| Non-Adverse Digestive Outcome | – | Other: Observation (Retrospective Cohort Study)Neonates with jaundice who did not develop adverse digestive system outcomes. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Major congenital anomalies (e.g., severe gastrointestinal malformations, complex congenital heart disease).
- Missing essential data for primary outcome or key exposure variables.
- Length of hospital stay < 24 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation (Retrospective Cohort Study)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. | Other | Adverse Digestive Outcome, Non-Adverse Digestive Outcome |
Primary outcome
Adverse Digestive System Outcomes
Time frame: From admission until hospital discharge or 28 days of life, whichever comes first.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digestive, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Digestive System Outcomes (time frame: From admission until hospital discharge or 28 days of life, whichever comes first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.