An observational study in NEC - Necrotizing Enterocolitis, sponsored by The First Hospital of Jilin University. Active, not recruiting at 1 site in China. Open to participants aged 24 Weeks to 36 Weeks. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by The First Hospital of Jilin University · Observational
This prospective cohort study aims to investigate the impact of early antibiotic exposure on the establishment of gut microbiota and motility in newborns, particularly preterm infants. The study will explore the correlation between antibiotic exposure, gut microbiota colonization, and 5-hydroxytryptamine (5-HT) levels, which are critical for gastrointestinal motility. The findings may provide insights into optimizing antibiotic use and improving gastrointestinal health in neonates.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's planned enrollment of 200 is above the median of 144 across 95 observational studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →The First Hospital of Jilin University is the lead sponsor of 185 studies on the registry; 96 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study will enroll newborns admitted to the neonatal unit of Jilin University First Hospital from November 2024 to November 2027.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Description: Newborns with gestational age 24-36 weeks who receive antibiotics within the first 72 hours of life.
gut microbiota
Impact of antibiotic exposure on gut microbiota colonization assessed by 16S rRNA sequencing.
Time frame: Enrollment Period: This is the time during which participants will be recruited and enrolled into the study. You have specified that enrollment will occur from November 2024 to November 2027. Intervention Period: Since this is an observational study, the
Plan to share: No
Started Feb 2025 (actual). Primary completion is estimated for May 2027, 27 months after the start.
Of 39 observational studies under Enterocolitis, Necrotizing, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 115. This study's planned 27 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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The First Hospital of Jilin University →