Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Phase
Observational
Started
2014-07-20
Last updated
2024-04-17
Condition(s) studied
Preterm InfantGut Microbiome
Study summary
The aim of this study is to obtain a longitudinal view of the gut microbial establishment of a cohort of 51 preterm (PT) infants compared to 50 full-term (FT) infants from birth to 90 days of age, and to identify key clinical factors that affect the establishment of neonatal microbiome.
The hypothesis of the investigators is that the gut microbiota progression of PT group and FT group is different in diversity and composition. Antibiotics and its usage duration is likely the main factor disturbing the colonization and development of the gut microbiome of PT infants.
Eligibility
Sex
ALL
Min age
1 Day
Max age
4 Months
Healthy volunteers
Accepted
Inclusion Criteria:
Preterm infants
1. gestational age \<37 weeks;
2. no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis;
3. hospital stay \> 7 days;
Exclusion criteria:
1. NICU stay less than 7 days
2. Necrotizing enterocolitis infant
Control group:
1. Full-term healthy infants;
2. gestational age \>37 weeks;
3. vaginally born;
4. no gastrointestinal tract disorders, metabolic diseases, or viral hepatitis.
Primary outcome measure(s)
changes in gut microbiota over time and in relation to antibiotic treatment — 0-7 years after birth Fecal DNA at different time points to measure the gut microbiota of preterm infants and full-term infants to investigate the development of early microbial colonization and the impact of antibiotics on the early life of preterm infants
Trial sites (1)
Facility
City
Region
Status
Department of NICU, XinHua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
China
Recruiting
More Xinhua Hospital, Shanghai Jiao Tong University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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