Association of Chorioamnionitis with Aberrant Neonatal Gut Colonization and Adverse Clinical Outcomes.
Kriti Puri, Diana H Taft, Namasivayam Ambalavanan...
https://pubmed.ncbi.nlm.nih.gov/27658190Actively Recruiting
Led by Maxima Medical Center · Updated on 2025-09-03
275
Participants Needed
2
Research Sites
52 weeks
Total Duration
Researchers are studying the role of amniotic fluid in the development and microbial colonization of the intestinal tract in extremely preterm infants born between 24 and 27 weeks of gestation. The study aims to understand how changes in amniotic fluid composition relate to conditions like chorioamnionitis and fetal growth restriction, and how these changes might affect neonatal outcomes such as necrotizing enterocolitis and sepsis. This observational study involves detailed profiling of amniotic fluid and early gut microbiota to identify patterns linked to these risks. The study collects about 5 mL of amniotic fluid from mothers delivering extremely preterm infants either vaginally or via cesarean section. It also includes a reference group of pregnancies at various gestational ages, from early midtrimester to full term. The collected fluid is analyzed using advanced biomedical techniques for microbial and metabolic profiles. Neonatal fecal samples will also be studied at days 0, 7, 14, 21, and 28 to examine early gut colonization. Participants will be involved through the collection of amniotic fluid at birth and neonatal stool samples over the first month of life. Researchers will monitor and analyze amniotic fluid characteristics in relation to chorioamnionitis, fetal growth restriction, and neonatal health outcomes including necrotizing enterocolitis and sepsis. The study aims to improve understanding of gastrointestinal development in preterm infants and identify high-risk cases, potentially guiding future interventions. The total study duration spans from birth through the first 28 postnatal days for microbiota monitoring.
CONDITIONS
Amniotic Fluid & the Preterm Gut
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At birth and postnatal days 0 to 28
Participants undergo collection of amniotic fluid and initial neonatal gut microbiota sampling to understand baseline profiles.
5 visits (in-person) on days 0, 7, 14, 21, and 28
Duration - Up to 28 days postnatal
Participants are monitored for the development and microbial colonization of the preterm intestinal tract over the first month after birth.
Included in Diagnostic Evaluation visits
Total: 2 locations
1
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
2
Máxima Medical Center
Veldhoven, Netherlands
Actively Recruiting
M
Mirjam M. van Weissenbruch
H
Hendrik Niemarkt, dr
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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