Study Results
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Basic Information
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RECRUITING
275 participants
OBSERVATIONAL
2024-10-14
2027-10-14
Brief Summary
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Necrotizing enterocolitis (NEC) and sepsis in preterm infants have been linked to intestinal immaturity and preclinical gut microbiota alterations. An important yet understudied contributor in the development of the gastrointestinal tract (GIT) is amniotic fluid (AF). Knowledge is lacking on the critical shifts that may occur in AF in extremely preterm birth. The aim of the current study is to assess the composition of AF using advanced biomedical techniques. Secondary objectives are to assess AF profiles of infants with chorioamnionitis (CAM) and/or fetal growth restriction (FGR), assess key metabolites across gestation, correlate AF profiles with neonatal outcomes, and explore associations with early gut microbiota.
Methods:
ln this multicenter, prospective, cohort study, AF (\~5 mL) will be collected from obstetric patients delivering their infants extremely preterm (gestational age (GA) 24+0/7-27+6/7 weeks, n=125), either during vaginal delivery or cesarean section (CS). Additionally, AF samples will be collected from a reference group (n=150), including early midtrimester (GA \<23+/7 weeks), very early and moderate to late preterm (GA 28+0/6-36+6/7 weeks), and full-term pregnancies (GA 37+0/7-41+6/7 weeks). Thorough characterization of AF will be conducted, including microbial profiling and metabolomics. Microbiota profiling of neonatal fecal samples will be conducted to assess the association between AF and early neonatal gut colonization patterns.
Discussion and expected results:
AF profiles associated with CAM and/or FGR in extremely preterm infants are expected to be identified, as well as relevant associations with neonatal health outcomes (including NEC and sepsis) and early neonatal gut colonization patterns. The current study will not only increase the understanding of the GIT development and the pathogenesis of NEC and sepsis but may also aid in the identification of high-risk infants. In the future, these findings may facilitate early targeted microbiota-based interventions to prevent disease progression and ultimately improve clinical outcomes.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort
Total cohort consists of: 1) study group - gestational age 24+0/7-27+6/7 weeks, 2) reference/control group: \<24+0/7 weeks and 28+0/7-40+6/7 weeks
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
* Successful collection of amniotic fluid
Exclusion Criteria
* Insufficient proficiency of Dutch or English language
16 Years
FEMALE
Yes
Sponsors
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Maxima Medical Center
OTHER
Responsible Party
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Hendrik Niemarkt
Principal Investigator
Locations
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Amsterdam UMC
Amsterdam, , Netherlands
Máxima Medical Center
Veldhoven, , Netherlands
Countries
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Central Contacts
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Hendrik Niemarkt, dr
Role: CONTACT
Facility Contacts
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References
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Puri K, Taft DH, Ambalavanan N, Schibler KR, Morrow AL, Kallapur SG. Association of Chorioamnionitis with Aberrant Neonatal Gut Colonization and Adverse Clinical Outcomes. PLoS One. 2016 Sep 22;11(9):e0162734. doi: 10.1371/journal.pone.0162734. eCollection 2016.
de Kroon RR, de Baat T, Senger S, van Weissenbruch MM. Amniotic Fluid: A Perspective on Promising Advances in the Prevention and Treatment of Necrotizing Enterocolitis. Front Pediatr. 2022 Mar 14;10:859805. doi: 10.3389/fped.2022.859805. eCollection 2022.
Dasgupta S, Arya S, Choudhary S, Jain SK. Amniotic fluid: Source of trophic factors for the developing intestine. World J Gastrointest Pathophysiol. 2016 Feb 15;7(1):38-47. doi: 10.4291/wjgp.v7.i1.38.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NL86579.018.24
Identifier Type: OTHER
Identifier Source: secondary_id
NL86579.018.24
Identifier Type: -
Identifier Source: org_study_id
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