Amniotic Fluid & the Preterm Gut
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn, Necrotizing Enterocolitis of Newborn, Neonatal Sepsis, Early-Onset. Basic parameters: from 16 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of Amniotic Fluid on the Development and Microbial Colonization of the Preterm Intestinal Tract: the AMFIBIE Study
Overview
Background: 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.
Primary outcome measures
- AF & preterm birth [Time frame: Baseline]
Secondary outcome measures (3)
- AF profiles & chorioamnionitis [Time frame: Baseline]
- AF & fetal growth restriction [Time frame: Baseline]
- AF & neonatal gut microbiota [Time frame: For AF baseline measurement, for neonatal gut microbiota composition at t=0, t=7, t=14, t=21, and t=28 (postnatal days)]
Eligibility criteria
Inclusion criteria
- Maternal age ≥16 years
- Written informed consent
- Successful collection of amniotic fluid
Exclusion criteria
- Pregnancies complicated by fetal congenital and/or chromosomal abnormalities.
- Insufficient proficiency of Dutch or English language
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Netherlands · 2 centers
- Amsterdam UMC — Amsterdam
- Máxima Medical Center — Veldhoven
Publications
- 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. PMID 27658190
- 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. PMID 35359891
- 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. PMID 26909227
- de Kroon RR, van Weelden S, Monen L, Bakker P, Pajkrt E, Struys EA, Budding AE, de Meij T, Niemarkt HJ, van Weissenbruch MM. The impact of AMniotic FluId on the development and microBIal colonization of the prEterm intestinal tract (AMFIBIE): study protocol for a multicenter prospective cohort study. Front Pediatr. 2026 Jan 12;13:1721519. doi: 10.3389/fped.2025.1721519. eCollection 2025. PMID 41602874
Identifiers
NCT: NCT07152106 · NL86579.018.24 · NL86579.018.24