The Impact of Amniotic Fluid on the Development and Microbial Colonization of the Preterm Intestinal Tract: the AMFIBIE Study
| Registry | NCT07152106, acronym AMFIBIE |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 275 (Estimated) |
| Sponsor | Maxima Medical Center (Other) |
| Conditions | Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn, Necrotizing Enterocolitis of Newborn, Neonatal Sepsis, Early-Onset, Neonatal Sepsis, Late-Onset, Fetal Growth Restriction (FGR), Preterm Birth Complication, Prematurity Complications |
| Dates | start 2024-10-14, primary completion 2026-10-14 (estimated), completion 2027-10-14 (estimated), first posted 2025-09-03, last updated 2025-09-03 |
| Locations | 2 sites in Netherlands |
Related Papers Related Patents Related Grants Related Experts
All trials for Chorioamnionitis All trials for Chorioamnionitis Affecting Fetus or Newborn
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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 |
Sex: Female, ages: 16 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Amsterdam UMC | Amsterdam | Netherlands | Recruiting |
| Máxima Medical Center | Veldhoven | Netherlands | Recruiting |