Amniotic Fluid & the Preterm Gut

NCT07152106 | Recruiting

• 1 other identifier: NL86579.018.24
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 2

Brief Summary

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.

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

Outcome Measures

Primary Outcomes (1)

• AF & preterm birth

  Microbial \& metabolic composition of amniotic fluid in extremely preterm birth

  Baseline

Secondary Outcomes (3)

• AF profiles & chorioamnionitis

  Baseline

• AF & fetal growth restriction

  Baseline

• AF & neonatal gut microbiota

  For AF baseline measurement, for neonatal gut microbiota composition at t=0, t=7, t=14, t=21, and t=28 (postnatal days)

Study Arms (1)

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

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Infants included in the study group must be born between 24+0/7 and 27+6/7 weeks. AF samples are also collected from a reference group, including early midtrimester (GA ≤23+6/7 weeks), very and moderate to late preterm (GA 28+0/7-36+6/7 weeks), and full-term pregnancies (GA 37+0/7-41+6/7 weeks).

You may qualify if:

• Maternal age ≥16 years
• Written informed consent
• Successful collection of amniotic fluid

You may not qualify if:

• Pregnancies complicated by fetal congenital and/or chromosomal abnormalities.
• Insufficient proficiency of Dutch or English language

Sponsors & Collaborators

• Maxima Medical Center: lead

Study Sites (2)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Máxima Medical Center

Veldhoven, Netherlands

RECRUITING

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Amniotic fluid

MeSH Terms

Conditions

Chorioamnionitis; Neonatal Sepsis; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Membranes, Premature Rupture; Obstetric Labor Complications; Placenta Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sepsis; Infections; Infant, Newborn, Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Growth Disorders

Central Study Contacts

Mirjam M. van Weissenbruch

CONTACT

020 566 9111; m.vanweissenbruch@amsterdamumc.nl

Hendrik Niemarkt, dr

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 3, 2025
• Study Start: October 14, 2024
• Primary Completion (Estimated): October 14, 2026
• Study Completion (Estimated): October 14, 2027
• Last Updated: September 3, 2025

Record last verified: 2025-07

Locations

NL (2)