Actively Recruiting

Age: 16Years +
FEMALE
Healthy Volunteers
ID07152106

The Impact of Amniotic Fluid on the Development and Microbial Colonization of the Preterm Intestinal Tract: the AMFIBIE Study

Led by Maxima Medical Center · Updated on 2025-09-03

275

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Amniotic Fluid & the Preterm Gut

Who Can Participate

Age: 16Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Maternal age 60 16 years
  • Written informed consent
  • Successful collection of amniotic fluid
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

Trial Site Locations

Total: 2 locations

1

Amsterdam UMC

Amsterdam, Netherlands

Actively Recruiting

2

Máxima Medical Center

Veldhoven, Netherlands

Actively Recruiting

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Research Team

M

Mirjam M. van Weissenbruch

H

Hendrik Niemarkt, dr

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Amniotic Fluid: A Perspective on Promising Advances in the Prevention and Treatment of Necrotizing Enterocolitis.

Rimke Romee de Kroon, Tessa de Baat, Stefania Senger...

https://pubmed.ncbi.nlm.nih.gov/35359891

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.

Rimke R de Kroon, Sofie van Weelden, Loes Monen...

https://pubmed.ncbi.nlm.nih.gov/41602874