Amniotic fluid and the extremely preterm baby's gut
The Impact of Amniotic Fluid on the Development and Microbial Colonization of the Preterm Intestinal Tract: the AMFIBIE Study
Maxima Medical Center · NCT07152106
We will see if amniotic fluid from extremely preterm births (24+0 to 27+6 weeks) shows changes that relate to gut problems such as necrotizing enterocolitis or sepsis in very preterm infants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 275 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | Maxima Medical Center (other) |
| Locations | 2 sites (Amsterdam and 1 other locations) |
| Trial ID | NCT07152106 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective cohort will collect about 5 mL of amniotic fluid from 125 deliveries at gestational ages 24+0 to 27+6 weeks at Amsterdam UMC and Máxima Medical Center. Samples will be obtained during vaginal delivery or cesarean section and analyzed using advanced molecular, metabolomic, and microbiome techniques to characterize fluid composition. Secondary analyses will compare amniotic fluid profiles in cases with maternal chorioamnionitis or fetal growth restriction, examine key metabolites across gestation, and correlate amniotic fluid signatures with neonatal outcomes and early gut microbiota. No interventions are given; the project is observational and aims to identify biomarkers and biological signals linked to NEC and neonatal sepsis risk.
Who should consider this trial
Good fit: Ideal candidates are obstetric patients aged 16 or older who deliver extremely preterm infants (gestational age 24+0 to 27+6 weeks) at the participating centers and can provide written informed consent.
Not a fit: Patients delivering outside the specified gestational age range, pregnancies with fetal congenital or chromosomal abnormalities, those unable to provide consent, or those delivering at non-participating hospitals are not expected to benefit from this project.
Why it matters
Potential benefit: If successful, the findings could identify amniotic fluid biomarkers that help predict which extremely preterm infants are at higher risk of NEC or sepsis, enabling earlier monitoring or tailored care.
How similar studies have performed: Previous research has linked amniotic fluid components to fetal gut development, but comprehensive molecular profiling in the extremely preterm population is relatively novel and not yet well established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam and 1 other locations
- Amsterdam UMC — Amsterdam, Netherlands (RECRUITING)
- Máxima Medical Center — Veldhoven, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Mirjam M. van Weissenbruch
- Email: m.vanweissenbruch@amsterdamumc.nl
- Phone: 020 566 9111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn, Necrotizing Enterocolitis of Newborn, Neonatal Sepsis, Early-Onset, Neonatal Sepsis, Late-Onset, Fetal Growth Restriction, Preterm Birth Complication, Prematurity Complications