ChorioamnionitisAMFIBIENCT07152106
Amniotic Fluid & the Preterm Gut
An observational study of Chorioamnionitis and Chorioamnionitis Affecting Fetus or Newborn, run by Maxima Medical Center at 2 sites in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn, Necrotizing Enterocolitis of Newborn
- How many people
- 275 participants
- Where
- 2 sitesNetherlands
- Study dates
- 14 Oct 2024to 14 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- Maternal age ≥16 years
- Written informed consent
- Successful collection of amniotic fluid
Who cannot join
- Pregnancies complicated by fetal congenital and/or chromosomal abnormalities.
- Insufficient proficiency of Dutch or English language
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hendrik Niemarkt, dr contact
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Mirjam M. van Weissenbruch, 020 566 9111, m.vanweissenbruch@amsterdamumc.nl
- Recruiting
Máxima Medical Center
Veldhoven
Hendrik Niemarkt, 040 888 8000, hendrik.niemarkt@mmc.nl
About this study
Official title: The Impact of Amniotic Fluid on the Development and Microbial Colonization of the Preterm Intestinal Tract: the AMFIBIE Study
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.
Read more
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)
- Medical subject headings
- Chorioamnionitis, Neonatal Sepsis, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF & preterm birth
Microbial \& metabolic composition of amniotic fluid in extremely preterm birth
Measured: Baseline
Secondary outcomes (3)
AF profiles & chorioamnionitis
Characterizion of AF profiles in infants exposed to chorioamnionitis
Measured: Baseline
AF & fetal growth restriction
Characterizion of AF profiles in infants with fetal growth restriction
Measured: Baseline
AF & neonatal gut microbiota
To correlate composition of amniotic fluid to neonatal gut microbiota in first month of life
Measured: For AF baseline measurement, for neonatal gut microbiota composition at t=0, t=7, t=14, t=21, and t=28 (postnatal days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start14 Oct 2024
- Primary completion14 Oct 2026 (estimated)
- Study completion14 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ChorioamnionitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxima Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hendrik Niemarkt, Maxima Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152106
- Sponsor's protocol ID
- NL86579.018.24
- Other IDs
- NL86579.018.24
- Acronym
- AMFIBIE
- Status last verified
- Jul 2025
- First submitted
- 20 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 27658190de 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.
PubMed 35359891Dasgupta 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.
PubMed 26909227de 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.
PubMed 41602874
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Amniotic Fluid on the Development and Microbial Colonization of the Preterm Intestinal Tract: the AMFIBIE Study
- ClinicalTrials.gov ID
- NCT07152106
- Acronym / sponsor ID
- AMFIBIE / NL86579.018.24
- Conditions
- Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn, Necrotizing Enterocolitis of Newborn, Neonatal Sepsis, Early-Onset, Neonatal Sepsis, Late-Onset, Fetal Growth Restriction (FGR)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 14 Oct 2026 (estimated)
- Study completion
- 14 Oct 2027 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- Maternal age ≥16 years
- Written informed consent
- Successful collection of amniotic fluid
Key exclusion criteria (2 listed)
- Pregnancies complicated by fetal congenital and/or chromosomal abnormalities.
- Insufficient proficiency of Dutch or English language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AF & preterm birth
Time frame: Baseline
Microbial \& metabolic composition of amniotic fluid in extremely preterm birth
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Results publication: PubMed 27658190Puri 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.
- Results publication: PubMed 35359891de 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.
- Results publication: PubMed 26909227Dasgupta 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.
- Derived from this study: PubMed 41602874de 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hendrik Niemarkt, dr contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chorioamnionitis and Chorioamnionitis Affecting Fetus or Newborn, run by Maxima Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mirjam M. van Weissenbruch (020 566 9111, m.vanweissenbruch@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF & preterm birth (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07152106, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.