The impact of amniotic fluid on the development and microbial colonization of the preterm intestinal tract: the AMFIBIE study

The impact of amniotic fluid on the development and microbial colonization of the preterm intestinal tract: the AMFIBIE study - Amniotic fluid and preterm gut health: the AMFIBIE study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56939

Enrollment

275

Registered

2024-08-06

Start date

2024-10-25

Completion date

Unknown

Last updated

2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity preterm birth

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Amniotic fluid will be collected from the study population consisting of obstetric patients delivering their infants extremely preterm (pregnancy duration between 24 + 0 - 27 + 6/7 weeks) (n = 125) and from a reference cohort (respectively, early midtrimester ( 16 years of age and mentally competent, amniotic fluid can be collected at time of extremely preterm delivery between 24 and 27 + 6/7 weeks of gestation and informed consent is obtained from the obstetric patient, the participant can be included in the study. Inclusion criteria reference cohort: If the obstetric patient is > 16 years of age and mentally competent and amniotic fluid can be collected during clinically indicated amniocentesis (during early midtrimester pregnancies) or at time of delivery, by means of vaginal delivery or cesarean section, in very to moderate and late preterm pregnancies or full term pregnancies, the participant can be included in the study.

Exclusion criteria

Exclusion criteria: Exclusion criteria study population: Obstetric patients

Design outcomes

Primary

Measure	Time frame
The main outcome is the characterization of the bacterial and metabolic composition of AF derived from obstetric patients delivering their infants extremely preterm using advanced biomedical techniques.	—

Secondary

Measure	Time frame
The secondary outcome measures are: 1. Analysis of amniotic fluid profiles of extremely preterm infants exposed to inflammation in utero versus extremely preterm infants not exposed to inflammation in utero. 2. Analysis of amniotic fluid profiles of extremely preterm infants with fetal growth restriction versus extremely preterm infants without fetal growth restriction. 3. Assessment of course of key metabolites throughout gestation identified in objective 2 and 3. 4. Correlation of amniotic fluid profiles with neonatal diseases, such as necrotizing enterocolitis, sepsis, and bronchopulmonary dysplasia, and identification of potential biomarkers in amniotic fluid for identifying extremely preterm infants at increased risk of these diseases. 5. Correlation of bacterial and metabolic composition of amniotic fluid with microbial colonization of the neonatal gut in the first month of life.	—

Measure

Time frame

The secondary outcome measures are: 1. Analysis of amniotic fluid profiles of extremely preterm infants exposed to inflammation in utero versus extremely preterm infants not exposed to inflammation in utero. 2. Analysis of amniotic fluid profiles of extremely preterm infants with fetal growth restriction versus extremely preterm infants without fetal growth restriction. 3. Assessment of course of key metabolites throughout gestation identified in objective 2 and 3. 4. Correlation of amniotic fluid profiles with neonatal diseases, such as necrotizing enterocolitis, sepsis, and bronchopulmonary dysplasia, and identification of potential biomarkers in amniotic fluid for identifying extremely preterm infants at increased risk of these diseases. 5. Correlation of bacterial and metabolic composition of amniotic fluid with microbial colonization of the neonatal gut in the first month of life.

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Countries

Netherlands

Outcome results