The aim of this study is to characterize the composition of amniotic fluid, collected during preterm delivery, of extremely preterm infants (24-28 weeks), using novel molecular techniques. These approaches include microbial (e.g. IS-pro analysis)…
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Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Preterm birth remains a major global health issue. Extremely preterm infants,
born with gestational age below 28 weeks, are especially vulnerable to adverse
health outcomes. Necrotizing enterocolitis, an inflammatory disease of the
neonatal intestines, and sepsis, a systemic response to microbial invasion of
the bloodstream, are more common in this population. The pathogenesis of both
conditions has been linked to the immaturity of the preterm intestines and
preclinical alterations in the gut microbiome. It has been hypothesized that
amniotic fluid impacts the intra-uterine development of the fetal
gastro-intestinal tract as the intestines are exposed to amniotic fluid through
swallowing in utero. Previous studies on the characterization of amniotic fluid
have demonstrated that the constitution of amniotic fluid gradually changes
over the course of pregnancy. However, current literature still lacks knowledge
on the, potentially, critical changes, that occur in the content of amniotic
fluid. between the 24th and 28th week of pregnancy, their effect on the
development of the fetal gastro-intestinal tract and impact on the microbial
colonization of the neonatal gut.
Study objective
The aim of this study is to characterize the composition of amniotic fluid,
collected during preterm delivery, of extremely preterm infants (24-28 weeks),
using novel molecular techniques. These approaches include microbial (e.g.
IS-pro analysis) and metabolomic (e.g. (un)targeted metabolomics) techniques.
The impact of amniotic fluid on the neonatal gut colonization will be assessed
through analyses of neonatal stool samples, which are collected in line with
the eMINDS study.
Study design
In this multicenter observational cohort study, amniotic fluid will be isolated
from mothers delivering their infants extremely preterm. Two subgroups are of
particular interest due to their association with morbidity and mortality in
the neonatal phase: 1) preterm infants exposed to intra-uterine inflammation,
and 2) preterm infants with fetal growth restriction. To assess the impact of
the composition of amniotic fluid on the colonization of the neonatal
gastro-intestinal tract, neonatal stool samples are collected daily for the
first 28 days of life, according to the ongoing eMINDS study.
Study burden and risks
Collection of AF, which is generally discarded as biological waste, is
noninvasive, posing no additional strain on the obstetric patient. AF can
safely be isolated without interfering with practice of a C-section or a
vaginal delivery.
De Run 4600
Veldhoven 5504DB
NL
De Run 4600
Veldhoven 5504DB
NL
Listed location countries
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 (< 24 weeks), very preterm to moderate and
late preterm (28 + 0 - 36 + 6/7 weeks), and full term pregnancies (37 + 0 - 41
+ 6/7 weeks) (n = 150).
Inclusion criteria study population: If the obstetric patient is > 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 study population: Obstetric patients < 16 years of age
and/or mentally incompetent or with pregnancies complicated with major fetal
congenital or chromosomal comorbidities will be excluded from the study.
Exclusion criteria reference population: Obstetric patients < 16 years of age
and/or mentally incompetent or with pregnancies complicated with major fetal
congenital or chromosomal comorbidities will be excluded from the study.
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL86579.015.24 |