The aim of this study is to investigate whether the transfer of antibodies from mother to infant is less effective in infants with intrauterine growth restriction (FGR) compared to term-born infants without intrauterine growth restriction or who are…
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Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
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Intervention
Outcome measures
Primary outcome
Comparing the antibody concentrations against pertussis, diphtheria, and
tetanus, measured in both mother and infant directly after birth and the infant
at the age of two months, as well as the transmission ratio from mother to
infant, across the following five groups:
1. FGR mother-child pairs, with late-developed FGR after 32 weeks of gestation.
2. FGR mother-child pairs, with early-developed FGR before 32 weeks of
gestation.
3. SGA mother-infant pairs
4. Term non-FGR and non-SGA mother-infant pairs
5. Preterm non-FGR and non-SGA mother-infant pairs
Secondary outcome
We compare the antibody concentrations against measles and the respiratory
syncytial virus (RSV) immediately after birth among four groups:
1. Mother-child pairs with late FGR, after 32 weeks of pregnancy.
2. Mother-child pairs with early FGR, before 32 weeks of pregnancy.
3. Mother-child pairs with SGA.
4. Mother-child pairs with term-born children without FGR or SGA.
Additionally, we investigate the composition of the placentas, focusing on the
ratio and expression of FC receptors and B cells, in vaccinated pregnant women:
1. Late FGR pregnancies (n=10).
2. Term pregnancies with a normally growing child (n=10).
Furthermore, we describe the medical and sociodemographic characteristics of
the study population. We compare the growth, development, and occurrence of
infections in FGR and SGA children during the first six months with those of
term-born children of mothers who have not received maternal DKT vaccination
(historical cohort).
Background summary
Maternal vaccinations offer infants protection against infectious diseases from
the day of birth onwards till the start of their own vaccination schedule
(NIP). In the Netherlands, term infants of mothers vaccinated against
diphtheria, tetanus and pertussis (DTaP) receive a reduced and postponed
vaccination schedule compared to preterm infants. In 5-10% of infants fetal
growth restriction (FGR) occurs, mostly due to placental insufficiency.
Currently, FGR infants of vaccinated mothers receive the immunization schedule
according to their gestational age at birth. In case of a reduced and postponed
schedule, this may be insufficient for optimal protection because in FGR the
transplacental antibody transfer is probably negatively impacted. The transfer
of antibodies may depend on the concentration of antibodies the mother has
during pregnancy after vaccination. It is possible that the efficiency of this
transfer is influenced by the composition of the placenta and the presence of
FC receptors and possibly B cells.
Study objective
The aim of this study is to investigate whether the transfer of antibodies from
mother to infant is less effective in infants with intrauterine growth
restriction (FGR) compared to term-born infants without intrauterine growth
restriction or who are small for gestational age (SGA), in relation to the
duration of pregnancy.
Study design
We will conduct a prospective cohort study in collaboration with top-clinical
hospitals and university medical centers. We will assess antibody
concentrations against pertussis, diphtheria, tetanus and measles in blood of
women who are pregnant of a FGR or SGA infant and in the FGR and SGA infants
themselves. These antibody concentrations will be compared with two previous
studies, coordinated by the RIVM. Infants within these studies were born term
or preterm whilst none of them were FGR or SGA. Additionally, in a small group
of pregnancies with late FGR (n=10), placental material will be examined. This
will focus on the composition and the expression and ratio of FC receptors and
B cells. These placentas will be compared with those from mothers with a
normally growing child (n=10). We will relate the composition of the placentas
to the antibody concentrations found in the blood of the pregnant women and
their children.
Study burden and risks
In this study, we collect blood samples and placentas from pregnant women
vaccinated with DKT and their children. We focus on women pregnant with a child
experiencing intrauterine growth restriction, a child with low birth weight, or
a normally growing child. At birth, we collect blood from the mother via a
finger-stick and from the child via umbilical cord blood. When the child is two
months old, we take another blood sample with a heel-stick. These three blood
samples are used to examine the amount of antibodies present in the blood. The
finger- and heel-sticks may be briefly painful but pose no risks. The
collection of umbilical cord blood is painless for both the child and the
mother.
We ask 20 pregnant women, recruited at Radboudumc, to donate their placenta.
There are no risks associated with this. Additionally, we ask participants to
complete three questionnaires: one before birth, one when the child is two
months old, and one when the child is six months old. The questions cover the
health and sociodemographic information of the mother and child, vaccinations,
and previous pregnancies. A home visit also takes place when the child is two
months old. Completing the questionnaires and the home visit together takes
about one and a half to two hours, ensuring the mother is not overly burdened.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
inclusion criteria for pregnant woman:
• at least 18 years of age
• Being pregnant
• Receiving a standard routine Tdap vaccination after at least 20 weeks of
gestation in the routine NIP before study entry
• Receiving antenatal care in a secondary or tertiary care center because the
fetus has signs of FGR or SGA
• Signed IC from the parents.
• Parents who are willing to adhere to the protocol, perform all planned
visits, and sample collections for themselves and their newborn child (in The
Netherlands)
Inclusion criteria for infants (in utero):
• Fulfills the case definition of (50 participants per definition)
o SGA and not FGR, or
o Early fetal growth restriction, or
o Late fetal growth restriction
• Alive during inclusion
• Considered to be viable for at least the study period.
Exclusion criteria
- All women with one or more missing inclusion criteria
- history of having pertussis disease in the year prior to study entry.
- Known or suspected serious underlying condition that can interfere with the
results of the study such as but not limited to cancer, autoimmune disease,
immunodeficiency, seizure disorder or significant psychiatric illness.
-Receipt of immune modulating medication, e.g. oral corticosteroids,
biologicals.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87270.041.24 |