1. To describe the development of the nature of the immune system in early life in a profile of cytokines, chemokines and adipokines. 2. To evaluate less invasive methods like the use of saliva or less demanding methods like the use of dried bloods…
ID
Source
Brief title
Condition
- Immune disorders NEC
- Viral infectious disorders
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A standard profile of the developing immune system will be generated with
description of cytokines, chemokines and adipokines at different time points in
the first week of life. Cord blood and peripheral blood samples will be
obtained, the latter taken during the newborn (heel prick) screening and during
the routine controls for glucose levels if applicable. From all children a
sample of saliva will be taken simultaneously with the blood drawings.
Cytokine, chemokine and adipokine profiles will be measured with a multiplex
assay (Luminex xMAP technology).
Secondary outcome
We will evaluate pathological conditions similarly to detect early pathological
changes and to use these as biomarkers for early intervention or preventive
measurements. The pathological condition are sepsis, postnataal acquired CMV
infection and perinatale effects of maternal PCOS.
Background summary
Neonatal exposure to antigens usually leads to tolerance. After birth, the
immune system is primed by all kind of environmental factors and finally adult
immune responses will protect efficiently against potentially harmful microbes.
We are still badly informed about this immunological transition in the early
neonatal period as we do not know what happens with this so called priming of
the immune system. Available data are scarce, incomplete and mainly derived
from epidemiological studies and assumptions on biological processes from
studies with animal models and human cord blood. A better insight in the
maturation of the neonatal immune system is essential to understand the
development of immune mediated diseases and for development of possible
therapeutic or preventive strategies.
Study objective
1. To describe the development of the nature of the immune system in early life
in a profile of cytokines, chemokines and adipokines.
2. To evaluate less invasive methods like the use of saliva or less demanding
methods like the use of dried bloods spots for analysis of these profiles.
3. To describe the immunological development for pathological conditions like
sepsis, postnatal acquired cytomegalovirus (CMV) infections and perinatal
effects of maternal polycystic ovary syndrome (PCOS). Subsequently identifying
biomarkers for these conditions.
Study design
Observational, descriptive and non-therapeutic study using cord blood,
peripheral blood and saliva samples of newborns for in vitro experiments.
Study burden and risks
Risks and burden for the subjects are related to the drawing of the blood
samples only and are brought to a minimum since there is a clinical indication
to draw blood and this will be performed by experienced professionals. We will
use a maximum of 3 samples and 0.5 ml extra blood will be drawn per sample.
Extra blood will only be drawn when the total volume of drawn blood does not
exceed 3 ml. A sample of saliva will be taken with a special swab approved for
infants below 6 months of age. The participants will not directly benefit from
the outcome of the study.
Lundlaan 6
Utrecht 3584 EA
NL
Lundlaan 6
Utrecht 3584 EA
NL
Listed location countries
Age
Inclusion criteria
- Healthy term (37-42 weeks) newborns born in the hospital on maternal indication after an uncomplicated pregnancy and delivery
- Diabetes group: Newborns from mothers with diabetes mellitus or diabetes gravidarum at risk for hypoglycaemia and who will routinely have several glucose controls in the first 24-48 hours after birth
- Sepsis group: Newborns with a clinical diagnosed sepsis
- PCOS group: Newborns from mothers with PCOS
- CMV infection group: Preterm born children (AD<32 weeks) with a postnatal acquired CMV infection and matched controls with similar clinical and patient characteristics but without a CMV infection
Exclusion criteria
- Complications during pregnancy (HELLP, pre-ecmplampsia, infection) except for the pathological conditions under investigation
- Smoking during pregnancy
- Use of immune-modulating medication during pregnancy
- Use of antibiotics by the mother in two weeks before delivery
- Perinatal complications not related to inclusion criteria
- Prematurity (GA<36 weeks) or dysmaturity (birth weight < -2 SD) except for the preterm born children in the CMV infected population or their controls
- Immunological disorders like velocardiofacial syndrome, DiGeorge syndrome
- Chromosomal disorders
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 | NL37428.041.12 |