Immune development in early life

Completed

Conditions: Allergy
Immune-mediated diseases
10027665
10047438
10028920

Registration Number: NL-OMON38195

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 205

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A standard profile of the developing immune system will be generated with<br /><br>description of cytokines, chemokines and adipokines at different time points in<br /><br>the first week of life. Cord blood and peripheral blood samples will be<br /><br>obtained, the latter taken during the newborn (heel prick) screening and during<br /><br>the routine controls for glucose levels if applicable. From all children a<br /><br>sample of saliva will be taken simultaneously with the blood drawings.<br /><br>Cytokine, chemokine and adipokine profiles will be measured with a multiplex<br /><br>assay (Luminex xMAP technology). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>We will evaluate pathological conditions similarly to detect early pathological<br /><br>changes and to use these as biomarkers for early intervention or preventive<br /><br>measurements. The pathological condition are sepsis, postnataal acquired CMV<br /><br>infection and perinatale effects of maternal PCOS.</p><br>