Immune development in early life

Immune development in early life - Immune development in early life

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38195

Enrollment

205

Registered

2012-11-06

Start date

2012-12-20

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Allergy Immune-mediated diseases

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results