Influences of external determinants on the physiological development and composition of the infant microbiome in healthy infants from birth during the first 6 years of life using novel molecular techniques. Subclinical and clinical disease, transmission, and risk factors of SARS-CoV-2 among children and their families: a household study within the Microbiome Healthy Infant Study

Completed

Conditions: infecties, virale infectieziekten
carriage
microbial colonisation
SARS-CoV-2
transmission
10004018
10006436

Registration Number: NL-OMON50226

Lead Sponsor: Spaarne Gasthuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 130

Inclusion Criteria

1. Neonates born after 37 weeks of gestational age
2. Born in the region Groot Kennemerland and Bollenstreek (draining on Spaarne
hospital in Hoofddorp or Kennemer Gasthuis in Haarlem).

Inclusion criteria for COVID-19 related part:
1. Household member of participating children in the birth cohort study
(including participating children themselves)
2. Written informed consent obtained from parents
3. Parents ability and willingness to adhere to protocol-specified procedures.

Exclusion Criteria

1.Severe perinatal/ neonatal/ maternal complications as asphyxia,
resuscitation, transfer to neonatal intensive care unit etc.
2.Major congenital anomalies.
3.Language barrier.
4.Intention to move outside the research area.
5.Parents under the age of 18 years.
For CoKids study: None

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Comparison of the composition of infant microbiome between infants born<br /><br>vaginally and infants born by caesarean section at several time points during<br /><br>the first 12 months of life.<br /><br>2. The dynamics of the infant nasopharyngeal and oral microbiome with age and<br /><br>in periods of respiratory infections.<br /><br>3. To study the human microbiome of children till age 6 in relation to health<br /><br>status, life style and environmental factors<br /><br><br /><br>CoKids:<br /><br>1. SARS-CoV-2 symptoms, infection, severity of disease and transmission</p><br>

Secondary Outcome Measures