Seroepidemiological Longitudinal RSV-specific Antibodies Transfer Study

Seroepidemiological Longitudinal RSV-specific Antibodies Transfer Study - SILVER

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53767

Enrollment

240

Registered

2022-02-24

Start date

2022-04-01

Completion date

Unknown

Last updated

2026-03-09

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

Conditions

prematuriteit early term neonate

Interventions

None listed

Eligibility

Age

No minimum to 64 Years

Inclusion criteria

Inclusion criteria: 1. Women >=18 years of age and pregnant. 2. Woman with hospitalization at the WKZ hospital due to imminent labor from 240/7 weeks of gestation. 3. Both parent(s)/legal guardian(s) must be willing to adhere to the protocol and sign informed consent. A signature from the mother is sufficient in case consent from the father cannot be obtained. 4. The maternal participant must be willing to accept maternal blood specimen collection and neonate specimens collection and relevant clinical and medical history data collection.

Exclusion criteria

Exclusion criteria: There are no exclusion criteria for the study. If mothers have a medical diagnosis or pregnancy-related condition that is suspected to impact the transplacental transfer rate, these confounding variables (comorbidities) will be documented and accounted for in the analyses.

Design outcomes

Primary

Measure	Time frame
1. To measure maternal naturally occurring neutralizing RSV antibody levels at birth as function of gestational age, and 2. To quantify transplacental antibody transfer ratios of RSV-specific antibodies in preterm babies depending on their gestational age group and compared to ratios obtained in term neonates	—

Secondary

Measure	Time frame
1. SILVER describes post-partum half-life of maternally acquired RSV-specific antibodies in preterm and full-term neonates. Preterm and full-term neonates will be followed up after birth to capture the decrease in maternally acquired RSV-specific antibodies in their first weeks of life. The SILVER study will describe the half-life of maternally acquired RSV-specific antibodies in neonates in relation to their gestational age, repeated blood-draws during hospitalization and health status and comorbidities. 2. SILVER will describe the health of the placenta in relation to antibody transfer. 3. SILVER will describe the correlation between RSV seasonality (using local public health surveillance data from RIVM) and observed antibodies of pregnant woman.	—

Measure

Time frame

1. SILVER describes post-partum half-life of maternally acquired RSV-specific antibodies in preterm and full-term neonates. Preterm and full-term neonates will be followed up after birth to capture the decrease in maternally acquired RSV-specific antibodies in their first weeks of life. The SILVER study will describe the half-life of maternally acquired RSV-specific antibodies in neonates in relation to their gestational age, repeated blood-draws during hospitalization and health status and comorbidities. 2. SILVER will describe the health of the placenta in relation to antibody transfer. 3. SILVER will describe the correlation between RSV seasonality (using local public health surveillance data from RIVM) and observed antibodies of pregnant woman.

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Countries

Netherlands

Outcome results