Status:
UNKNOWN
Priming of the NEonatal Immune System by Transfer of Maternal Immunity
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
Else Kröner Fresenius Foundation
Conditions:
COVID-19
Maternal Vaccine Exposure
Eligibility:
All Genders
Brief Summary
Newborn babies and infants are susceptible to infections as their immune system is still immature. Maternal immune factors for example antibodies and immune cells mitigate this vulnerability. They are...
Detailed Description
Pregnant women are at increased risk of severe SARS-CoV-2 infections including ARDS and multi-organ failure and increased risk of miscarriages or premature birth. Although pregnant women were not incl...
Eligibility Criteria
Inclusion
- For mothers:
- ≥ 18 years
- Informed Consent
- For children:
- \- Informed Consent of the parents
Exclusion
- During pregnancy:
- Premature rupture of membranes (\>48h before delivery)
- Preterm Birth (\<32+0 weeks of pregnancy)
- Preeclampsia, HELLP syndrome and Eclampsia
- Twin-to-twin transfusion syndrome
- Hydrops fetalis
- Oncological disease of the mother
- Immunodeficiency, autoimmune or immunological disorder of the mother
- Further health conditions of mother or fetus that may influence the results of the study according to the opinion of the study team
- In children after delivery:
- Delivery \>48h after rupture of membranes
- Perinatal asphyxia (APGAR score at 10 minutes: \< 5 and/or blood acidosis (fetal umbilical artery pH: \< 7.0, arterial base deficit ≥ 12 mmol/L))
- High flow therapy or non-invasive or invasive ventilation after birth
- Treatment with vasopressors or inotropes after birth
- Treatment with intravenous antibiotics after birth
- Neonatal jaundice with need for an exchange transfusion
- Postnatal need for blood transfusions
- Further health conditions of the child that may influence the results of the study according to the opinion of the study team
Key Trial Info
Start Date :
June 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT05429047
Start Date
June 7 2022
End Date
December 1 2023
Last Update
July 7 2022
Active Locations (1)
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1
Hannover Medical School (Medizinische Hochschule Hannover, MHH)
Hanover, Lower Saxony, Germany, 30625