Diaplacental Transfer of Anti-HCMV- and Anti-VZV-immunoglobulin G (IgG) -Antibodies at Premature and Mature Newborns
NCT ID: NCT02689700
Last Updated: 2017-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
450 participants
OBSERVATIONAL
2013-07-31
2018-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transfusion-Transmitted Cytomegalovirus Prevention in Neonates
NCT00000584
Investigation of the Passage of Antiviral Antibodies From Mother to Child
NCT05821764
TT-CMV Observational Birth Cohort Study
NCT00907686
Biomarkers of Cytomegalovirus Fetal Infection and Disease
NCT03090841
Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus
NCT01251744
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Mother: Venous blood sample taken at birth (+/- three days)
Newborn: Blood sample of umbilical cord (= fetal bloodstream) taken immediately after birth.
The investigators assign the data of each newborn (gestational age at birth) to the data of their respective mother for statistical evaluation. After finishing the study the investigators will destroy all residual blood.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HCMV antibody-transfer
Materno-fetal HCMV antibody-Transfer form 24-41 weeks of gestation
Blood samples
Taking blood form the umbilical cord (fetal circulation) and from the vein of the corresponding mother.
VZV antibody-transfer
Materno-fetal VZV antibody-Transfer form 24-41 weeks of gestation
Blood samples
Taking blood form the umbilical cord (fetal circulation) and from the vein of the corresponding mother.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood samples
Taking blood form the umbilical cord (fetal circulation) and from the vein of the corresponding mother.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Newborns whose mother did not sign the written informed consent.
* Pregnant women with a known hereditary or acquired immune deficiency
1 Minute
10 Minutes
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Johann Wolfgang Goethe University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. med. Horst Buxmann
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinic of the Johann Wolfgang-Goethe Univeristy
Frankfurt am Main, Hesse, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Hobbs JR, Davis JA. Serum gamma-G-globulin levels and gestational age in premature babies. Lancet. 1967 Apr 8;1(7493):757-9. doi: 10.1016/s0140-6736(67)91369-4. No abstract available.
Simister NE. Placental transport of immunoglobulin G. Vaccine. 2003 Jul 28;21(24):3365-9. doi: 10.1016/s0264-410x(03)00334-7.
Mussi-Pinhata MM, Pinto PC, Yamamoto AY, Berencsi K, de Souza CB, Andrea M, Duarte G, Jorge SM. Placental transfer of naturally acquired, maternal cytomegalovirus antibodies in term and preterm neonates. J Med Virol. 2003 Feb;69(2):232-9. doi: 10.1002/jmv.10271.
Linder N, Waintraub I, Smetana Z, Barzilai A, Lubin D, Mendelson E, Sirota L. Placental transfer and decay of varicella-zoster virus antibodies in preterm infants. J Pediatr. 2000 Jul;137(1):85-9. doi: 10.1067/mpd.2000.106902.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
040713 FRA Mat Fet CMV Antib
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.