NCT02689700

Brief Summary

The aim of the study is to determine the total concentration of HCMV- and VZV-specific IgG-antibodies and the total concentration of neutralizing antibodies against HCMV in neonatal bloodstream depending on gestational age at birth.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

4.4 years

First QC Date

February 19, 2016

Last Update Submit

March 4, 2017

Conditions

Materno-fetal Transfer of Anti-HCMV-IgGMaterno-fetal Transfer of Anti-VZV-IgG

Keywords

Human CytomegalovirusVaricella Zoster VirusMaterno-fetal antibody transferPregnancyGestational age

Outcome Measures

Primary Outcomes (1)

  • To measure the concentration of specific HCMV-/VZV-IgG-antibodies in fetal bloodstream depending on gestational age at birth.

    Measurement of HCMV and VZV-antibodies in the fetal and the maternal circulation

    Newborn: immediately after birth; Mother +/- 3 days at birth

Secondary Outcomes (1)

  • Gauging the concentration of neutralizing IgG-antibodies against HCMV and VZV in fetal bloodstream depending on gestational age at birth.

    Newborn: immediately after birth; Mother +/- 3 days at birth

Study Arms (2)

HCMV antibody-transfer

Materno-fetal HCMV antibody-Transfer form 24-41 weeks of gestation

Other: Blood samples

VZV antibody-transfer

Materno-fetal VZV antibody-Transfer form 24-41 weeks of gestation

Other: Blood samples

Interventions

Blood samplesOTHER

Taking blood form the umbilical cord (fetal circulation) and from the vein of the corresponding mother.

HCMV antibody-transferVZV antibody-transfer

Eligibility Criteria

Age1 Minute - 10 Minutes
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Approximately 450 mother-child-pairs seropositive for HCMV and/or VZV

You may qualify if:

  • HCMV and/or VZV-seropositive pregnant woman who signed written informed consent form.

You may not qualify if:

  • Newborns of underage mothers.
  • Newborns whose mother did not sign the written informed consent.
  • Pregnant women with a known hereditary or acquired immune deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of the Johann Wolfgang-Goethe Univeristy

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

Related Publications (4)

  • 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.

    PMID: 4164125RESULT

  • Simister NE. Placental transport of immunoglobulin G. Vaccine. 2003 Jul 28;21(24):3365-9. doi: 10.1016/s0264-410x(03)00334-7.

    PMID: 12850341RESULT

  • 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.

    PMID: 12683413RESULT

  • 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.

    PMID: 10891827RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Umbilical Cord blood; Blood from peripheral vene

MeSH Terms

Conditions

Chickenpox

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Horst Buxmann, PI

CONTACT

+49 69 6301horst.buxmann@kgu.de

Clara A Lüdeke, SI

CONTACT

+49 17662403039clara.luedeke@web.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2016

First Posted

February 24, 2016

Study Start

July 1, 2013

Primary Completion

December 1, 2017

Study Completion

July 1, 2018

Last Updated

March 7, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)