Clinical trial NCT02689700: Diaplacental Transfer of Anti-HCMV- and Anti-VZV-immunoglobulin G (IgG) -Antibodies at Premature and Mature Newborns
Official title: Examination of Diaplacental Transfer of IgG-antibodies Against Human Cytomegalovirus (HCMV) and Varicella-Zoster-Virus (VZV) at Premature and Mature Newborns
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Materno-fetal Transfer of Anti-HCMV-IgG
Materno-fetal Transfer of Anti-VZV-IgG
Keywords: Human Cytomegalovirus
Varicella Zoster Virus
Materno-fetal antibody transfer
Pregnancy
Gestational age
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 450
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 450 mother-child-pairs seropositive for HCMV and/or VZV

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.

Detailed description: For data gathering the investigators measure the main concentration of specific HCMV-/VZV-IgG-antibodies and the concentration of neutralizing IgG-antibodies against HCMV and VZV in maternal blood and in fetal bloodstream. Then the investigators compare the data of mother and newborn. Therefore, the investigators use the following blood samples:

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: To measure the concentration of specific HCMV-/VZV-IgG-antibodies in fetal bloodstream depending on gestational age at birth.
timeFrame: Newborn: immediately after birth; Mother +/- 3 days at birth
Secondary outcomes:
measure: Gauging the concentration of neutralizing IgG-antibodies against HCMV and VZV in fetal bloodstream depending on gestational age at birth.
timeFrame: Newborn: immediately after birth; Mother +/- 3 days at birth
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: Clinic of the Johann Wolfgang-Goethe Univeristy
state: Hesse
Study officials:
References:
citation: 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.
citation: Simister NE. Placental transport of immunoglobulin G. Vaccine. 2003 Jul 28;21(24):3365-9. doi: 10.1016/s0264-410x(03)00334-7.
citation: 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.
citation: 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.