Summary NOGBS study

Background

Streptococcus agalactiae and Escherichia coli are the most common pathogens causing neonatal sepsis and meningitis. Since the introduction in 1998 of antibiotic prophylaxis during delivery for pregnant women at increased risk of perinatal infection, the incidence of neonatal GBS disease has increased. The 7% chance of death from GBS disease in newborns has also not decreased since then. Better risk assessment and new preventive measures are urgently needed.

Study objective

The NOGBS study was initiated in 2018. An important goal of the study is to investigate the clinical presentation, risk factors, and outcomes following GBS and E. coli infections in children under 3 months of age in the Netherlands. A second goal is to determine the genetic properties of the GBS bacterium that contribute to disease severity. A third goal is to compare protective antibodies against GBS among patients, healthy controls, and their mothers. This research aims to contribute to the further development of GBS vaccines. Hopefully, this serious disease can be prevented in the future by vaccinating pregnant women against GBS during pregnancy.

Study design

Part 1 - National cohort of neonates with GBS or E. coli sepsis and/or meningitis

In the Netherlands, the bacterial strain from positive cerebrospinal fluid cultures is sent to the Dutch Reference Laboratory for Bacterial Meningitis. Additionally, for children <1 year old, the bacterial strain from positive blood cultures is also sent. This laboratory was established through a collaboration between RIVM and Amsterdam UMC, location AMC. The NOGBS researchers receive an anonymous notification from the reference laboratory for children in the Netherlands with a positive blood or cerebrospinal fluid culture for GBS or E. coli. If the child is <3 months old, the researchers contact the attending pediatrician. Subsequently, the pediatrician asks the parents of the patient if they wish to participate in the study. Pediatricians can also contact us directly to enroll a patient.

During hospitalization, we collect information about the disease course and take blood samples from the baby for research purposes (additional blood draws are not required for this). We also collect a blood sample from the mother. In these blood samples, we investigate antibodies against the GBS bacterium. Additionally, we take swabs from the anus and vagina of some mothers to investigate if they are carriers of the GBS bacterium.

Part 2 - Carrier cohort of pregnant women and their newborns

Pregnant women and their newborns can participate in this part of the NOGBS study. After delivery, we take blood samples from the mother and from the baby's umbilical cord. These blood samples are also tested for antibodies against the GBS bacterium. Around the time of delivery, we take swabs from the anus and vagina of the pregnant woman to investigate if she is a carrier of the GBS bacterium. In total, we aim to include approximately 1500 pregnant women, of whom approximately 100-300 will be carriers of the GBS bacterium. These mother-child pairs come into contact with the GBS bacterium but are unlikely to develop the disease.

• Admiraal de Ruyter Ziekenhuis
• Albert Schweitzer Ziekenhuis
• Alrijne Ziekenhuis
• Amsterdam UMC, locatie AMC
• Amphia Ziekenhuis
• Amstelland Ziekenhuis
• Bernhoven Ziekenhuis
• BovenIJ Ziekenhuis
• Canisius-Wilhelmina Ziekenhuis
• Het Diakonessenhuis
• Dijklander ziekenhuis 
• Elkerliek Ziekenhuis
• Erasmus MC
• Flevoziekenhuis
• Franciscus Gasthuis & Vlietland

• Gelre Ziekenhuizen
• Groene Hart Ziekenhuis
• Haaglanden Medisch Centrum
• Haga Ziekenhuis
• Isala Klinieken
• Leids Universiteit Medisch Centrum
• Maastricht UMC+
• Martini Ziekenhuis
• Maxima Medisch Centrum
• Meander Medisch Centrum
• Medisch Centrum Leeuwarden
• Medisch Spectrum Twente 
• Nij Smellinghe Ziekenhuis 
• Noordwest Ziekenhuisgroep, locatie Alkmaar

• OLVG, locatie Oost
• OLVG, locatie West
• Reinier de Graaf Gasthuis
• Rijnstate Ziekenhuis
• Slingeland Ziekenhuis
• Spaarne Gasthuis, locatie Haarlem
• St. Antonius Ziekenhuis
• St. Jansdal Ziekenhuis 
• Tergooi Ziekenhuis 
• Tjongerschans Ziekenhuis
• Treant Zorggroep
• UMC Utrecht
• VieCuri Medisch Centrum
• Zaans Medisch Centrum
• Ziekenhuis Gelderse Vallei
• Ziekenhuisgroep Twente 

Participating centers NOGBS part 2

• Amsterdam UMC, locatie AMC
• Elkerliek Ziekenhuis
• Haga Ziekenhuis
• Reinier de Graaf Gasthuis
• Spaarne Gasthuis, locatie Haarlem
• Tergooi Ziekenhuis

Contact research team

Principal investigator: dr. M.W. Bijlsma (pediatrician)
Coördinator:                  drs. M.A. Groenveld (physician-researcher)

If you have a patient who can be included in the NOGBS study or you are unsure whether the patient can be included, you can always call or email us:

The NOGBS is part of the EDCTP-2 program (grant RIA2018V-2304) supported by the European Union.

Study protocols (in Dutch)