Home Research NOGBS study Include patient in part 1

NOGBS study

National prospective cohort study of children <3 months with GBS or E. coli sepsis or meningitis.

In- and exclusion criteria

Inclusion criteria:

  • Patient aged 0-90 days with
  • Positive blood culture or cerebrospinal fluid culture for GBS
  • Positive blood culture or cerebrospinal fluid culture for E. coli

Exclusion criterion:

  • Neurosurgical material in situ

Practical procedure

Note: Each hospital has specific arrangements regarding different study components. 

Contact NOGBS researchers (nogbs@amsterdamumc.nl or 020-5661564) for assignment of a study number (CRF) and additional information specific to each hospital if considering inclusion.

  1. Discuss the study with parents and provide patient information folder (see PIF per hospital).
     
  2. Informed consent procedure: There are 4 consent forms (C1 to C4); lack of consent for one component does not affect the others:  

    • C1 (study participation child): signed by both parents + investigator

    • C2 (biobank storage): signed by both parents + investigator

    • C3 (study participation mother): signed by mother + investigator

    • C4 (biobank storage): signed by mother + investigator
       

  3. Blood collection from patient and mother:
    • Serum baby: collect 0.5-2 ml clot blood (red/yellow tube - preferably at least 2 tubes) during routine collection/IV placement. Note study number (K...) on tube.
    • Serum mother: collect 5-10 ml clot blood (red/yellow tube). Note study number (M...) on tube.
    • Other material (differs per hospital)
      • CSF: Contact local laboratory, store leftover fluid in lab (-70°C) marked with NOGBS study and CRF number. NOGBS researcher will collect this 3 times per year.
      • Breastmilk (for Post-ICHC/NICU centers): Fill at least two cups from NOGBS study kit, label with sticker, note CRF number, take cups to local lab for freezing/storage.
      • Urine mother (for Post-ICHC/NICU centers): Fill at least two cups from NOGBS study kit, label with sticker, note CRF number, take cups to local lab for freezing/storage.
      • Rectovaginal swab mother (for Post-ICHC/NICU centers): Self-collect rectovaginal swab, submit to local microbiology.
         
  4. Complete online CRF form via Castor. Login details will be emailed by NOGBS study investigator. After logging in, click "all records" of NOGBS study, then "Create a new record". Ensure correct hospital (institute) is filled in, project number does not matter.
     
  5. Send copies of consent forms and admission/ER and discharge letters to NOGBS study investigator.

Required forms for inclusion NOGBS part 1