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The influence of Maternal Antibiotic use on Microbial colonisation in Infants


- candidate number24683
- NTR NumberNTR6000
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-jul-2016
- Secondary IDs2014.468 
- Public TitleThe influence of Maternal Antibiotic use on Microbial colonisation in Infants
- Scientific TitleThe impact of antibiotic treatment on neonatal intestinal colonization
- ACRONYMMAMI study
- hypothesisTiming of antibiotic administration during a cesarean section (prior to the cesarean section versus after clamping the cord) has a significant influence on the diversity of the developing neonatal intestinal microbiota and presence of specific bacterial species.
- Healt Condition(s) or Problem(s) studiedCaesarean section, Vaginally birth, Microbiome, Antibiotics
- Inclusion criteriaMother:
- Delivery at a gestational age > 36+6 weeks
- Vaginal or primary cesarean delivery
- Written informed consent

- Exclusion criteriaMother:
- Age < 18 years
- Antibiotic use during pregnancy
- Usage of immunosuppresive drugs up to 3 months prior to delivery
- BMI > 30
- Inflammatory bowel diseases, celiac disease
- Major gastro-intestinal operation in the past (e.g. bowel resection, gastric bypass)
- Diabetes mellitus type1 and 2, and gestational diabetes mellitus insuline dependent)
- intoxications (smoking, alcohol or drugs)

Exclusion after delivery
Mother
- Antibiotic use during first month

Neonate
- Antibiotic use during first month
- Usage of immunosuppresive drugs during first month
- Congenital gastro-intestinal disease
- Gastro-intestinal operation during first month
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2015
- planned closingdate
- Target number of participants60
- Interventions- 20 women will be treated according the current protocol on antibiotic administration (antibiotic administration after clampsing of the umbilical cord);
- 20 women will be treated according to the NVOG protocol (administration of antibiotics just prior to skin incision)
- 20 women admitted for outpatient vaginal delivery will be asked to participate in this study (providing baseline characteristics)

From each participating woman, one rectal swab and one vaginal swab will be collected closely prior to delivery.

Directly after delivery, oneoral swab will be collected from the neonate. In addition, neonatal fecal samples will be collected on the 1st, 7th and 28th day after birth. Antibiotic levels will be determined from the umbilical cord blood from women assigned to the antibiotic administration prior to skin incision
- Primary outcome{1. To describe and compare intestinal microbiome colonisation (by means of IS-pro) of neonates born by cesarean section, in terms of timimng of antibiotics treatment: prior to caesarean section (NVOG protocol) or after clamping of the umbilical cord (currently used protocol).
- Secondary outcome{-To describe and compare intestinal microbiome colonisation of vaginally delivered neonates with those born by caesarean section by means of IS-pro analysis.
- To evaluate effects of maternal vaginal and rectal microbiota composition on neonatal gut microbiota colonisation.
- Timepoints- Postnatal age 0 (day of birth)
- Postnatal age 7 days
- Postnatal age 28 days
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.I.P. Vries, de
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.I.P. Vries, de
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD25-jul-2016 - 29-sep-2016


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