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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02212002 |
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Date of registration:
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06/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Intrapartum Antibiotic Prophylaxis (IAP) on the Development of the Neonatal Gut Microbiota.
MICROBIOTA-SO |
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Scientific title:
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Effect of Intrapartum Antibiotic Prophylaxis (IAP) on the Development of Neonatal Gut Microbiota |
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Date of first enrolment:
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May 2013 |
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Target sample size:
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84 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02212002 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Italy
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Term newborns (gestational age = 37 weeks), vaginally delivered newborn
- birth weight adequate for gestational age
- mothers screened for GBS at 35-37 weeks gestation
- Obtained written parental consent.
Exclusion Criteria:
- Preterm or small/large for gestational age infants;
- Infants born by caesarean section;
- Infants admitted to the Neonatal Intensive Care Unit;
- Infants with major congenital malformations;
- Infants who received any antibiotic treatment after birth;
- Signs of infection and/or any serious clinical conditions that contraindicate the
participation in the study;
- Infants whose mother had received any antibiotic in the 4 weeks before delivery;
- maternal IAP performed for reasons other than GBS positivity (i.e. prolonged rupture
of membranes in GBS-negative women);
- inadequate maternal IAP;
- maternal IAP performed with antibiotics other than ampicillin, such as erythromycin
Age minimum:
N/A
Age maximum:
6 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Microbiota
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Intervention(s)
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Drug: IAP
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Primary Outcome(s)
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Faecal bacterial count
[Time Frame: One month]
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Secondary ID(s)
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12/2013/U/Oss
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SO-2014-MICROBIOTA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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