Status:
COMPLETED
Effect of Intrapartum Antibiotic Prophylaxis (IAP) on the Development of the Neonatal Gut Microbiota.
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Microbiota
Eligibility:
All Genders
Up to 6 years
Brief Summary
The colonization of the neonatal gastro-intestinal (GI) tract begins at birth and is influenced by several factors, such as mode of delivery, gestational age, maternal intestinal and vaginal microbiot...
Detailed Description
At birth, the neonatal gastro-intestinal (GI) tract is rapidly colonized by maternal and environmental bacteria; the first colonizers are generally aerobes and facultative anaerobes, followed by stric...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT02212002
Start Date
May 1 2013
End Date
August 1 2014
Last Update
August 8 2014
Active Locations (1)
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1
Nursery, S.Orsola-Malpighi Hospital
Bologna, Italy, 40138