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Effect of Intrapartum Antibiotic Prophylaxis (IAP) on the Development of the Neonatal Gut Microbiota. (MICROBIOTA-SO)

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ClinicalTrials.gov Identifier: NCT02212002
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Luigi Corvaglia, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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 microbiota, type of feeding, hospitalization after birth and use of antibiotics and probiotics.

Gut microbiota of term infants, vaginally delivered and exclusively breastfed, shows a low count of C. difficile and E. coli and a high number of Bifidobacteria and Lactobacilli, which positively influence the host's immunity processes; hence, is considered to be ideally healthy.

Group B Streptococcus (GBS) represents one of the most important causes of neonatal infections and sepsis. Infants vaginally delivered may acquire GBS during the birth process from maternal vagina, cervix or rectum, where it resides in 10-20% of pregnant women. In the last decade, the incidence of early-onset GBS sepsis is significantly reduced, due to the introduction of GBS universal screening during late pregnancy and consequent intrapartum antibiotic prophylaxis (IAP) in GBS-positive women.

The use of antibiotics in early life is shown to alter the commensal gut microbiota, thereby impairing the balance between health and disease later in life. The effect of IAP on bacterial colonization of the infant's gut, however, has not been largely investigated. The investigators have previously evaluated the effect of IAP in a relatively small sample of exclusively breast-fed term infants vaginally delivered by means of molecular techniques; at 7 days of life there were several differences in microbiota composition between infants IAP-exposed and not exposed.

This observational prospective study thus aims to evaluate these differences in further detail, expanding the initial sample to formula-fed term infants and following up infants until one month of age. By including formula-fed infants, the investigators additionally aim to evaluate the influence of feeding type on the neonatal microbiota composition.


Condition or disease Intervention/treatment
Microbiota Drug: IAP

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Intrapartum Antibiotic Prophylaxis (IAP) on the Development of Neonatal Gut Microbiota
Study Start Date : May 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
Control
Control group: infants born to GBS-negative mothers, who thus did not receive any antibiotic treatment before/at delivery.
IAP
IAP group: infants born to GBS-positive mothers who have received adequate intrapartum antibiotic prophylaxis (IAP). According to the Institutional treatment protocol for GBS prophylaxis (derived from CDC guidelines), intravenous ampicillin is given every 4 hours until delivery (first dose 2 g, following doses 1 g each). IAP is considered adequate when the mother received at least two doses of ampicillin before delivery.
Drug: IAP
maternal IAP, consisting of intravenous ampicillin given every 4 hours until delivery (first dose 2 g, following doses 1 g each).




Primary Outcome Measures :
  1. Faecal bacterial count [ Time Frame: One month ]
    Reduction in the faecal bacterial count (Bifidobacterium spp., Lactobacillus spp. and Bacteroides fragilis), assessed in term and vaginally delivered infants, in relation to IAP exposition.



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Ages Eligible for Study:   up to 6 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
At least 60 infants (IAP group n=30, control group n=30), born at Sant'Orsola-Malpighi University Hospital and fulfilling the inclusion criteria will be enrolled.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212002


Locations
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Italy
Nursery, S.Orsola-Malpighi Hospital
Bologna, Italy, 40138
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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Responsible Party: Luigi Corvaglia, Associate Professor, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT02212002     History of Changes
Other Study ID Numbers: SO-2014-MICROBIOTA
12/2013/U/Oss ( Other Identifier: Ethic Committee of St. Orsola-Malpighi University Hospital (Bologna, Italy) )
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014

Keywords provided by Luigi Corvaglia, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
Group B Streptococcus
Intrapartum Antibiotic Prophylaxis
term infants
vaginal delivery
gut microbiota
feeding
molecular analysis
real-time PCR

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Ampicillin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents