<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02212002</url>
  </required_header>
  <id_info>
    <org_study_id>SO-2014-MICROBIOTA</org_study_id>
    <secondary_id>12/2013/U/Oss</secondary_id>
    <nct_id>NCT02212002</nct_id>
  </id_info>
  <brief_title>Effect of Intrapartum Antibiotic Prophylaxis (IAP) on the Development of the Neonatal Gut Microbiota.</brief_title>
  <acronym>MICROBIOTA-SO</acronym>
  <official_title>Effect of Intrapartum Antibiotic Prophylaxis (IAP) on the Development of Neonatal Gut Microbiota</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Azienda Ospedaliero-Universitaria di Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Azienda Ospedaliero-Universitaria di Bologna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The colonization of the neonatal gastro-intestinal (GI) tract begins at birth and is&#xD;
      influenced by several factors, such as mode of delivery, gestational age, maternal intestinal&#xD;
      and vaginal microbiota, type of feeding, hospitalization after birth and use of antibiotics&#xD;
      and probiotics.&#xD;
&#xD;
      Gut microbiota of term infants, vaginally delivered and exclusively breastfed, shows a low&#xD;
      count of C. difficile and E. coli and a high number of Bifidobacteria and Lactobacilli, which&#xD;
      positively influence the host's immunity processes; hence, is considered to be ideally&#xD;
      healthy.&#xD;
&#xD;
      Group B Streptococcus (GBS) represents one of the most important causes of neonatal&#xD;
      infections and sepsis. Infants vaginally delivered may acquire GBS during the birth process&#xD;
      from maternal vagina, cervix or rectum, where it resides in 10-20% of pregnant women. In the&#xD;
      last decade, the incidence of early-onset GBS sepsis is significantly reduced, due to the&#xD;
      introduction of GBS universal screening during late pregnancy and consequent intrapartum&#xD;
      antibiotic prophylaxis (IAP) in GBS-positive women.&#xD;
&#xD;
      The use of antibiotics in early life is shown to alter the commensal gut microbiota, thereby&#xD;
      impairing the balance between health and disease later in life. The effect of IAP on&#xD;
      bacterial colonization of the infant's gut, however, has not been largely investigated. The&#xD;
      investigators have previously evaluated the effect of IAP in a relatively small sample of&#xD;
      exclusively breast-fed term infants vaginally delivered by means of molecular techniques; at&#xD;
      7 days of life there were several differences in microbiota composition between infants&#xD;
      IAP-exposed and not exposed.&#xD;
&#xD;
      This observational prospective study thus aims to evaluate these differences in further&#xD;
      detail, expanding the initial sample to formula-fed term infants and following up infants&#xD;
      until one month of age. By including formula-fed infants, the investigators additionally aim&#xD;
      to evaluate the influence of feeding type on the neonatal microbiota composition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At birth, the neonatal gastro-intestinal (GI) tract is rapidly colonized by maternal and&#xD;
      environmental bacteria; the first colonizers are generally aerobes and facultative anaerobes,&#xD;
      followed by strict anaerobes (e.g. Bifidobacterium spp., Bacteroides spp., and Clostridium&#xD;
      spp.). The composition of gut microbiota is influenced by several factors, such as mode of&#xD;
      delivery, gestational age, maternal intestinal and vaginal microbiota, type of feeding,&#xD;
      hospitalization after birth and use of antibiotics and probiotics.&#xD;
&#xD;
      Gut microbiota of term infants, vaginally delivered and exclusively breastfed, is considered&#xD;
      to be ideally healthy, with a low count of C. difficile and E. coli and a high number of&#xD;
      Bidifobacteria and Lactobacilli, which positively influence the host's health by activating&#xD;
      immunocompetent cells in the GI tract, promoting the production of secretory IgA and&#xD;
      increasing the bactericidal activity of neutrophils and cell-mediated immunity such as NK&#xD;
      cell activity.&#xD;
&#xD;
      Group B Streptococcus (GBS) is one of the most important causes of neonatal infections and&#xD;
      sepsis. Infants vaginally delivered may acquire GBS during the birth process from maternal&#xD;
      vagina, cervix or rectum, where it resides in approximately 10-20% of pregnant women. Since&#xD;
      the mid-90s, the incidence of early-onset GBS sepsis is significantly reduced, due to the&#xD;
      introduction of GBS universal screening during late pregnancy and consequent intrapartum&#xD;
      antibiotic prophylaxis (IAP) in GBS-positive women.&#xD;
&#xD;
      Recent data suggest that the use of antibiotics in early life could alter the commensal gut&#xD;
      microbiota, thereby impairing the balance between health and disease later in life. The&#xD;
      effect of IAP on bacterial colonization of the infant's gut has not been largely&#xD;
      investigated. Moreover, currently available data on this issue largely derive from studies&#xD;
      performed using culture-based techniques; however, accurate culture-based results are&#xD;
      influenced by the selection of the correct media, temperature, oxygen content and time for&#xD;
      growth, and for this reason as little as 10-50% of the entire gut bacteria are easily&#xD;
      cultured. Molecular techniques, based on the amplification of the 16S ribosomal bacterial RNA&#xD;
      gene to differentiate prokaryotic taxa, have been recently developed for the study of gut&#xD;
      microbiota, thus enabling a more detailed characterization of bacterial communities than&#xD;
      standard culture.&#xD;
&#xD;
      We have previously evaluated the effect of IAP in a relatively small sample of exclusively&#xD;
      breast-fed term infants vaginally delivered by means of molecular techniques; at 7 days of&#xD;
      life there were several differences in microbiota composition between infants IAP-exposed and&#xD;
      not exposed.&#xD;
&#xD;
      The aim of the present paper is thus to evaluate these differences in further detail,&#xD;
      expanding the initial sample and following up infants until one month of age. Influences of&#xD;
      type of feeding on microbiota composition are also explored.&#xD;
&#xD;
      Healthy term infants, vaginally delivered, with birth weight adequate for gestational age,&#xD;
      and whose mothers had been screened for GBS at 35-37 weeks gestation, are enrolled in the&#xD;
      study.&#xD;
&#xD;
      Infants are excluded if:&#xD;
&#xD;
        -  preterm or small/large for gestational age&#xD;
&#xD;
        -  born by caesarean section&#xD;
&#xD;
        -  the mother has received any antibiotic in the 4 weeks before delivery;&#xD;
&#xD;
        -  maternal IAP is performed for reasons other than GBS positivity (i.e. prolonged rupture&#xD;
           of membranes in GBS-negative women);&#xD;
&#xD;
        -  maternal IAP is inadequate;&#xD;
&#xD;
        -  maternal IAP is performed with antibiotics other than ampicillin, such as erythromycin;&#xD;
&#xD;
        -  the infant has major congenital malformations;&#xD;
&#xD;
        -  the infant develops signs of infection and/or received any antibiotic treatment after&#xD;
           birth;&#xD;
&#xD;
        -  the infant has any serious clinical conditions that contraindicated his/her&#xD;
           participation in the study.&#xD;
&#xD;
      Infants are allocated into two groups according to maternal GBS status and IAP:&#xD;
&#xD;
        -  IAP group: infants born to GBS-positive mothers who have received adequate IAP.&#xD;
           According to the Institutional treatment protocol for GBS prophylaxis (derived from CDC&#xD;
           guidelines), iv ampicillin is given every 4 hours until delivery (first dose 2 g,&#xD;
           following doses 1 g each). IAP is considered adequate if the mother has received at&#xD;
           least two doses of ampicillin before delivery.&#xD;
&#xD;
        -  Control group: infants born to GBS-negative mothers, who do not receive any antibiotic&#xD;
           treatment before/at delivery.&#xD;
&#xD;
      Written informed consent is obtained from each infant's parent/legal guardian when the infant&#xD;
      is about to be discharged from the nursery (48-72 hours of life). Patients' characteristics,&#xD;
      including gestational age, birth weight, gender, and Apgar score at 1' and 5' after birth,&#xD;
      are summarized in a specific case report form.&#xD;
&#xD;
      Two faecal samples from each infant are collected during follow up visits at 7 and 30 days of&#xD;
      life. At each visit, information on weight gain, clinical conditions, feeding, and on-going&#xD;
      treatments (i.e. use of prebiotics, probiotics, antibiotics), are collected from the infants'&#xD;
      parents.&#xD;
&#xD;
      After collection, faecal samples are put into numbered screw-capped sterile plastic&#xD;
      containers and immediately frozen at -80 °C, until they are processed for bacterial DNA&#xD;
      extraction.&#xD;
&#xD;
      Microbiological analyses are performed at the Department of Agricultural Sciences, University&#xD;
      of Bologna. Investigators who perform the analyses are blind to group identity of the infants&#xD;
      (IAP or control group).&#xD;
&#xD;
      Two hundred milligrams of faeces are used for bacterial DNA extraction using the QIAamp DNA&#xD;
      Stool Mini Kit (QIAGEN, West Sussex, UK). Extracted DNA is stored at -80 °C. The purity and&#xD;
      concentration of extracted DNA are determined by measuring the ratio of the absorbance at 260&#xD;
      and 280 nm (Infinite® 200 PRO NanoQuant, Tecan, Mannedorf, Switzerland).&#xD;
&#xD;
      Quantification of selected microbial groups (Lactobacillus spp., Bifidobacterium spp.,&#xD;
      Bacteroides fragilis) is performed with real-time PCR. Data obtained from amplification are&#xD;
      transformed to obtain the number of bacterial cells per gram of faeces, expressed as log&#xD;
      colony forming unit (CFU)/g.&#xD;
&#xD;
      The obtained data are analyzed using IBM SPSS Statistic version 20.0.0 (IBM Corporation, IBM&#xD;
      Corporation Armonk, New York, United States). Baseline characteristics in the IAP and control&#xD;
      groups are compared using the independent-samples Mann-Whitney U test for continuous&#xD;
      variables and chi-square test for categorical variables. The influence of IAP on faecal&#xD;
      bacterial count at 7 and 30 days of life will is evaluated using the independent-samples&#xD;
      Mann-Whitney U test. A hierarchical multiple regression analysis is performed in order to&#xD;
      estimate the effect of IAP on faecal bacterial count after controlling for type of infant&#xD;
      feeding (coded as a binary categorical variable: exclusive breastfeeding vs. any formula&#xD;
      feeding). A p value &lt;0.05 is considered as statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Faecal bacterial count</measure>
    <time_frame>One month</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">84</enrollment>
  <condition>Microbiota</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Control group: infants born to GBS-negative mothers, who thus did not receive any antibiotic treatment before/at delivery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IAP</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IAP</intervention_name>
    <description>maternal IAP, consisting of intravenous ampicillin given every 4 hours until delivery (first dose 2 g, following doses 1 g each).</description>
    <arm_group_label>IAP</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        At least 60 infants (IAP group n=30, control group n=30), born at Sant'Orsola-Malpighi&#xD;
        University Hospital and fulfilling the inclusion criteria will be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Term newborns (gestational age ≥ 37 weeks), vaginally delivered newborn&#xD;
&#xD;
          -  birth weight adequate for gestational age&#xD;
&#xD;
          -  mothers screened for GBS at 35-37 weeks gestation&#xD;
&#xD;
          -  Obtained written parental consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preterm or small/large for gestational age infants;&#xD;
&#xD;
          -  Infants born by caesarean section;&#xD;
&#xD;
          -  Infants admitted to the Neonatal Intensive Care Unit;&#xD;
&#xD;
          -  Infants with major congenital malformations;&#xD;
&#xD;
          -  Infants who received any antibiotic treatment after birth;&#xD;
&#xD;
          -  Signs of infection and/or any serious clinical conditions that contraindicate the&#xD;
             participation in the study;&#xD;
&#xD;
          -  Infants whose mother had received any antibiotic in the 4 weeks before delivery;&#xD;
&#xD;
          -  maternal IAP performed for reasons other than GBS positivity (i.e. prolonged rupture&#xD;
             of membranes in GBS-negative women);&#xD;
&#xD;
          -  inadequate maternal IAP;&#xD;
&#xD;
          -  maternal IAP performed with antibiotics other than ampicillin, such as erythromycin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nursery, S.Orsola-Malpighi Hospital</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>August 7, 2014</last_update_submitted>
  <last_update_submitted_qc>August 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Azienda Ospedaliero-Universitaria di Bologna</investigator_affiliation>
    <investigator_full_name>Luigi Corvaglia</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Group B Streptococcus</keyword>
  <keyword>Intrapartum Antibiotic Prophylaxis</keyword>
  <keyword>term infants</keyword>
  <keyword>vaginal delivery</keyword>
  <keyword>gut microbiota</keyword>
  <keyword>feeding</keyword>
  <keyword>molecular analysis</keyword>
  <keyword>real-time PCR</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02212002
org study id: SO-2014-MICROBIOTA
secondary id: 12/2013/U/Oss
nct id: NCT02212002
lead sponsor: 
has dmc: No
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.
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 strict anaerobes (e.g. Bifidobacterium spp., Bacteroides spp., and Clostridium
      spp.). The composition of gut microbiota 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, is considered
      to be ideally healthy, with a low count of C. difficile and E. coli and a high number of
      Bidifobacteria and Lactobacilli, which positively influence the host's health by activating
      immunocompetent cells in the GI tract, promoting the production of secretory IgA and
      increasing the bactericidal activity of neutrophils and cell-mediated immunity such as NK
      cell activity.

      Group B Streptococcus (GBS) is 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 approximately 10-20% of pregnant women. Since
      the mid-90s, 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.

      Recent data suggest that the use of antibiotics in early life could 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 has not been largely
      investigated. Moreover, currently available data on this issue largely derive from studies
      performed using culture-based techniques; however, accurate culture-based results are
      influenced by the selection of the correct media, temperature, oxygen content and time for
      growth, and for this reason as little as 10-50% of the entire gut bacteria are easily
      cultured. Molecular techniques, based on the amplification of the 16S ribosomal bacterial RNA
      gene to differentiate prokaryotic taxa, have been recently developed for the study of gut
      microbiota, thus enabling a more detailed characterization of bacterial communities than
      standard culture.

      We 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.

      The aim of the present paper is thus to evaluate these differences in further detail,
      expanding the initial sample and following up infants until one month of age. Influences of
      type of feeding on microbiota composition are also explored.

      Healthy term infants, vaginally delivered, with birth weight adequate for gestational age,
      and whose mothers had been screened for GBS at 35-37 weeks gestation, are enrolled in the
      study.

      Infants are excluded if:

        -  preterm or small/large for gestational age

        -  born by caesarean section

        -  the mother has received any antibiotic in the 4 weeks before delivery;

        -  maternal IAP is performed for reasons other than GBS positivity (i.e. prolonged rupture
           of membranes in GBS-negative women);

        -  maternal IAP is inadequate;

        -  maternal IAP is performed with antibiotics other than ampicillin, such as erythromycin;

        -  the infant has major congenital malformations;

        -  the infant develops signs of infection and/or received any antibiotic treatment after
           birth;

        -  the infant has any serious clinical conditions that contraindicated his/her
           participation in the study.

      Infants are allocated into two groups according to maternal GBS status and IAP:

        -  IAP group: infants born to GBS-positive mothers who have received adequate IAP.
           According to the Institutional treatment protocol for GBS prophylaxis (derived from CDC
           guidelines), iv ampicillin is given every 4 hours until delivery (first dose 2 g,
           following doses 1 g each). IAP is considered adequate if the mother has received at
           least two doses of ampicillin before delivery.

        -  Control group: infants born to GBS-negative mothers, who do not receive any antibiotic
           treatment before/at delivery.

      Written informed consent is obtained from each infant's parent/legal guardian when the infant
      is about to be discharged from the nursery (48-72 hours of life). Patients' characteristics,
      including gestational age, birth weight, gender, and Apgar score at 1' and 5' after birth,
      are summarized in a specific case report form.

      Two faecal samples from each infant are collected during follow up visits at 7 and 30 days of
      life. At each visit, information on weight gain, clinical conditions, feeding, and on-going
      treatments (i.e. use of prebiotics, probiotics, antibiotics), are collected from the infants'
      parents.

      After collection, faecal samples are put into numbered screw-capped sterile plastic
      containers and immediately frozen at -80 °C, until they are processed for bacterial DNA
      extraction.

      Microbiological analyses are performed at the Department of Agricultural Sciences, University
      of Bologna. Investigators who perform the analyses are blind to group identity of the infants
      (IAP or control group).

      Two hundred milligrams of faeces are used for bacterial DNA extraction using the QIAamp DNA
      Stool Mini Kit (QIAGEN, West Sussex, UK). Extracted DNA is stored at -80 °C. The purity and
      concentration of extracted DNA are determined by measuring the ratio of the absorbance at 260
      and 280 nm (Infinite® 200 PRO NanoQuant, Tecan, Mannedorf, Switzerland).

      Quantification of selected microbial groups (Lactobacillus spp., Bifidobacterium spp.,
      Bacteroides fragilis) is performed with real-time PCR. Data obtained from amplification are
      transformed to obtain the number of bacterial cells per gram of faeces, expressed as log
      colony forming unit (CFU)/g.

      The obtained data are analyzed using IBM SPSS Statistic version 20.0.0 (IBM Corporation, IBM
      Corporation Armonk, New York, United States). Baseline characteristics in the IAP and control
      groups are compared using the independent-samples Mann-Whitney U test for continuous
      variables and chi-square test for categorical variables. The influence of IAP on faecal
      bacterial count at 7 and 30 days of life will is evaluated using the independent-samples
      Mann-Whitney U test. A hierarchical multiple regression analysis is performed in order to
      estimate the effect of IAP on faecal bacterial count after controlling for type of infant
      feeding (coded as a binary categorical variable: exclusive breastfeeding vs. any formula
      feeding). A p value <0.05 is considered as statistically significant.
observational model: Case-Control
time perspective: Prospective
measure: Faecal bacterial count
time frame: One month
description: 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.
arm group label: Control
description: Control group: infants born to GBS-negative mothers, who thus did not receive any antibiotic treatment before/at delivery.
arm group label: IAP
description: 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.
intervention type: Drug
intervention name: IAP
description: maternal IAP, consisting of intravenous ampicillin given every 4 hours until delivery (first dose 2 g, following doses 1 g each).
arm group label: IAP
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Days
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
investigator full name: Luigi Corvaglia
investigator title: Associate Professor