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

NCT02212002 | Completed

• 2 other identifiers: SO-2014-MICROBIOTA12/2013/U/Oss
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbiota

Keywords

Group B Streptococcus; Intrapartum Antibiotic Prophylaxis; term infants; vaginal delivery; gut microbiota; feeding; molecular analysis; real-time PCR

Outcome Measures

Primary Outcomes (1)

• Faecal bacterial count

  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.

  One month

Study Arms (2)

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

Interventions

IAP DRUG

maternal IAP, consisting of intravenous ampicillin given every 4 hours until delivery (first dose 2 g, following doses 1 g each).

IAP

Eligibility Criteria

• Age: Up to 6 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Nursery, S.Orsola-Malpighi Hospital

Bologna, 40138, Italy

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 8, 2014
• Study Start: May 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 8, 2014

Record last verified: 2014-08

Locations

IT (1)