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

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi; IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Treatments: Ampicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular

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