Antibiotics and Immune Responses in infants

Recruiting

• Conditions: eonatal intestinal dysbiosis; Neonatal intestinal dysbiosis; Inflammatory and Immune System - Normal development and function of the immune system; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12617000856314
• Lead Sponsor: Women's and Children's Health Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-09
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Healthy term infant (at least 37 weeks gestation)
2. Infant expected to have routine immunisation according to the National Immunisation Program (NIP)
3. Infant delivered vaginally

Exclusion Criteria

1, Infant delivered by caesarean section
2. Infant has a confirmed sepsis (defined by laboratory confirmed bacterial infection in blood cultures or CSF)
3. Mother or infant has a known or suspected disorder of the immune system that would prevent an immune response to the vaccines, such as participant with congenital or acquired immunodeficiency or those receiving systemic immunosuppressive therapy.
4. Infant has suspected or confirmed HIV, major congenital abnormality or serious illness.
5. Mother or infant is participating in a clinical study that may interfere with participation in, or outcomes of this study
6.Mother of infant had a recorded Body Mass Index >30kg/m2 at a first trimester antenatal visit

Study & Design

• Study Type: Observational
• Study Design: Not specified