Actively Recruiting
Prenatal Antibiotics and Breast Milk / Neonatal IgA
Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2024-06-26
82
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
Sponsors
F
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead Sponsor
H
Humanitas Hospital, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this biological study, the investigators will evaluate the levels of breast milk IgA, neonatal fecal IgA, and the composition of breast milk and fecal microbiota throughout the first 12 months of life in neonates born to mothers treated or not treated with prenatal antibiotics for at least 7 days after the 32nd weeks of gestation
CONDITIONS
Official Title
Prenatal Antibiotics and Breast Milk / Neonatal IgA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent is provided
- Antibiotic treatment for at least 7 consecutive days after 32 weeks of pregnancy, or no systemic antibiotics during pregnancy for control group
- Intention to exclusively breastfeed the neonate as long as possible during the first year of life
You will not qualify if you...
- No written informed consent
- Intention to exclusively formula feed or significant concerns about breastfeeding
- Maternal antibiotic treatment shorter than 7 days
- Pre-existing maternal immune-mediated disorders, including immunodeficiencies and chronic infections
- Delivery before 34 weeks of gestation
- Antibiotic administration to neonates within the first week of life after birth
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
Research Team
C
Carlo Pietrasanta, MD,PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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