Effect of Azithromyacin on Microbiome And Growth in Infants (A-MAGI)
Not Applicable
- Conditions
- Health Condition 1: O269- Pregnancy related conditions, unspecified
- Registration Number
- CTRI/2021/10/037525
- Lead Sponsor
- The National Institutes of Diabetes and Digestive and Kidney Disorders NIDDK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
� Mother must be a participant in the A-PLUS trial
� Infant must be enrolled prior to discharge from the hospital after delivery
� Family must be planning to remain in the Nagpur area for the next 12 months
Exclusion Criteria
� Infants with multiple congenital anomalies (e.g., cyanotic congenital heart disease, spina bifida, or other nervous system malformations) will be excluded.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Infant length (length-for-age z-score)Timepoint: at 24-hrs, 1-week, 6-weeks and 3, 6, 9 and 12 months
- Secondary Outcome Measures
Name Time Method <br/ ><br>Outcome TimePoints <br/ ><br>� Additional growth indicators (weight-for-age and weight-for-length z-scores, middle-upper-arm-circumference and head circumference)Timepoint: at 5 time points (24-hours, 1-week, 6-weeks and 3, 6, & 9 months;� Antibiotic levels in women�s breastmilkTimepoint: at 5 time points (24-hours, 1-week, 6-weeks and 3, 6, & 9 months;� Infant GI microbiome indicators (alpha diversity, beta diversity, relative abundance of different taxa, metabolic capacity)Timepoint: at 5 time points (24-hours, 1-week, 6-weeks and 3, 6, & 9 months;� Maternal breastmilk and aereolar skin microbiome indicators (alpha diversity, beta diversity, relative abundance of different taxa)Timepoint: at 5 time points (24-hours, 1-week, 6-weeks and 3, 6, & 9 months